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Chronos: the Use of Chronobiological Treatment in Depression

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
The County of Frederiksborg
Information provided by:
Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT00149110
First received: September 6, 2005
Last updated: August 4, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention
Major Depression
 Procedure: Sleep deprivation
Procedure: Light therapy
Procedure: Diurnal rhythms
Behavioral: Exercise
Drug: duloxetine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "The CHRONOS Study: Can the Sleep-deprivation Induced Antidepressive Effect in Patients With Major Depression be Sustained by Correction of Diurnal Rhythms, Long Term Light Treatment and Duloxetine Treatment?"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Hamilton score during the 29 weeks trial [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cortisol measurements [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Depression self rating by the Preskorn scale [ Time Frame: 9 month ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: September 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Sleep deprivation in combination with light and duloxetine
 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
Drug: duloxetine
60 mg daily
Active Comparator: B
Exercise and duloxetine
 Behavioral: Exercise
Moderate intensity daily exercise for 30 minutes at least
Drug: duloxetine
60 mg daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of major depression according to DSM-IV
  • Patient with major depression as part of a bipolar disorder should be in adequate mood stabilizing therapy at entry to the study
  • Age of 18 or above
  • A score on the Hamilton Depression Scale, 17 items version of at least 18

Exclusion Criteria:

  • Primary psychotic disorder
  • Psychotic depression
  • Drug or alcohol abuse
  • Severe organic brain disease
  • Severe suicidal ideation (a score of 2 or above on the Hamilton Depression Scale, 17-items version)
  • Mental retardation
  • Pregnancy or lactation period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149110

Locations
Denmark
Psychiatric Research Unit, Hilleroed Hospital
Hilleroed, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Eli Lilly and Company
The County of Frederiksborg
Investigators
Principal Investigator: Klaus Martiny Martiny, MD Ph.D. Psychiatric Research Unit, Hilleroed Hospital, Denmark
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Klaus Martiny, Psychiatric Research Unit, Hillerod Hospital
ClinicalTrials.gov Identifier: NCT00149110     History of Changes
Other Study ID Numbers: 2005-001855-39 Eudra CT number
Study First Received: September 6, 2005
Last Updated: August 4, 2009
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Hillerod Hospital, Denmark:
Sleep deprivation
Exercise
Light therapy
 Major depression
Bipolar depression
Sleep-wake cycle

Additional relevant MeSH terms:
Depression
Depressive Disorder
Sleep Deprivation
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Duloxetine
Serotonin Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013