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Region Hovedstaden - en del af Københavns Universitetshospital

Discontinuation of benzodiazepine treatment facilitated by melatonin in schizophrenia patients: a randomised clinical trial

Projekt: Typer af projekterProjekt

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Background and aim
Chronic benzodiazepine treatment in patients with schizophrenia is widely used despite clinical evidence-based guidelines recommending only short term therapy. Chronic benzodiazepine treatment is associated with numerous side effects, including sedation, reduced cognitive functioning, tolerance and physical and psychological dependence. In a recent Danish register-based study we furthermore found an association with increased risk of death from natural causes. Discontinuation is often difficult and no medication as yet has proven effective as an aid in the tapering process. Melatonin secretion has been shown to be reduced both in patients with schizophrenia and in patients treated with benzodiazepines. It is therefore hypothesized that melatonin can facilitate discontinuation of benzodiazepines in patients with schizophrenia. The topic has previously only been investigated in general practice with controversial results.
The aim of the study is to investigate if melatonin as augmenting therapy can facilitate discontinuation of chronic benzodiazepine use in antipsychotic treated patients with schizophrenia in stable phase. Furthermore, we investigate the effect of benzodiazepine discontinuation and melatonin augmentation on cognition, psychophysiology, sleep and quality of life.

Randomized double-blind clinical placebo-controlled trial. Patients with schizophrenia in stable phase and treated with antipsychotic(s) and benzodiazepine(s) are randomized to treatment group or control group. The benzodiazepines are slowly and gradually tapered off in all patients. The patients in the treatment group are concomitantly treated with prolonged-release melatonin (Circadin 2 mg) 1-2 hours before bedtime and the patients in the control group with identical placebo. The following investigations are done at baseline (before tapering off benzodiazepines and study treatment) and at 6 months follow up. The planned investigations include: Psychophysiological assessment, neurocognitive assessment, subjective and objective sleep evaluation, various questionnaires, assessment of functioning and psychopathology and laboratory measures.
Power calculation has indicated a total of 80 patients or 40 in each group. The clinical part of the study is expected to last approximately two years and start of inclusion of patients in autumn 2011.
The study will be conducted according to ICH-GCP guidelines and the results published in scientific international journals.
FinansieringskildeAnden offentlig støtte (Offentlig)
ForskningsprogramPost.doc. bevilling/RHP
Beløb2.145.000,00 Danske Kroner
FinansieringskildeIntern støtte (Offentlig)
ForskningsprogramRHP Forskningspulje 2012
Beløb90.000,00 Danske Kroner

ID: 32283341