Clozapine for Treatment-Resistant Bipolar Disorder: A Pilot Randomised Controlled Trial
A Phase II pilot randomised controlled trial
THE RATIONALE
Why this study?
Bipolar disorder can be severe, and for many people symptoms continue despite standard treatment. Clozapine is widely used for treatment-resistant schizophrenia and is recommended in some guidelines for treatment-resistant bipolar disorder. It has never been tested against a placebo in this group. This pilot study will find out whether a larger trial is practical and whether clozapine can be given safely and tolerably alongside a mood stabiliser.
THE STUDY
Study at a glance
Phase II pilot, randomised, double-blind, placebo-controlled
Adults aged 18–65 with bipolar I disorder who have not responded adequately to standard treatment and are still experiencing symptoms
Two psychiatric centres in Pakistan (Karachi and Hyderabad)
40 participants, with 20 receiving clozapine and 20 receiving placebo
Clozapine or an identical-looking placebo, added to each participant’s usual mood stabiliser, with the clozapine dose increased gradually
12 weeks of treatment with weekly assessments
How easy the study is to run (recruitment, retention, adherence), safety and tolerability, and early signs of change in mood, anxiety, suicidal thoughts and daily functioning
Participant allocation
40 participants in two groups - 20 clozapine & 20 placebo
Study overview
Gradual clozapine dose increase -> Weekly assessments -> 12-week treatment period
PARTICIPANT MONITORING
Keeping participants safe
Participants are monitored closely, with regular blood tests, heart checks, side-effect reviews and suicide-risk assessments. An independent committee oversees safety throughout the study.
Regular blood tests
Heart checks
Side-effect reviews
Suicide-risk assessments
Independent committee oversight