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A double blind randomized clinical trial of buprenorphine augmentation for treatment of psychotic symptoms in opioid addicted bipolar patients

Navid Khalili, MD, Abdolreza Sabahi, MD, Mostafa Vahedian, PhD, Mehdi Alimardanzadeh, MD


Objective: To assess the efficacy of buprenorphine augmentation in treatment of psychotic symptoms in bipolar disorder type I.

Design: Bipolar type I patients with manic or depressive episodes and psychotic feature and with opioid dependency comorbidity were randomly included and allocated. Both groups of buprenorphine (4 or 6 mg/d) and placebo were also treated with enough dosages of sodium valproate and risperidone. Psychosis as primary outcome and depressive and manic symptoms as secondary outcome were assessed at baseline and after 1 and 2 weeks. Data were analyzed through t test and repeated measure ANOVA.

Results: Twenty-four patients remained in each group. Both groups displayed significant reduction in psychotic, depressive, and manic symptoms during the 2 weeks of study, although there was not any significant difference between them.

Conclusions: Buprenorphine did not add any efficacy to usual treatment of psychotic episodes of bipolar, although did not aggravate psychiatric symptoms.


buprenorphine, psychosis, bipolar disorder, clinical trial

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