NCT00149110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

3.5 years

First QC Date

September 6, 2005

Last Update Submit

August 4, 2009

Conditions

Major Depression

Keywords

Sleep deprivationExerciseLight therapyMajor depressionBipolar depressionSleep-wake cycle

Outcome Measures

Primary Outcomes (1)

  • Hamilton score during the 29 weeks trial

    1 week

Secondary Outcomes (2)

  • Cortisol measurements

    1 week

  • Depression self rating by the Preskorn scale

    9 month

Study Arms (2)

A

EXPERIMENTAL

Sleep deprivation in combination with light and duloxetine

Procedure: Sleep deprivationProcedure: Light therapyProcedure: Diurnal rhythmsDrug: duloxetine

B

ACTIVE COMPARATOR

Exercise and duloxetine

Behavioral: ExerciseDrug: duloxetine

Interventions

Sleep deprivationPROCEDURE

3 days with a normal night between

A
Light therapyPROCEDURE

Daily light therapy for 29 weeks

A
Diurnal rhythmsPROCEDURE

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

A
ExerciseBEHAVIORAL

Moderate intensity daily exercise for 30 minutes at least

B
duloxetineDRUG

60 mg daily

A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Research Unit, Hilleroed Hospital

Hilleroed, 3400, Denmark

Location

Related Publications (3)

  • Wirz-Justice A, Benedetti F, Berger M, Lam RW, Martiny K, Terman M, Wu JC. Chronotherapeutics (light and wake therapy) in affective disorders. Psychol Med. 2005 Jul;35(7):939-44. doi: 10.1017/s003329170500437x.

    PMID: 16045060BACKGROUND

  • Martiny K, Refsgaard E, Lund V, Lunde M, Sorensen L, Thougaard B, Lindberg L, Bech P. The day-to-day acute effect of wake therapy in patients with major depression using the HAM-D6 as primary outcome measure: results from a randomised controlled trial. PLoS One. 2013 Jun 28;8(6):e67264. doi: 10.1371/journal.pone.0067264. Print 2013.

    PMID: 23840645DERIVED

  • Martiny K, Refsgaard E, Lund V, Lunde M, Sorensen L, Thougaard B, Lindberg L, Bech P. A 9-week randomized trial comparing a chronotherapeutic intervention (wake and light therapy) to exercise in major depressive disorder patients treated with duloxetine. J Clin Psychiatry. 2012 Sep;73(9):1234-42. doi: 10.4088/JCP.11m07625.

    PMID: 23059149DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorSleep DeprivationMotor ActivityBipolar Disorder

Interventions

PhototherapyCircadian RhythmExerciseDuloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBipolar and Related Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsPeriodicityChronobiology PhenomenaPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Klaus Martiny Martiny, MD Ph.D.

    Psychiatric Research Unit, Hilleroed Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

September 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

DK(1)