Clinical trial to study the effect of an already authorized drug on other pathologies by administering it to people with a recent diagnosis of schizophrenia.

Start 2 Dec 2024 · Status Authorised, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)

Status Authorised, recruiting

Participants planned 37

Countries 1

Sites 1

squizophrenia

Primary objective: To assess the effectiveness of Vortioxetine vs. TAU in the treatment of cognitive impairments in early psychosis, measured by the change From Baseline to Week 24 in Brief Assessment of Cognition in Schizophrenia (BACS App) scores using the Composite Z-score Defined as the Weighted Sum of the Individu…

Key facts

Sponsor: Fundacion Para La Gestion De La Investigacion En Salud De Sevilla
Participant type: Patients
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
Trial duration: 2 Dec 2024 → ongoing
Decision date (initial): 2024-12-02
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Donations

External identifiers

EU CT number: 2024-519778-38-00
EudraCT number: 2021-001333-38

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

Primary objective: To assess the effectiveness of Vortioxetine vs. TAU in
the treatment of cognitive impairments in early psychosis, measured by
the change From Baseline to Week 24 in Brief Assessment of Cognition in
Schizophrenia (BACS App) scores using the Composite Z-score Defined
as the Weighted Sum of the Individual Patient Z-scores. [Time Frame:
Baseline, week 24, week 26 and week 50]

Secondary objectives 1

Secondary objective: To assess the effectiveness of Vortioxetine vs. TAU in the treatment of negative symptoms in early psychosis, measured by the change in Negative Symptoms severity (SANS, NSA-4 total scores) from baseline to end of trial. [Time Frame: Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50] Other objectives: - To assess the effectiveness of Vortioxetine vs. TAU in the treatment of cognitive impairments in early psychosis, measured by the change in general functioning (Global Assessment of Functioning (GAF) total score) [Time Frame: baseline, week 12, week 24, week 26, week 38 and week 50] - To assess the safety of Vortioxetine in patients with early psychosis measured through the communication of any serious adverse event evaluated for relationship with the Investigational Medicinal Product (IMP) [Time Frame: from informed consent form (ICF) signature to 52 weeks]

Conditions and MedDRA coding

squizophrenia

Version	Level	Code	Term	System organ class
20.0	LLT	10076922	Early onset schizophrenia	10037175

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Outpatient 2. Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM - SCID) diagnosis of Schizophrenia spectrum disorders. 3. Age >18-50 years old 4. Stable antipsychotic medication doses during at least 4 weeks ( all second generation antipsychotics excluding clozapine). 5. No antidepressant treatment for at least 8 weeks prior to randomization. 6. PANSS Negative subscore >14 with at least two of the items at a level >/=4 (moderate) 7. PANSS Positive subscore </=14 with not more than one of the items at a level >/=4 (moderate) 8. Hamilton Depression Rating Scale (HAMD-17) total score </=12 9. Simpson Angus Score of any item <2 10. Behaviorally Anchored Rating Scale (BARS) of any item </= 1 11. Competent and willing to sign informed consent 12. The patient, if a woman, must: agree not to try to become pregnant during the study and use adequate, highly effective contraception

Exclusion criteria 1

1. Patients taking any antidepressant and its use cannot be discontinued at least 8 weeks prior to randomization. 2. Structural brain disease (based on previous medical records) 3. Cognitive disability by history and estimated intelligence quotient (IQ) <70 (ID DSM-5 diagnosis). 4. Any serious chronic medical illnesses that may interfere with the patient's ability to comply with the study procedures or that will interfere with cognition. 5. Organic mental disorders, or mental disorders due to a general medical condition. Any neurological or neurodegenerative disorders. 6. Any current diagnosis of substance abuse or dependence. 7. Serious risk of suicide. 8. Patients with thyroid conditions. 9. Intolerance to or inefficacy of vortioxetine in the past. Patients who had failed treatment with vortioxetine were also excluded. 10. Pregnant or breastfeeding female.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Primary outcome measures: Cognitive functioning improvement assessed by the change in BACS App scores.

Investigational products

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

Test 1

Vortioxetine Hydrobromide

SCP107117256 · ATC

Active substance: Vortioxetine Hydrobromide
Substance synonyms: LU21004 HBR
Route of administration: ORAL USE
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 48 Week(s)
Authorisation status: Authorised
ATC code: N06AX26 — VORTIOXETINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 9

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 USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 13 Month(s)
Authorisation status: Authorised
ATC code: N05AX08 — RISPERIDONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pregabalin

SCP1025295 · ATC

Active substance: Pregabalin
Route of administration: ORAL USE
Max daily dose: 0.8 g gram(s)
Max total dose: 0.8 g gram(s)
Max treatment duration: 13 Month(s)
Authorisation status: Authorised
ATC code: N05AH04 — QUETIAPINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Aripiprazole

SCP106382107 · ATC

Active substance: Aripiprazole
Route of administration: ORAL USE
Max daily dose: 30 mg milligram(s)
Max total dose: 30 mg milligram(s)
Max treatment duration: 13 Month(s)
Authorisation status: Authorised
ATC code: N05AX12 — ARIPIPRAZOLE
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 USE
Max daily dose: 0.3 g gram(s)
Max total dose: 0.3 g gram(s)
Max treatment duration: 13 Month(s)
Authorisation status: Authorised
ATC code: N05AA01 — CHLORPROMAZINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ziprasidone

SCP1697872 · ATC

Active substance: Ziprasidone
Route of administration: ORAL USE
Max daily dose: 160 mg milligram(s)
Max total dose: 160 mg milligram(s)
Max treatment duration: 13 Month(s)
Authorisation status: Authorised
ATC code: N05AE04 — ZIPRASIDONE
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 USE
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 13 Month(s)
Authorisation status: Authorised
ATC code: N05AH03 — OLANZAPINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP179155 · ATC

Route of administration: ORAL USE
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 13 Month(s)
Authorisation status: Authorised
ATC code: N05AG02 — PIMOZIDE
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 USE
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 13 Month(s)
Authorisation status: Authorised
ATC code: N05AD01 — HALOPERIDOL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP190451 · ATC

Route of administration: ORAL USE
Max daily dose: 0.3 g gram(s)
Max total dose: 0.3 g gram(s)
Max treatment duration: 13 Month(s)
Authorisation status: Authorised
ATC code: N05AC02 — THIORIDAZINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Gestion De La Investigacion En Salud De Sevilla

Sponsor organisation: Fundacion Para La Gestion De La Investigacion En Salud De Sevilla
Address: Avenida De Manuel Siurot S/N
City: Sevilla
Postcode: 41013
Country: Spain

Scientific contact point

Organisation: Fundacion Para La Gestion De La Investigacion En Salud De Sevilla
Contact name: UICEC-HUVR (Clinical Trial Unit)

Public contact point

Organisation: Fundacion Para La Gestion De La Investigacion En Salud De Sevilla
Contact name: UICEC-HUVR (Clinical Trial Unit)

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Spain	Authorised, recruiting	37	1
Rest of world	—	0	—

Investigational sites

Spain

1 site · Authorised, recruiting

University Hospital Virgen Del Rocio S.L.

Psiquiatry, Avenida De Manuel Siurot S/n, 41013, Sevilla

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Spain	2024-12-02

Results and documents

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

Documents 16 files

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

Type	Title	Version
Protocol (for publication)	D1_Protocol 2024-519778-38-00	1
Protocol (for publication)	Protocol modification n1 2024-519778-38-00 tc	2.0
Protocol (for publication)	Protocol modification nr1 2024-519778-38-00	2
Recruitment arrangements (for publication)	K1_ Recruitment arrangementS	1
Subject information and informed consent form (for publication)	L1_SIS and ICF adults	1
Summary of Product Characteristics (SmPC) (for publication)	E2 Quetiapina	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC aripripazol	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Clorpromazina	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Haloperidol	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Olanzapina	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Pimizida	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Risperidona	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Tioridazina	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Vortioxetina	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Ziprasidona	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis 2024-519778-38-00	1

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-11-26	Spain	Acceptable 2024-12-02	2024-12-02
2	SUBSTANTIAL MODIFICATION	SM-1	2024-12-17	Spain	Acceptable 2025-03-06	2025-03-06