Bright Light Therapy in Seasonal Affective Disorder (SAD)

NCT ID: NCT01030276

Last Updated: 2009-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-04-30

Brief Summary

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The aim of this study is to investigate the efficacy of bright light therapy in SAD. This is a placebo-controlled, double-blind randomized controlled trial (RCT).

Detailed Description

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Conditions

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Seasonal Affective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bright light

Group Type EXPERIMENTAL

Bright light therapy

Intervention Type OTHER

Bright light therapy

Inactive "placebo-light"

Group Type PLACEBO_COMPARATOR

Inactive "placebo-light"

Intervention Type OTHER

In this arm, patients will not get any bright-light therapy in a double-blind setting

Interventions

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Bright light therapy

Bright light therapy

Intervention Type OTHER

Inactive "placebo-light"

In this arm, patients will not get any bright-light therapy in a double-blind setting

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* a patient has, according to the DSM-IV-TR, a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)
* HAMD-21 (included in the SIGH-SAD) sum score is ≥ 22
* patient is over 18 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 DSM-IV Axis I disorder other than some anxiety disorder evaluated by MINI
* patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with the study treatment according to the investigator
* patient has alcohol or some other substance use dependence or misuse
* life-time suicide attempt, or any thought of suicide during the last month
* patients has some unstable somatic disorder
* patient uses some medication on regular basis
* patient uses some herbal 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 had bright light therapy during the current episode
* patient has some eye disease (patient can, however, be myopic or hyperopic)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role collaborator

ODL Terveys Oy

UNKNOWN

Sponsor Role collaborator

Valkee Oy

INDUSTRY

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Institute of Diagnostics (Radiology), University of Oulu, Box 5000, FIN-90014 University of Oulu, Finland

Locations

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Research unit, ODL Terveys Oy, Albertinkatu 18 A

Oulu, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Markku J Timonen, Prof

Role: CONTACT

Phone: +358 40 8324883

Email: [email protected]

Facility Contacts

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Markku J Timonen, Prof

Role: primary

Other Identifiers

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FI (FWA00000190) 11/2008

Identifier Type: -

Identifier Source: org_study_id