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Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil

NCT00670813 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-07-20

No results posted yet for this study

Summary

The study aims to investigate whether the administration of the stimulant modafinil during a 40 hour sleep deprivation period in depressed patients can intensify the antidepressant effect of the sleep deprivation as assessed by a reduction in the Hamilton Depression score (HAMD, 6-item version). We postulate that this also correlates with a reduction of the polysomnographically assessed overall amount of sleep during this period.

Conditions

Interventions

DRUG

Modafinil (Vigil)

Oral application of 2 x 100 mg Modafinil each encapsulated in identical looking gelatine capsules at 12:00, 24:00 and again at 12:00 o' clock during the 40 h sleep deprivation period

DRUG

Placebo

Oral application of 2 x 100 mg Placebo each encapsulated in identical looking gelatine capsules at 12:00, 24:00 and again at 12:00 o' clock during the 40 h sleep deprivation period

Sponsors & Collaborators

  • Cephalon

    collaborator INDUSTRY

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Michael H Wiegand, Prof. Dr.med. Dipl. Psych. · Head of the Centre for Sleep Disorders

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Germany

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 NCT00670813 on ClinicalTrials.gov