NCT00139997

Brief Summary

The purpose is to study treatments of Seasonal Affective Disorder (SAD).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
3 countries

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
7.5 years until next milestone

Results Posted

Study results publicly available

March 6, 2013

Completed
Last Updated

March 6, 2013

Status Verified

January 1, 2013

Enrollment Period

3.6 years

First QC Date

August 29, 2005

Results QC Date

September 7, 2012

Last Update Submit

January 29, 2013

Conditions

Seasonal Affective Disorder

Keywords

Major DepressionSeasonal Affective Disorder (SAD)

Outcome Measures

Primary Outcomes (1)

  • Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version

    SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression. Calculated: SIGH SAD score at trial end x 100 / SIGH SAD score at randomization

    Week 4

Secondary Outcomes (1)

  • SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version

    Weekly following randomization

Study Arms (2)

LED phototherapy device

EXPERIMENTAL

Litebook treatment devices: LED phototherapy device, used for 30 min before 8 am

Device: Litebook treatment devices

Inactivated Negative Ion Generator

PLACEBO COMPARATOR

Equivalent exposure to inactivated negative ion generator

Device: Inactivated negative ion generator

Interventions

Litebook treatment devicesDEVICE

Litebook LED phototherapy device used for 30 min before 8 am

LED phototherapy device
Inactivated negative ion generatorDEVICE

Equivalent exposure to inactivated negative ion generator

Inactivated Negative Ion Generator

Eligibility Criteria

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

You may qualify if:

  • Subjects meet DSM-IV criteria for major depressive episodes with a seasonal pattern, winter type.

You may not qualify if:

  • Significant suicidal risk
  • Serious medical illness
  • Pregnancy
  • Other DSM-IV diagnoses
  • Taking mood altering medication
  • May not travel to a sunny destination during study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Yale University School of Medicine

New Haven, Connecticut, 06504, United States

Location

University of British Columbia

Vancouver, British Columbia, V6T 2A1, Canada

Location

Royal Ottawa Mental Health Centre, , Ontario, K1Z 7K4 Canada

Ottawa, Ontario, K1Z 7K4, Canada

Location

Douglas Hospital Research Centre

Montreal, Quebec, H4H 1R3, Canada

Location

University Medical Center Groningen

Groningen, RB, 9700, Netherlands

Location

Related Publications (1)

  • Desan PH, Weinstein AJ, Michalak EE, Tam EM, Meesters Y, Ruiter MJ, Horn E, Telner J, Iskandar H, Boivin DB, Lam RW. A controlled trial of the Litebook light-emitting diode (LED) light therapy device for treatment of Seasonal Affective Disorder (SAD). BMC Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38.

    PMID: 17683643RESULT

MeSH Terms

Conditions

Seasonal Affective DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Results Point of Contact

Title
Paul Desan, MD, PhD
Organization
Yale University
paul.desan@yale.edu
203 785 2618

Study Officials

  • Paul H. Desan, PhD, MD

    Yale New Haven Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

January 1, 2002

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

March 6, 2013

Results First Posted

March 6, 2013

Record last verified: 2013-01

Locations

NL(1)CA(3)US(1)