CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 86 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Melatonin 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01431092
NCT01431092Phase 4Completed
CompareCT.gov

Prolonged-release Melatonin Versus Placebo for Benzodiazepine Discontinuation in Patients With Schizophrenia: a Randomized Clinical Trial

Lone Baandrup·interventional·Posted Sep 9, 2011·Updated Jun 6, 2014

In Brief

A Phase 4 clinical trial evaluating Placebo and Melatonin for Schizophrenia and 2 related conditions. Completed, enrolled 86 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder, Bipolar Affective Disorder
CountriesDenmark
CollaboratorsGlostrup University Hospital, Copenhagen, Copenhagen Trial Unit, Center for Clinical Intervention Research

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2011
Enrollment StartOct 1, 2011
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.8 years ago

Interventions

Placebodrug

Both Circadin and placebo are encapsulated in lactose containing gelatin capsules to optimize the blinding.

Melatonindrug

Prolonged-release melatonin (Circadin®) 2 mg, once daily, 1-2 hours before bedtime.