Status:
COMPLETED
Amisulpride Augmentation in Clozapine-unresponsive Schizophrenia
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
University of Manchester
University College, London
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Schizophrenia is a mental health problem usually starting in the late teens/early twenties, and often lasting many years. The standard medication ('antipsychotics') for this problem is usually helpful...
Detailed Description
This 12-week, placebo-controlled RCT will be conducted in secondary care, specifically mental health services, at UK centres. The health technology to be assessed is the augmentation of clozapine trea...
Eligibility Criteria
Inclusion
- A criterion level of persistent symptom severity despite an adequate trial of clozapine monotherapy in terms of dosage, duration and adherence (as used by Honer et al 2006):
- Treatment for at least 12 weeks at a stable dose of 400 mg or more of clozapine a day, unless the size of the dose was limited by side effects
- A total score of 80 or greater at baseline on the Positive and Negative Syndrome Scale (PANSS: Kay et al 1987, 1988); the range of possible scores is 30 to 210, with higher scores indicating more severe symptoms.
- A Clinical Global Impressions (CGI: Guy 1976) score of 4 or greater (range of possible scores, 1=not mentally ill to 7=extremely ill)
- A Social and Occupational Functioning Assessment Scale (SOFAS: Goldman et al 1992, DSM-IV 1994) score of 40 or less; range of possible scores, 1 to 100, with lower scores indicating impaired functioning.
- Age 18-65 years, inclusive
- Clinically stable for the last 3 months with a consistent clozapine regimen.
- Competent and willing to provide written, informed consent.
Exclusion
- Clinically-significant alcohol/substance use in the previous three months
- Developmental disability
- Indication for current treatment with clozapine was intolerance/movement disorder
- A previous trial of clozapine augmentation with amisulpride.
- Existing relevant physical health problems: such as cardiovascular disease, previous problems with prolactin, and impaired liver/ renal function.
- Any woman who is pregnant or planning a pregnancy, and any woman of child bearing potential unless using adequate contraception.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01246232
Start Date
September 1 2011
End Date
March 1 2015
Last Update
April 1 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University College London
London, United Kingdom, NW3 2PF
2
Imperial College London
London, United Kingdom, W6 8LN
3
University of Manchester
Manchester, United Kingdom, M13 9WL