Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr G Boonstra

ORCID ID

Contact details

University Medical Center Utrecht
Division Brain
Department Adult Psychiatry
Housepost A.01.126
Room A.01.5.04
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 (0)30 250 7121
g.boonstra@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw: 2100.0057; NTR179

Study information

Scientific title

Prevention of iatrogenic neurological impairment in schizophrenic disorders: the Schizophrenia Termination of Pharmacotherapy (STOP) trial

Acronym

STOP trial

Study hypothesis

H0: continuation or cessation of antipsychotic therapy in psychosis free stable first episode patients with a schizophrenic disorder makes no difference with regard to relapse rates or side-effects.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Schizophrenia, schizophreniform disorder, schizoaffective disorder

Intervention

1. The patient continues with taking the antipsychotic medication according to his/her medication schedule at the day of inclusion and continues this schedule for at least 6 months
2. The patient tapers the antipsychotic medication in minimally 6 and maximally 12 weeks to zero (if possible)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Relapse, operationalised as follows:
The reappearance of psychotic symptoms:
1. As measured by an increase in the total score on the PANSS with at least 20%, and the score of 1 of the following PANSS items being more than 3: Delusions (P1), Conceptual disorganisation (P2), Hallucinations (P3) and Suspicion (P6), or
2. As expressed by the necessity (and actual fact) of an admittance for psychiatric reasons

Secondary outcome measures

1. Changes over 2 years in score on the Positive And Negative Syndrome Scale (PANSS) or subscales
2. Changes over 2 years in score on the Calgary Depression Rating Scale (CDRS)
3. Changes over 2 years in score on the Global Assessment of Functioning (GAF)
4. Changes over 2 years in score on the Clinical Global Impression scale (CGI)
5. Changes over 2 years in score on the Unified Parkinson Disease Rating Scale (UPDRS)
6. Changes over 2 years in score on the Abnormal Involuntary Movements Scale (AIMS)
7. Changes over 2 years in score on the Barnes Akathisia Rating Scale (BARS)
8. Changes over 2 years in score on the substance abuse module of the Structured Clinical Interview for DSM-IV (SCID-substance module)
9. Changes over 2 years in brain morphology as measured by structural magnetic resonance imaging (MRI) after 0, 6, 12 and 24 months
10. Changes over 2 years in score in the weight of the patient
11. Changes over 2 years in score on the compliance of the patient as measured by the Medication Adherence Rating Scale (MARS)
12. Quality of life measured at the end of the study (WHO-QOL-brief)
13. Number of life-events as measured at the end of the study (Life Events Questionnaire)
14. Quality of life and health measured by the RAND-36
15. Brain morphologic changes in time taking into account antipsychotic medication use

Overall trial start date

24/07/2002

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent obtained after oral and written explanation to the patient and its doctor
2. Aged 16 to 55 years
3. Treated for at least a year, with antipsychotics, for a first episode of schizophrenia, schizoaffective disorder of schizophreniform disorder before inclusion
4. Diagnosis code 195.10, 295.20, 295.30, 295.60, 295.70 of 295.40 according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria as assessed at inclusion with the SCID (Structured Clinical Interview for DSM-IV)
5. The patient used antipsychotics for at least 335 days during the last year
6. All of the last year the patient was in a state of clinical remission, meant is that no clear symptoms of psychosis were observed, operationalised by the lack of a score of more then 3 on the following PANSS-items (Positive And Negative Syndrome Scale): Delusions (P1), Conceptual disorganisation (P2), Hallucinations (P3) and Suspicion (P6). Possibly there were still mild rest symptoms of which the patient experienced no hinder in daily functioning.
7. No serious physical disorder
8. No psychosis during inclusion, as operationalised under item 6
9. The patient has to be able to understand and undergo the trial procedures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Judgment of the treating psychiatrist of the patient
2. The occurrence of a serious physical disease
3. Withdrawal of the informed consent of the patient
4. Death of the patient

Recruitment start date

24/07/2002

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht
Utrecht
3584 CX
Netherlands

Sponsor information

Organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Sponsor details

Laan van Nieuw Oost Indië 334
Den Haag
2593 CE
Netherlands
+31 (0)30 602 5800
info@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Eli Lilly Nederland BV (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes