Melatonin Versus Placebo for Benzodiazepine Discontinuation in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

In this trial, researchers aim to investigate if prolonged-release melatonin can facilitate the withdrawal of chronic benzodiazepine administration in patients with schizophrenia. Furthermore, researchers will investigate the association of benzodiazepine dose reduction with the following clinically important variables: sleep, psychophysiology, cognition, social function, and quality of life.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lone Baandrup
• Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research; Glostrup University Hospital, Copenhagen
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Patients diagnosed with schizophrenia, schizoaffective disorder, or bipolar affective disorder (ICD-10 criteria for schizophrenia (F20), schizoaffective disorder (F25) or bipolar affective disorder (F31) must be fulfilled at inclusion or previously as documented by chart review; fulfillment of relevant DSM-IV-TR criteria will also be registered).

• Treated with the same antipsychotic drug for at least 3 months before inclusion (change of dose, antipsychotic polypharmacy and prescription/discontinuation of add-on drugs allowed but the basic antipsychotic treatment should be the same).

• Continuously treated with at least one benzodiazepine (chlordiazepoxide, diazepam, clobazam, clonazepam, flunitrazepam, nitrazepam, bromazepam, alprazolam, lorazepam, lormetazepam, oxazepam, triazolam) or benzodiazepine related drug (zolpidem, zopiclone, zaleplon) for at least 3 months before inclusion.

• Age 18+.

• Fertile women: negative pregnancy test at baseline and use of safe contraceptives (intrauterine devices or hormonal contraception) throughout the trial period and 1 day after withdrawal of trial medication. This does not apply to sterile or infertile participants, i.e. surgically sterilized or post menopausal (missing period for at least 12 months before inclusion) women.

• Written informed consent.

Exclusion Criteria:

• Known aggressive or violent behavior.

• Mental retardation, pervasive developmental disorder, or dementia.

• Epilepsy, terminal illness, severe comorbidity or unable to understand Danish.

• Allergic to compounds in the trial medication (melatonin, lactose, starch, gelatin, talc).

• Hepatic impairment (known diagnosis).

• Pregnancy and nursing.

• Missing informed consent.