In a double-blind trial involving acutely manic patients, clonazepam was compared to placebo, both groups receiving chlorpromazine as needed. The group receiving clonazepam showed significantly more improvement in their manic but not their psychotic symptoms compared to the placebo group. This effect was not primarily related to the sedative effects of clonazepam. Clonazepam tended to reduce the need for phenothiazine medication. Side effects related to sedation were more common to the clonazepam group. These findings are the first to indicate that clonazepam may have a specific antimanic effect over and above that of phenothiazines alone.

BackgroundEye movement desensitization and reprocessing (EMDR) is an evidenced-based treatment for posttraumatic stress disorder (PTSD). Forensic mental health services provide assessment and treatment of people with mental illness and a history of criminal offending, or those who are at risk of offending. Forensic mental health services include high, medium, and low-security inpatient settings as well as prison in-reach and community outpatient services. There is a high prevalence of PTSD in forensic settings and posttraumatic experiences can arise in people who violently offend in the context of serious mental illness (SMI). Successful treatment of PTSD may reduce the risk of relapse and improve clinical outcomes for this population. This study aims to assess the efficacy, risk of harm, and acceptability of EMDR within forensic and rehabilitation mental health services, as compared to treatment as usual (routine care).MethodsThis is a single-blind, randomized controlled trial comparing EMDR therapy to the waiting list (routine care). Adult forensic mental health service users (n = 46) with SMI and meeting the criteria for PTSD will be included in the study. Participants will be randomized after baseline assessment to either treatment as usual plus waiting list for EMDR or to treatment as usual plus EMDR. The EMDR condition comprises nine sessions, around 60 min in length delivered weekly, the first of which is a case conceptualization session. The primary outcomes are clinician and participant-rated symptoms of PTSD, and adverse events. Secondary outcomes include psychotic symptoms, social functioning, level of disability, self-esteem, depressive symptoms, post-trauma cognitions, and broad domains of complex posttraumatic difficulties. A trained assessor blinded to the treatment condition will assess outcomes at baseline, 10 weeks, and 6 months. Additionally, grounded theory qualitative methods will be used to explore participant experience of EMDR for a subset of participants.DiscussionThis study will contribute to the currently limited evidence base for EMDR for PTSD in forensic settings. It is the first randomized clinical trial to assess the efficacy, risk of harm, and acceptability of EMDR for PTSD in people with SMI in either forensic, mental health inpatient, or custodial settings.Trial registrationAustralia and New Zealand Clinical Trials Network, ACTRN12618000683235. Registered prospectively on 24 April 2018.

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