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Bright Light Therapy in Seasonal Affective Disorder (SAD) (VAHAVA)

Primary Purpose

Seasonal Affective Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Bright light therapy
Inactive "placebo-light"
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Affective Disorder

Eligibility Criteria

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

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)

Sites / Locations

  • Research unit, ODL Terveys Oy, Albertinkatu 18 ARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bright light

Inactive "placebo-light"

Arm Description

Outcomes

Primary Outcome Measures

Remission as defined by the SIGH-SAD

Secondary Outcome Measures

Decrease of the severity of symptoms as assessed by SIGH-SAD, Hamilton anxiety scale, and Beck depression inventory-21

Full Information

First Posted
December 10, 2009
Last Updated
December 10, 2009
Sponsor
University of Oulu
Collaborators
Oulu University Hospital, ODL Terveys Oy, Valkee Oy, University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT01030276
Brief Title
Bright Light Therapy in Seasonal Affective Disorder (SAD)
Acronym
VAHAVA
Official Title
Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oulu
Collaborators
Oulu University Hospital, ODL Terveys Oy, Valkee Oy, University of Eastern Finland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bright light
Arm Type
Experimental
Arm Title
Inactive "placebo-light"
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Bright light therapy
Intervention Description
Bright light therapy
Intervention Type
Other
Intervention Name(s)
Inactive "placebo-light"
Intervention Description
In this arm, patients will not get any bright-light therapy in a double-blind setting
Primary Outcome Measure Information:
Title
Remission as defined by the SIGH-SAD
Time Frame
28 (visit window from 26 to 30 days) days after the inclusion day
Secondary Outcome Measure Information:
Title
Decrease of the severity of symptoms as assessed by SIGH-SAD, Hamilton anxiety scale, and Beck depression inventory-21
Time Frame
28 (visit window from 26 to 30 days) days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markku J Timonen, Prof
Phone
+358 40 8324883
Email
markku.timonen@oulu.fi
Facility Information:
Facility Name
Research unit, ODL Terveys Oy, Albertinkatu 18 A
City
Oulu
ZIP/Postal Code
FIN-90100 Oulu
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markku J Timonen, Prof
Phone
+ 358 40 8324883
Email
markku.timonen@oulu.fi

12. IPD Sharing Statement

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Bright Light Therapy in Seasonal Affective Disorder (SAD)

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