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Trial record 1 of 1 for:    NCT00149110
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Chronos: the Use of Chronobiological Treatment in Depression

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ClinicalTrials.gov Identifier: NCT00149110
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : August 6, 2009
Eli Lilly and Company
The County of Frederiksborg
Information provided by:
Hillerod Hospital, Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depression Procedure: Sleep deprivation Procedure: Light therapy Procedure: Diurnal rhythms Behavioral: Exercise Drug: duloxetine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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?"
Study Start Date : September 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Hamilton score during the 29 weeks trial [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Cortisol measurements [ Time Frame: 1 week ]
  2. Depression self rating by the Preskorn scale [ Time Frame: 9 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149110

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Psychiatric Research Unit, Hilleroed Hospital
Hilleroed, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Eli Lilly and Company
The County of Frederiksborg
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Principal Investigator: Klaus Martiny Martiny, MD Ph.D. Psychiatric Research Unit, Hilleroed Hospital, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Klaus Martiny, Psychiatric Research Unit, Hillerod Hospital
ClinicalTrials.gov Identifier: NCT00149110    
Other Study ID Numbers: 2005-001855-39 Eudra CT number
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009
Keywords provided by Hillerod Hospital, Denmark:
Sleep deprivation
Light therapy
Major depression
Bipolar depression
Sleep-wake cycle
Additional relevant MeSH terms:
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Sleep Deprivation
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents