Focusing on clozapine unresponsive symptoms trial

Not Applicable

Completed

• Conditions: Mental Health / Psychosis; Mental and Behavioural Disorders; Unspecified nonorganic psychosis

• Registration Number: ISRCTN99672552
• Lead Sponsor: Greater Manchester West Mental Health NHS Foundation Trust (UK)

Brief Summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27496180 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30806619

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-29
• Study Completion: 2017-07-31
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 487

Inclusion Criteria

Current inclusion criteria from 04/12/2012 (trial record updated 07/03/2014):
1. A criterion level of persistent symptom severity despite an adequate trial of clozapine in terms of dosage, duration and adherence (as used by Honer et al 2006):
1.1. Treatment of clozapine at a stable dose of 400mg or more (unless limited by tolerability) for at least 12 weeks, or if currently augmented with a second antipsychotic that this has been given for at least 12 weeks, without remission of psychotic symptoms, or have discontinued clozapine due to adverse reactions (including agranulocytosis) or lack of efficacy in the past 24 months
1.2. Presence of at least one psychotic symptom with severity =4 (for hallucinations/delusions) or =5 (for suspiciousness/grandiosity) on the PANSS in addition to a PANSS total score of at least 58, which is equivalent to a clinical global impression (CGI) of being at least mildly ill 51
2. Be in contact with mental health services and have a care coordinator
3. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) in order to allow for diagnostic uncertainty in early phases of psychosis
4. Aged at least 16 years old
5. Competent and willing to provide written, informed consent.

Original inclusion criteria:
1. 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 24 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, without remission of psychotic symptoms, or have discontinued clozapine due to adverse reactions (including agranulocytosis) or lack of efficacy in the past 24 months.
2. Presence of at least one psychotic symptom with severity 4 (for hallucinations/delusions) or 5 (for suspiciousness/grandiosity) on the Positive and Negative Syndrome Scale (PANSS) in addition to a PANSS total score of at least 58, which is equivalent to a Clinical Global Impression (CGI) of being at least mildly ill.
3. Be in contact with mental health services and have a care coordinator
4. Either meet ICD-10 criteria for schizophrenia, schizoaffective disorder or delusional disorder or meet entry criteria for an Early Intervention for Psychosis service (operationally defined using PANSS) in order to allow for diagnostic uncertainty in early phases of psychosis
5. Male & female aged at least 16 years old
6. Competent and willing to provide written, informed consent

Exclusion Criteria

1. Primary diagnosis of alcohol/substance dependence, where this is clearly the cause of their psychotic symptoms
2. Developmental disability
3. Non-English speaking
4. Current receipt (or within the last 12 months) of structured CBT from a qualified psychological therapist in accordance with NICE guideline recommendations (as opposed to more generic psychosocial interventions)

Study & Design

• Study Type: Interventional
• Study Design: Not specified