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

U

University of Oulu

Status

Unknown

Conditions

Seasonal Affective Disorder

Treatments

Other: Bright light therapy
Other: Inactive "placebo-light"

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01030276
FI (FWA00000190) 11/2008

Details and patient eligibility

About

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).

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Bright light
Experimental group
Treatment:
Other: Bright light therapy
Inactive "placebo-light"
Placebo Comparator group
Treatment:
Other: Inactive "placebo-light"

Trial contacts and locations

1

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Central trial contact

Markku J Timonen, Prof

Data sourced from clinicaltrials.gov

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