Status:
COMPLETED
Melatonin Versus Placebo for Benzodiazepine Discontinuation in Patients With Schizophrenia
Lead Sponsor:
Lone Baandrup
Collaborating Sponsors:
Glostrup University Hospital, Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, researc...
Detailed Description
Treatment of schizophrenia frequently includes prolonged administration of benzodiazepines despite lack of evidence of its use. It is often difficult to discontinue use of benzodiazepines because of d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01431092
Start Date
October 1 2011
End Date
June 1 2014
Last Update
June 6 2014
Active Locations (1)
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1
Center for Neuropsychiatric Schizophrenia Research (CNSR)/Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), University of Copenhagen, Mental Health Centre Glostrup, Mental Health Services - Capital Region of Denmark
Glostrup Municipality, Denmark, 2600