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Melatonin Versus Placebo for Benzodiazepine Discontinuation in Patients With Schizophrenia

NCT01431092 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2014-06-06

No results posted yet for this study

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.

Conditions

  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Affective Disorder

Interventions

DRUG

Placebo

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

DRUG

Melatonin

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

Sponsors & Collaborators

  • Glostrup University Hospital, Copenhagen

    collaborator OTHER

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • Lone Baandrup

    lead OTHER

Principal Investigators

  • Lone Baandrup, MD, PhD · CNSR/CINS

  • Birte Glenthøj, MD, MSc · CNSR/CINS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01431092 on ClinicalTrials.gov