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
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