Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
25
Dementia
The main objective is to determine the effectiveness of psychotropic drugs not recommended by guidelines on agitated behaviour in patients with dementia.
Key facts
- Sponsor
- Amsterdam UMC
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
- Trial duration
- 23 Jul 2025 → ongoing
- Decision date (initial)
- 2025-04-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
The main objective is to determine the effectiveness of psychotropic drugs not recommended by guidelines on agitated behaviour in patients with dementia.
Secondary objectives 1
- The secondary objective is to determine the incidence of side effects. The exploratory objective is to determine the feasibility of N-of-1 trials in nursing homes with the aim of personalised treatment.
Conditions and MedDRA coding
Dementia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Nursing home resident with dementia and agitated behaviour
- The treating physician has decided to prescribe quetiapine, olanzapine or lorazepam, in shared decision making with the patient and/or representative, independently of this trial.
Exclusion criteria 6
- A life expectancy of <4 weeks, as estimated by the physician
- Inability to swallow the study capsules, assessed by the physician
- Actual alcohol and/or drug abuse
- The agitated behaviour is too unstable, as estimated by the physician
- Insufficient mastery of Dutch language, also applies to representatives if they provide informed consent
- The agitated behaviour is only present at night
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Agitation over time measured on the Cohen Mansfield Agitation Inventory (CMAI) under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.
Secondary endpoints 3
- Agitation over time measured on the Clinical Global Impression of Severity (CGI-S) and the Clinical Global Impression of Change (CGI-C) under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.
- Frequency, severity, and burden of targeted agitated behaviour over time under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.
- The incidence and severity of side effects under psychotropic drug treatment (quetiapine, olanzapine or lorazepam) compared to placebo treatment.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
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
- 10 mg milligram(s)
- Max total dose
- 420 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
- Yes
- Modification description
- Overencapsulation to ensure blinding during the trial
SCP132543 · ATC
- Active substance
- Lorazepam
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 84 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N05BA06 — LORAZEPAM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Overencapsulation to ensure blinding during the trial
SCP1025295 · ATC
- Active substance
- Pregabalin
- 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
- N05AH04 — QUETIAPINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Overencapsulation to ensure blinding during the trial
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC
- Sponsor organisation
- Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC
- Contact name
- Eefje Sizoo
Public contact point
- Organisation
- Amsterdam UMC
- Contact name
- Eefje Sizoo
Locations
1 EU/EEA country · 25 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 100 | 25 |
| Rest of world | — | 0 | — |
Investigational sites
Zorg- en Wooncentrum De Haven
De Haven, Op de Ree 161, Netherlands, Bunschoten
Stichting Sensire
Sensire, Boterstraat 2, Netherlands, Varsseveld
Stichting Amsta
Amsta, Roetersstraat 2, Netherlands, Amsterdam
Stichting Omring
Omring, Nieuwe Steen 35, Netherlands, Hoorn
Stichting Archipel Zorggroep
Archipel, Karel de Grotelaan 415, Netherlands, Eindhoven
Stichting Vivium Zorggroep
Vivium, Botterstraat 51-55, Netherlands, Huizen
Stichting Zinzia Zorggroep
Zinzia, Kortenburg 4, Netherlands, Wageningen
Stichting Zorggroep Noorderboog
Noorderboog, Werkhorst 36, Netherlands, Meppel
Stichting de Zorgcirkel
Zorgcirkel, Wielingenstraat 2, Netherlands, Purmerend
Stichting Carint Reggeland
Carint Reggeland, Hartstralaan 100, Netherlands, Hengelo
Stichting Aafje
Aafje, Lichtenauerlaan 162-178, Netherlands, Rotterdam
Stichting Zorgcombinatie Marga Klompé
Marga Klompé, Barkenkamp 11, Netherlands, Groenlo
Zorgpartners Midden-Holland
Zorgpartners, Ronsseweg 242, Netherlands, Gouda
Stichting De Waalboog
Waalboog, Groesbeekseweg 327, Netherlands, Nijmegen
Stichting Zorgbalans
Zorgbalans, Leidsevaart 588, Netherlands, Haarlem
Stichting Humanitas
Humanitas, Achillesstraat 290, Netherlands, Rotterdam
Stichting Beweging 3.0
Beweging 3.0, Basicweg 24, Netherlands, Amersfoort
Dagelijks Leven
Dagelijks Leven, Kanaal Zuid 145, Netherlands, Apeldoorn
Stichting Woonzorggroep Samen
Samen, Jacob Ruysdaellaan 30, Netherlands, Schagen
Stichting Careaz
Careaz, Het Brook 2, Netherlands, Lichtenvoorde
Stichting Zorgspectrum
Zorgspectrum, Archimedeslaan 18a, Netherlands, Nieuwegein
Stichting Careyn
Careyn, Neckardreef 6, Netherlands, Utrecht
Carinova
Carinova, St. Jozefplein 1, Netherlands, Deventer
Land van Horne
Land van Horne, Werthaboulevard 3, Netherlands, Weert
Goudenhart
Goudenhart, Antwerpseweg 7, Netherlands, Gouda
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-07-23 | 2026-01-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-510601-29 | 7.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF deelnemer - optioneel | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Vertegenwoordiger lorazepam | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Vertegenwoordiger olanzapine | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Vertegenwoordiger quetiapine | 2 |
| Subject information and informed consent form (for publication) | L2_Information Video - Dutch | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lorazepam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Olanzapine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Quetiapine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS 2024-510601-29 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS 2024-510601-29 track changes | 2.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-06 | Netherlands | Acceptable with conditions 2025-04-07
|
2025-04-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-08 | Netherlands | Acceptable 2025-06-24
|
2025-06-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-09 | Netherlands | Acceptable 2025-12-11
|
2025-12-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-27 | Netherlands | Acceptable 2026-03-12
|
2026-03-12 |