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Chronos: the Use of Chronobiological Treatment in Depression

NCT00149110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2009-08-06

No results posted yet for this study

Summary

The primary objective of the present study is to examine whether the combination of the antidepressant duloxetine and chronotherapeutic methods (including sleep deprivation, light therapy, and maintaining a regular sleep-wake rhythm) in patient with major depression, will induce an immediate improvement from depression and whether this antidepressive effect will be maintained in the long term (29 weeks). Patient will be randomised to the above mentioned treatment or to an active group receiving exercise.

Conditions

  • Major Depression

Interventions

PROCEDURE

Sleep deprivation

3 days with a normal night between

PROCEDURE

Light therapy

Daily light therapy for 29 weeks

PROCEDURE

Diurnal rhythms

Keeping the day-night cycle constant by use of educational measures

BEHAVIORAL

Exercise

Moderate intensity daily exercise for 30 minutes at least

DRUG

duloxetine

60 mg daily

DRUG

duloxetine

60 mg daily

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • The County of Frederiksborg

    collaborator UNKNOWN

  • Hillerod Hospital, Denmark

    lead OTHER

Principal Investigators

  • Klaus Martiny Martiny, MD Ph.D. · Psychiatric Research Unit, Hilleroed Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Denmark

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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 NCT00149110 on ClinicalTrials.gov