Skip to main content
. 2017 Jun 28;2017(6):CD009005. doi: 10.1002/14651858.CD009005.pub2

ISRCTN68824876.

Trial name or title Amisulpiride augmentation in clozapine‐unresponsive schizophrenia.
Methods Allocation: randomised.
Blindness: double‐blind.
Duration: 12 months.
Participants Diagnosis: schizophrenia.
Target sample size: 230.
History: persistent symptom severity despite adequate trial of clozapine, treatment for > 12 weeks (400 mg or more of clozapine/day), total score of 80 or greater on PANSS, CGI score of 4 or greater, SOFAS score of 40 or less. 
Age: 18‐65 years.
Interventions
  1. Combination therapy: amisulpiride + clozapine.

  2. Monotherapy: placebo + clozapine.

Outcomes
  1. Clinical response: not clinical improved (20% reduction in total PANSS score).

  2. Mental state: PANSS negative symptom sub‐scale score, CDSS. 

  3. Functioning: SOFAS. 

  4. Service use: Service engagement scale.

  5. Adverse effects: Antipsychotic side effect measures.

  6. Quality of life: Euroqol EQ‐5D.

  7. Economic: resource use data questionnaire. 

Starting date September 2010
Contact information Prof. Thomas  Barnes (t.r.barnes@imperial.ac.uk)
Centre for Mental Health 
Imperial College 
Charing Cross Campus 
St Dunstan's Road
London
W6 8RP
Notes ISRCTN trial registration ID: ISRCTN68824876
Sponsor: Imperial College London (UK)