A randomised, controlled trial to investigate the effect of a six-week intensified pharmacological treatment for schizophrenia compared to treatment as usual in subjects who had a first-time treatment failure on their first-line treatment.

2023-506602-39-00 Protocol INTENSIFY SZ Therapeutic use (Phase IV) Authorised, recruiting

Start 1 Aug 2024 · Status Authorised, recruiting · 4 EU/EEA countries · 12 sites · Protocol INTENSIFY SZ

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruiting
Participants planned 418
Countries 4
Sites 12

schizophrenia, schizoaffective disorder, schizophrenifom disorder

The primary objective is to compare the treatment response (baseline; visit 2 vs. end of treatment; visit 4), expressed as symptom severity at six weeks and changes in symptom severity from baseline as measured through the Positive And Negative Syndrome Scale (PANSS) under an early-intensified pharmacological treatment…

Key facts

Sponsor
Universitair Medisch Centrum Utrecht
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Mental Disorders [F03]
Trial duration
1 Aug 2024 → ongoing
Decision date (initial)
2023-12-28
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
European Commission

External identifiers

EU CT number
2023-506602-39-00
ClinicalTrials.gov
NCT05958875

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective is to compare the treatment response (baseline; visit 2 vs. end of treatment; visit 4), expressed as symptom severity at six weeks and changes in symptom severity from baseline as measured through the Positive And Negative Syndrome Scale (PANSS) under an early-intensified pharmacological treatment to that under treatment as usual. Mean change from baseline (visit 2) in symptom severity as measured by the PANSS total score at six weeks (visit 4) will be compared between the two treatment arms (EIPT vs. TAU) for the lines of treatment separately (subgroup analysis wherein the focus will be on participants who had a first time treatment failure on their first-line treatment) and for the group as a whole (irrespective of line of treatment).

Secondary objectives 10

  1. To compare changes in PANSS subscale scores (positive, negative and general) between the two treatment arms.
  2. To compare changes in severity and improvement in global functioning assessed by the Clinical Global Impression Scale (CGI) between the two treatment arms.
  3. To compare changes in the levels of depression and anxiety between the two treatment arms.
  4. To compare changes in quality of life and functioning measures between the two treatment arms.
  5. To compare changes in cognitive performance between the two treatment arms.
  6. To compare the proportion of participants (EIPT vs. TAU) that is in symptomatic remission at visit 4.
  7. To compare presence of adverse events (related and unrelated) between the two treatment arms.
  8. To compare use of concomitant medication between the two treatment arms.
  9. To compare premature treatment discontinuation (timing and reason) between the two treatment arms.
  10. To compare changes in suicidal ideation between the two treatment arms.

Conditions and MedDRA coding

schizophrenia, schizoaffective disorder, schizophrenifom disorder

VersionLevelCodeTermSystem organ class
21.1 PT 10039621 Schizoaffective disorder 100000004873
21.1 PT 10039647 Schizophreniform disorder 100000004873
20.0 PT 10039626 Schizophrenia 100000004873

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Randomisation during the entire study
After it is confirmed during the screening visit that the patient is eligible (and reconfirmed during visit 2), patient can be randomised. The randomisation is applicable for the entire study.
 Randomised Controlled Single [{"id":173832,"code":2,"name":"Investigator"}] Early intensified pharmacologiclal treatment (EIPT): Clozapine
Treatment as usual (TAU): Any second-line antipsychotic

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. In- or out patients, at least 18 years of age up until 70.
  2. Being willing and able to provide written informed consent. Having a legal guardian to cosign is allowed. Informed consent will be signed at visit 1, before any study procedure.
  3. Female participants of child bearing potential must use effective contraception during the trial as per the requirements of the applicable SmPCs and should have a negative pregnancy test at visit 1 or 2 (before; randomisation; section 8.2).
  4. Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder, according to DSM-5. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2).
  5. Participant experiences his/her first treatment failure due to lack of efficacy in the current episode, as confirmed by CGI-I ≥3; this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within an effective dose range as specified in the Summary of Product Characteristics. However, other treatments are accepted as long as they are in line with clinical guidelines and protocols for schizophrenia.
  6. Participant and clinician intend to change pharmacotherapeutic treatment.
  7. A minimum symptom severity threshold needs to be present (moderate level; see below) and subject needs to experience functional impairment. - The minimum symptom severity threshold is at least 2 PANSS positive or negative items with a score of 4, or at least one PANSS positive or negative item with a score of 5 - Functional impairment is defined as a score of 5 or higher on any of the three scales of the Sheehan Disability Scale (SDS).

Exclusion criteria 12

  1. Being pregnant or breastfeeding.
  2. Participants with active suicidal ideation with some intent to act, without specific plan (“Yes” to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS)) or active suicidal ideation with specific plan and intent (“Yes” to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the subject to participate in the study
  3. Participant meets criteria for current substance use disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). Nicotine dependency is allowed, as well as mild and moderate alcohol and/or cannabis use disorder (as defined by MINI v7.0.2). Severe alcohol and/or cannabis use disorder are not allowed.
  4. Participants that have any clinically significant abnormal values on the local laboratory test (especially ANC/WBC and liver values), electrocardiogram (ECG) or physician examinations.
  5. Participants dependent on the sponsor, investigator or trial site must be excluded from participation in advance.
  6. Participants have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
  7. Participants who meet the modified Andreasen criteria for remission.
  8. Participant has used clozapine in the past.
  9. Partcipant has a known intolerance to clozapine or to all TAU medication options.
  10. Participant has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit 1.
  11. Meeting any of the contraindications of clozapine * or to all TAU medication options, as specified within the applicable SmPC.
  12. Participant experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Mean change from baseline (visit 2) in symptom severity as measured by the PANSS total score at six weeks (visit 4) will be compared between the two treatment arms (EIPT vs. TAU. )

Secondary endpoints 10

  1. Change from baseline (visit 2) in PANSS subscale scores (positive, negative and general) at visit 4; EIPT vs TAU.
  2. 2.a. Change from baseline (visit 2) in the severity sub-score of the Clinical Global Impression Scale (CGI 1) at visit 4; EIPT vs TAU. 2.b. Improvement sub-score of the Clinical Global Impression Scale (CGI 1) at visit 4; EIPT vs TAU.
  3. Changes from baseline (visit 2) in total Hospital Anxiety and Depression Scale (HADS) total score and anxiety and depression subscales at visit 4; EIPT vs TAU.
  4. Change from baseline (visit 2) in quality of life and functioning measures (Q-LES-Q-SF, LAPS, QLS-100 and SDS) at visit 4; EIPT vs TAU.
  5. Changes from baseline (visit 2) on Trail Making Test, Digit Symbol Substitution Test, Rey Auditory Verbal Learning Test as well as the Perceived Deficits Questionnaire at visit 4; EIPT vs TAU.
  6. Presence of symptomatic remission at visit 4; EIPT vs TAU. Remission is defined as meeting the PANSS modified Andreasen criteria (Low scores (≤3) P1. Delusions; P3. Hallucinatory behavior; P2. Conceptual disorganization; N1. Blunted affect; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity and flow of conversation; G5. Mannerisms/posturing; G9. Unusual thought content.
  7. Presence of reported adverse events (related and unrelated to treatment) as measured through General Assessment of Side Effects Scale (GASE) and reported spontaneously througout the study; EIPT vs TAU.
  8. Concomitant medication use throughout the study; EIPT vs TAU.
  9. Premature treatment discontinuation before visit 4 and time to treatment discontinuation and reported reason of discontinuation; EIPT vs TAU.
  10. Changes on the Columbia-Suicide Severity Rating Scale (C-SSRS) throughout the study; EIPT vs TAU.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Clozapine

SCP713118 · ATC

Active substance
Clozapine
Route of administration
ORAL
Max daily dose
900 mg milligram(s)
Max total dose
37800 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AH02 — CLOZAPINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 22

—

SCP136372 · ATC

Route of administration
ORAL
Max daily dose
50 mg milligram(s)
Max total dose
2100 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AF05 — ZUCLOPENTHIXOL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lurasidone

SCP15585304 · ATC

Active substance
Lurasidone
Route of administration
ORAL
Max daily dose
148 mg milligram(s)
Max total dose
6216 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AE05 — LURASIDONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

—

SCP187579 · ATC

Route of administration
SUBLINGUAL USE
Max daily dose
20 mg milligram(s)
Max total dose
840 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AH05 — ASENAPINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Clotiapine

SCP155131 · ATC

Active substance
Clotiapine
Substance synonyms
Clothiapine
Route of administration
ORAL
Max daily dose
360 mg milligram(s)
Max total dose
15120 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AH06 — CLOTIAPINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluoxetine Hydrochloride

SCP1000963 · ATC

Active substance
Fluoxetine Hydrochloride
Substance synonyms
N-METHYL-3-PHENYL-3-[4-(TRIFLUOROMETHYL)PHENOXY]PROPAN-1-AMINE HYDROCHLORIDE
Route of administration
ORAL
Max daily dose
20 mg milligram(s)
Max total dose
840 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AH03 — OLANZAPINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paliperidone

SCP12568546 · ATC

Active substance
Paliperidone
Substance synonyms
9-HYDROXYRISPERIDONE
Route of administration
ORAL
Max daily dose
12 mg milligram(s)
Max total dose
504 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AX13 — PALIPERIDONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Aripiprazole

SCP13257562 · ATC

Active substance
Aripiprazole
Route of administration
ORAL
Max daily dose
30 mg milligram(s)
Max total dose
1260 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AX12 — ARIPIPRAZOLE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Levomepromazine Hydrochloride

SCP139822 · ATC

Active substance
Levomepromazine Hydrochloride
Substance synonyms
METHOTRIMEPRAZINE HYDROCHLORIDE
Route of administration
ORAL
Max daily dose
600 mg milligram(s)
Max total dose
25200 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AA02 — LEVOMEPROMAZINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ziprasidone

SCP1697872 · ATC

Active substance
Ziprasidone
Route of administration
ORAL
Max daily dose
160 mg milligram(s)
Max total dose
6720 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AE04 — ZIPRASIDONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Flupentixol Decanoate

SCP148464 · ATC

Active substance
Flupentixol Decanoate
Substance synonyms
2-[4-[(3E)-3-[2-(TRIFLUOROMETHYL)THIOXANTHEN-9-YLIDENE]PROPYL]PIPERAZIN-1-YL]ETHYL DECANOATE, FLUPENTHIXOL DECANOATE
Route of administration
ORAL
Max daily dose
40 mg milligram(s)
Max total dose
1680 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AF01 — FLUPENTIXOL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Perphenazine Decanoate

SCP13232709 · ATC

Active substance
Perphenazine Decanoate
Route of administration
ORAL
Max daily dose
24 mg milligram(s)
Max total dose
1008 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AB03 — PERPHENAZINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pregabalin

SCP1025295 · ATC

Active substance
Pregabalin
Route of administration
ORAL
Max daily dose
800 mg milligram(s)
Max total dose
33600 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AH04 — QUETIAPINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sertindole

SCP153592 · ATC

Active substance
Sertindole
Route of administration
ORAL
Max daily dose
20 mg milligram(s)
Max total dose
840 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AE03 — SERTINDOLE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Diazepam

SCP136171 · ATC

Active substance
Diazepam
Route of administration
ORAL
Max daily dose
1200 mg milligram(s)
Max total dose
50400 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AL01 — SULPIRIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Chlorpromazine Hydrochloride

SCP1139892 · ATC

Active substance
Chlorpromazine Hydrochloride
Substance synonyms
AMINAZINE
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
12600 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AA01 — CHLORPROMAZINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Promazine Hydrochloride

SCP1057557 · ATC

Active substance
Promazine Hydrochloride
Route of administration
ORAL
Max daily dose
400 mg milligram(s)
Max total dose
16800 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AA03 — PROMAZINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

—

SCP130832 · ATC

Route of administration
INTRAMUSCULAR
Max daily dose
100 mg milligram(s)
Max total dose
300 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AB02 — FLUPHENAZINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Brexpiprazole

SCP31637163 · ATC

Active substance
Brexpiprazole
Substance synonyms
OPC-34712
Route of administration
ORAL
Max daily dose
4 mg milligram(s)
Max total dose
168 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AX16 — BREXPIPRAZOLE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Amisulpride

SCP139272 · ATC

Active substance
Amisulpride
Substance synonyms
APD421
Route of administration
ORAL
Max daily dose
800 mg milligram(s)
Max total dose
33600 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AL05 — AMISULPRIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cariprazine

SCP25779878 · ATC

Active substance
Cariprazine
Substance synonyms
RGH-188
Route of administration
ORAL
Max daily dose
6 mg milligram(s)
Max total dose
252 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AX15 — CARIPRAZINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Risperidone

SCP1020186 · ATC

Active substance
Risperidone
Substance synonyms
3-[2-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]ETHYL]-2-METHYL-6,7,8,9-TETRAHYDROPYRIDO[2,1-B]PYRIMIDIN-4-ONE
Route of administration
ORAL
Max daily dose
6 mg milligram(s)
Max total dose
252 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AX08 — RISPERIDONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Haloperidol Decanoate

SCP12478791 · ATC

Active substance
Haloperidol Decanoate
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
420 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AD01 — HALOPERIDOL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Utrecht

37 Total trials 17 Recruiting 14 Ended
Academic / Non-commercial
Sponsor organisation
Universitair Medisch Centrum Utrecht
Address
Heidelberglaan 100
City
Utrecht
Postcode
3584 CX
Country
Netherlands

Scientific contact point

Organisation
Universitair Medisch Centrum Utrecht
Contact name
Dr. Inge Winter

Public contact point

Organisation
Universitair Medisch Centrum Utrecht
Contact name
Dr. Inge Winter

Third parties 4

OrganisationCity, countryDuties
Castor EDC
ORL-000011984
 Amsterdam, Netherlands Other
Kairos
ORL-000000063
 Bochum, Germany E-data capture
Ludwig Maximilian University Of Munich
ORG-100028102
 Munich, Germany Other
Fraunhofer-Institut für Algorithmen und Wissenschaftliches
ORL-000000325
 Sankt Augustin, Germany E-data capture

Locations

4 EU/EEA countries · 12 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Authorised, recruitment pending 25 1
Germany Ongoing, recruiting 175 6
Italy Ongoing, recruiting 100 4
Spain Authorised, recruitment pending 10 1
Rest of world
Australia, Israel, United Kingdom
 — 108 —

Investigational sites

Austria

1 site · Authorised, recruitment pending
Medizinische Universitaet Innsbruck
Universitätsklinik für Psychiatrie I, Anichstrasse 35, 6020, Innsbruck

Germany

6 sites · Ongoing, recruiting
Westfaelische Wilhelms-Universitaet Muenster
Klinik für Psychische Gesundheit, Gebaeude A3, Albert-Schweitzer-Campus 1, Muenster
University Hospital Frankfurt am Main
Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Heinrich-Hoffmann-Strasse 10, 60528, Frankfurt am Main
Universitätsklinik für Psychiatrie und Psychotherapie Bielefeld
Psychiatrie und Psychotherapy, Remterweg 69/71, 33617, Bielefeld
Bezirkskliniken Schwaben KU Anstalt des offentlichen Rechts des Bezirks Schwaben
Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Geschwister-Schoenert-Strasse 1, Kriegshaber, Augsburg
Klinik für Psychiatrie und Psychotherapie der Universitätsmedizin Mainz
Klinik für Psychiatrie und Psychotherapie der Universitätsmedizin Mainz, Untere Zahlbacher Strasse 8, 55131, Mainz
Lwl-Klinik Dortmund
Psychiatry, Marsbruchstrasse 179, Aplerbeck, Dortmund

Italy

4 sites · Ongoing, recruiting
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Dipartimento di Neuroscienze, Sezione di Psichiatria, Via Cherasco 15, 10126, Turin
Clinica Psichiatrica, 1st floor
Clinica Psichiatrica, 1st floor, Via Romagna 16, 09127, Cagliari
Università degli studi della Campania Luigi Vanvitelli
Dipartemento di salute mentale e fisica e medicina preventiva, Largo Madonna delle Grazie 1, 80138, Naples
University Of Brescia
Department of Mental Health and Addiction Services, Piazza Del Mercato 15, 25121, Brescia

Spain

1 site · Authorised, recruitment pending
Hospital Clinic of Barcelona
Department of Psychiatry and Psychology, Neuroscience Institute, Villarroel 170, Department of Psychiatry and Psychology, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2024-08-01 2024-08-01
Italy 2024-10-22 2024-10-22

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 100 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Research Protocol_2023-506602-39-00 1.3
Recruitment arrangements (for publication) K1_Recruitment arrangements website text_07_Mainz 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_02_Innsbruck 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_14_Barcelona 1.2
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Germany 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_Italy 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Poster_08 Munster NA
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Poster2 NA
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Site list Germany 3.0
Recruitment arrangements (for publication) K2_Recruitment material poster_02_Innsbruck 1
Recruitment arrangements (for publication) K2_Recruitment Material_Flyer_08_Munster 1
Recruitment arrangements (for publication) K2_Recruitment material_Poster_14_Barcelona 1.2
Recruitment arrangements (for publication) K2_Recruitment Material_Poster_Germany_22June2023_SZ 1
Recruitment arrangements (for publication) K2_Recruitment Material_Poster_Italy 1
Subject information and informed consent form (for publication) L1_ICF and SFF General_CL_redacted 1.3
Subject information and informed consent form (for publication) L1_ICF and SFF General_TC_redacted 1.3
Subject information and informed consent form (for publication) L1_ICF and SIS_privacygenetics _TC 1.2
Subject information and informed consent form (for publication) L1_ICF and SIS_privacygenetics_ TC_redacted 1.2
Subject information and informed consent form (for publication) L1_ICF and SIS_privacygenetics_CL_redacted 1.2
Subject information and informed consent form (for publication) L1_ICF and SSF_privacy _TC 1.2
Subject information and informed consent form (for publication) L1_ICF and SSF_privacy_ TC_redacted 1.2
Subject information and informed consent form (for publication) L1_ICF and SSF_privacy_CL_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF biobanking _TC 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF biobanking_ TC_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF biobanking_CL_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_02_Innsbruck_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_14_Barcelona 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Germany_redacted 1.4
Subject information and informed consent form (for publication) L1_SIS and ICF_Germany_TC_redacted 1.4
Subject information and informed consent form (for publication) L1_SIS and ICF_redact_TC 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_TC 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF_withTC_redacted 1.2
Subject information and informed consent form (for publication) L2_Other information material_GP letter_CL_redacted 1.3
Subject information and informed consent form (for publication) L2_Other information material_GP letter_TC_redacted 1.3
Subject information and informed consent form (for publication) L2_Other subject information material patient card_02_Innsbruck 1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient card_14_Barcelona 1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient card_Germany 1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient card_Italy 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Amisulpride_Austrian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Amisulpride_German NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Amisulpride_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Amisulpride_Spanish N
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Aripiprazole_English NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Asenapine_English NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Brexpiprazole_English NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Cariprazine_English NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Chlorpromazine_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Chlorpromazine_Spanish NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Clotiapine_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Clotiapine_Spanish NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Clozapine 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Clozapine_Austrian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Clozapine_German NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Clozapine_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Clozapine_Spanish NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Flupentixol_Austrian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Flupentixol_German NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Fluphenazine_German 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Haloperidol_Austrian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Haloperidol_German NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Haloperidol_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Haloperidol_Spanish 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Levomepromazine_Austrian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Levomepromazine_German NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Levomepromazine_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Levomepromazine_Spanish 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Lurasidone_English NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Olanzapine_English NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Paliperidone_English NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Perphenazine_German NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Perphenazine_Italy NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Promazine_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Quetiapine_Austrian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Quetiapine_German NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Quetiapine_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Quetiapine_Spanish NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC risperidone_Austrian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC risperidone_German NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC risperidone_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC risperidone_Spanish 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Sertindole_Austrian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Sertindole_German NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Sertindole_Spanish NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Sulpiride_Austrian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Sulpiride_German NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Sulpiride_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Sulpiride_Spanish NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ziprasidone_Austrian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ziprasidone_German NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ziprasidone_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Ziprasidone_Spanish NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Zuclopenthixol_Austrian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Zuclopenthixol_Germany NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Zuclopenthixol_Italian NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Zuclopenthixol_Spanish NA
Synopsis of the protocol (for publication) D1_Synopsis_AT_2023-506602-39-00 1.3
Synopsis of the protocol (for publication) D1_Synopsis_DE_2023-506602-39-00 1.3
Synopsis of the protocol (for publication) D1_Synopsis_English_2023-506602-39-00 1.3
Synopsis of the protocol (for publication) D1_Synopsis_ES_2023-506602-39-00 1.3
Synopsis of the protocol (for publication) D1_Synopsis_IT_2023-506602-39-00 1.3

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-08-25 Austria Acceptable
2023-12-18
 2023-12-20
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-03-28 Acceptable
2023-12-18
 2024-03-28
3 SUBSTANTIAL MODIFICATION SM-1 2024-05-24 Acceptable 2024-08-26
4 SUBSTANTIAL MODIFICATION SM-2 2024-11-08 Austria Acceptable
2025-01-27
 2025-01-29
5 SUBSTANTIAL MODIFICATION SM-4 2025-10-10 Austria Acceptable
2026-01-26
 2026-01-28
6 SUBSTANTIAL MODIFICATION SM-5 2026-02-26 Acceptable 2026-05-25

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