Bright Light Therapy in Seasonal Affective Disorder (SAD)

NCT01293409 | Completed DMC

• 1 other identifier: FI (FWA00000190) 11/2008b
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Bright light therapy (BLT) is widely accepted as first-line treatment of seasonal affective disorder (SAD). However, the mechanism of action of BLT is still widely unknown. On the other hand, in mammals, light penetrates the skull bone and reaches the brain, and extra ocular transcranial phototransduction has physiological influences such as changed reproductive cycles and increased brain serotonin levels. Therefore, the investigators run a randomized, placebo controlled, double blind, dose finding study on the putative effect of transcranial bright light in the treatment of SAD.

Conditions

Seasonal Affective Disorder

Outcome Measures

Primary Outcomes (1)

• The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8

  Remission, i.e., the 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8

  At the end of the four-week study period

Secondary Outcomes (5)

• ≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD

  At the end of the four-week study period

• ≥ 50 % decrease of the severity of symptoms as assessed by the 14-item Hamilton Anxiety Rating Scale total score

  At the end of the four-week study period

• ≥ 50 % decrease of the severity of symptoms as assessed by the 21-item Beck depression Inventory (BDI-21) total score

  At the end of the four-week study period

• ≥ 50 % decrease of the severity of symptoms as assessed by 21-item Hamilton Depression Rating Scale total score

  At the end of the four-week study period

• A number of participants with bright light therapy related (according to physician decision) adverse events as a measure of safety and tolerability

  During the four week study period

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The amount of photic energy of light is considered to be non-therapeutical

Other: Transcranial Brain-Targeted Bright Light Treatment

Intermediate dose

EXPERIMENTAL

The amount of photic energy of bright light is considered to be "intermediate"

Other: Transcranial Brain-Targeted Bright Light Treatment

High dose bright light

EXPERIMENTAL

The amount of photic energy of bright light is considered to be fully therapeutic

Other: Transcranial Brain-Targeted Bright Light Treatment

Interventions

Transcranial Brain-Targeted Bright Light Treatment OTHER

Transcranial Brain-Targeted Bright Light Treatment via Ear Canals

Also known as: VALKEE

High dose bright light; Intermediate dose; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a 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, "moderate" or "severe" (classification code 296.32 and 296.33)
• The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20
• The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) score ≥ 20
• The 21-item Hamilton Depression Rating Scale score ≥ 10
• The 8-item atypical symptom score ≥ 5
• 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

You may not qualify if:

• 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
• patients 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 had bright light therapy via ear canals during the current episode

Sponsors & Collaborators

• University of Oulu: lead
• Oulu University Hospital: collaborator
• ODL Terveys Oy: collaborator
• Valkee Oy: collaborator
• University of Eastern Finland: collaborator

Study Sites (1)

ODL Terveys Oy

Oulu, 90100, Finland

Location

Related Publications (1)

• Jurvelin H, Takala T, Nissila J, Timonen M, Ruger M, Jokelainen J, Rasanen P. Transcranial bright light treatment via the ear canals in seasonal affective disorder: a randomized, double-blind dose-response study. BMC Psychiatry. 2014 Oct 21;14:288. doi: 10.1186/s12888-014-0288-6.

  PMID: 25330838 DERIVED

MeSH Terms

Conditions

Seasonal Affective Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Pirkko Räsänen, M.D., Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: February 10, 2011
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 1, 2011

Record last verified: 2011-05

Locations

FI (1)