Clinical Trials of Two Non-drug Treatments for Chronic De... | NCT00006172

Studies
Clinical Trials of Two Non-drug Treatments for Chronic Depression

NCT00006172

Sponsor

New York State Psychiatric Institute

Status

Completed

Last Update Posted

Oct 1, 2014Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Mood Disorders
Depressive Disorders
Depression
Chronic Depression

Interventions

Bright light box
High-output negative ion generator
Low-output negative ion generator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH042931-02	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2000

Primary Completion Date

Jul 2003Actual

Completion Date

Feb 2004Actual

First Submitted Date

Aug 11, 2000

First Submission Date that Met QC Criteria

Aug 11, 2000

First Posted Date

Aug 14, 2000Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2014

Last Update Posted Date

Oct 1, 2014Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study investigates the potential efficacy of two nonpharmacologic treatments for nonseasonal depression, bright light exposure or high-density negative air ion exposure. Treatments are self-administered at home by the patient under close clinical supervision.

Detailed Description

Bright light exposure and high-density negative ion exposure have been designed to mimic outdoor environmental conditions and are effective in relieving symptoms of seasonal (winter) depression, but their effectiveness in treating chronic depression has not been explored.

Participants in this 10-week study will have an interview, a complete physical exam, and six one-hour appointments for progress evaluations. They will be randomly assigned to either light or high- or low-dose negative ions. Each treatment must be taken consistently for five weeks at the same time every day, after which treatment is temporarily suspended to determine whether symptoms return. Participants will then have the opportunity to try the alternate active treatment to determine which works best for them. On two occasions, participants will provide saliva samples, used to determine the level of melatonin, a hormone that becomes active at night and indicates whether a person's internal circadian clock is "in sync" with the day-night cycle or is early or late. This diagnostic test for melatonin, which is not yet readily available in medical practice, provides our research participants with unique information that can be used to optimize the timing of future treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bright light box	Active Comparator	60 min light therapy shortly after awakening	Device: Bright light box
high-output negative ion generator	Active Comparator	60 min high-density exposure shortly after awakening	Device: High-output negative ion generator
low-output negative ion generator	Placebo Comparator	60 min low-density exposure shortly after awakening	Device: Low-output negative ion generator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bright light box	Device	60-min light therapy shortly after awakening	bright light box

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depression scale score	change in score relative to baseline	5 weeks

Secondary Outcomes

Measure	Description	Time Frame
pineal melatonin onset tme	change in melatonin onset phase relative to baseline	5 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of major depression
Must be able to maintain a regular sleep schedule

Exclusion Criteria:

Depression restricted to certain seasons of the year
Presence of other psychiatric disorders
Current use of psychotropic medication, except for selective serotonin reuptake inhibitors (SSRIs)
Current use of recreational drugs or supplements that may affect mood
Current medical illness or medication that may affect response to antidepressant treatment
Long-distance travel while participating in the program
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Terman	NYS Psuchiatric Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychology, Wesleyan University		Middletown	Connecticut	06459	United States
Columbia Presbyterian Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9783557	Background	Terman M, Terman JS, Ross DC. A controlled trial of timed bright light and negative air ionization for treatment of winter depression. Arch Gen Psychiatry. 1998 Oct;55(10):875-82. doi: 10.1001/archpsyc.55.10.875.
9609674	Background	Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17. doi: 10.1016/s0165-0327(98)00005-6.

ID	Term
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D019964	Mood Disorders
D003866	Depressive Disorder
D003863	Depression