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Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD) (SAD3)

Primary Purpose

Seasonal Affective Disorder (SAD)

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Transcranial bright light therapy

Transcranial placebo treatment

About this trial

This is an interventional treatment trial for Seasonal Affective Disorder (SAD)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patient has (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision [DSM-IV-TR]) a Major depression, recurrent episode, seasonal pattern
Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version (SIGH-SAD-SR) score ≥ 16
patient is over 18 years and under 66 years
patient can read and understand the subject information sheet
patient has signed the informed consent form
patient is not pregnant

Exclusion Criteria:

patient has a lifetime psychotic disorder
patient has a bipolar disorder
patient has alcohol or some other substance use dependence or misuse
patient has some unstable somatic disorder
patient uses some psychotropic agencies
patient is, in the opinion of the investigator, unsuitable for any reason
patient is a member of the site personnel or their immediate families
patient has administered bright light therapy via ear canals during the current episode

Sites / Locations

Oulu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Transcranial bright light therapy

Transcranial placebo treatment

Arm Description

Outcomes

Primary Outcome Measures

Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version, total score ≤9

Remission, i.e., Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version total score ≤ 9

Secondary Outcome Measures

Beck Depression Inventory-II, total score <=10

Remission, i.e.,Beck Depression Inventory-II, total score <=10

State Trait Anxiety Inventory -Y2, total score

Trail- making test (TMT-A and TMT-B),total time

Full Information

NCT ID

NCT01784705

First Posted

February 4, 2013

Last Updated

June 27, 2013

Sponsor

University of Oulu

1. Study Identification

Unique Protocol Identification Number

NCT01784705

Brief Title

Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)

Acronym

SAD3

Official Title

Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)- a Randomized Placebo-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Oulu

4. Oversight

5. Study Description

Brief Summary

Bright light therapy (BLT) has been found to be effective in treatment of seasonal affective disorder (SAD). The mechanism of action of conventional BLT in the treatment of SAD is under debate. Recently, transcranial bright light (TBL) via ear canals has been proved to modulate the neural networks of the human brain and improve cognitive performance in healthy subjects. Moreover, TBL has been found to alleviate symptoms of SAD in open trial. In this case the investigators will study the effect of transcranial bright light treatment via ear canals on depressive and anxiety symptoms in patients suffering from SAD in randomized controlled double-blind study design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Affective Disorder (SAD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transcranial bright light therapy

Arm Type

Experimental

Arm Title

Transcranial placebo treatment

Arm Type

Placebo Comparator

Intervention Type

Device

Intervention Name(s)

Transcranial bright light therapy

Intervention Description

The bright light treatment was given transcranially via ear canals by using bright light device. The bright light was produced using two light-emitting diodes (LEDs). The bright light was transmitted into both ear canals by an optical fibre. Daily 12 minutes TBL was taken at home during forenoon.

Intervention Type

Device

Intervention Name(s)

Transcranial placebo treatment

Intervention Description

The placebo treatment was given transcranially via ear canals by placebo device. Daily 12 minutes placebo treatment was taken at home during forenoon.

Primary Outcome Measure Information:

Title

Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version, total score ≤9

Description

Remission, i.e., Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version total score ≤ 9

Time Frame

At the end of the four week study period

Secondary Outcome Measure Information:

Title

Beck Depression Inventory-II, total score <=10

Description

Remission, i.e.,Beck Depression Inventory-II, total score <=10

Time Frame

At the end of the four week study period

Title

State Trait Anxiety Inventory -Y2, total score

Time Frame

At the end of the four week study period

Title

Trail- making test (TMT-A and TMT-B),total time

Time Frame

At the end of the four weeks study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patient has (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision [DSM-IV-TR]) a Major depression, recurrent episode, seasonal pattern Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version (SIGH-SAD-SR) score ≥ 16 patient is over 18 years and under 66 years patient can read and understand the subject information sheet patient has signed the informed consent form patient is not pregnant Exclusion Criteria: patient has a lifetime psychotic disorder patient has a bipolar disorder patient has alcohol or some other substance use dependence or misuse patient has some unstable somatic disorder patient uses some psychotropic agencies patient is, in the opinion of the investigator, unsuitable for any reason patient is a member of the site personnel or their immediate families patient has administered bright light therapy via ear canals during the current episode

Facility Information:

Facility Name

Oulu University

City

Oulu

ZIP/Postal Code

Box 5000, 90014

Country

Finland

12. IPD Sharing Statement

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Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)

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