NCT00809523

Brief Summary

This is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase and a 4 week treatment phase.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

Geographic Reach
3 countries

8 active sites

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

December 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2.9 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

1.3 years

First QC Date

December 16, 2008

Results QC Date

September 7, 2012

Last Update Submit

January 29, 2013

Conditions

Seasonal Affective Disorder

Keywords

SADwinter depression

Outcome Measures

Primary Outcomes (1)

  • Percentage Change SIGH SAD Depression Rating

    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 - SIGH SAD score at randomization x 100 / SIGH SAD score at randomization

    4 weeks

Secondary Outcomes (2)

  • SIGH SAD Depression Rating

    Weekly

  • Clinical Global Impression of Severity

    Randomization and at 4 weeks

Study Arms (2)

Inactivated negative ion generator

EXPERIMENTAL

Equivalent exposure to inactivated Negative Ion Generator

Device: Negative Ion Generator

LED light treatment device

EXPERIMENTAL

Light-emitting photodiode light treatment device, used for 30 min before 8 am

Device: Light-emitting Photodiode light treatment device

Interventions

Negative Ion GeneratorDEVICE

Equivalent exposure to inactivated Negative Ion Generator

Inactivated negative ion generator
Light-emitting Photodiode light treatment deviceDEVICE

Light-emitting Photodiode light treatment device, used for 30 min before 8 am

LED light treatment device

Eligibility Criteria

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

You may qualify if:

  • Seasonal Affective Disorder
  • Age 18 to 65

You may not qualify if:

  • Psychotropic medication treatment
  • History of light treatment for SAD
  • History of mania or psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Yale University School of Medicine

New Haven, Connecticut, 06504, United States

Location

Capital Clinical Research Associates

Rockville, Maryland, 20852, United States

Location

McLean Hospital/Harvard

Belmont, Massachusetts, 02478, United States

Location

University of British Columbia

Vancouver, British Columbia, V6T 2A1, Canada

Location

St. John Regional Hospital

Saint John, New Brunswick, E2l 4L2, Canada

Location

CAMH/University of Toronto

Toronto, Ontario, M5T 1R8, Canada

Location

Sleep and Alertness Inc

Toronto, Ontario, Canada

Location

University Medical Center Groningen

Groningen, RB, 9700, Netherlands

Location

MeSH Terms

Conditions

Seasonal Affective Disorder

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 Desan, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Raymond Lam, MD

    University of British Columbia, Vancouver, Canada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
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

December 16, 2008

First Posted

December 17, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

March 6, 2013

Results First Posted

March 6, 2013

Record last verified: 2013-01

Locations

CA(4)US(3)NL(1)