Influence of Light Exposure on Cerebral MAO-A in Seasonal Affective Disorder and Healthy Controls Measured by PET

Seasonal Affective Disorder Clinical Trial

Official title:

Influence of Light Exposure on Cerebral Monoamine Oxidase A in Seasonal Affective Disorder and Healthy Controls Measured by PET

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582398
• Other study ID #: 248/2011
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: April 3, 2017

Study information

• Verified date: May 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess differences in monoamine oxidase A (MAO-A) distribution in the brain between seasonal affective disorder patients and healthy controls using positron emission tomography. In addition the investigators aim to demonstrate the impact of light therapy on MAO-A distribution

In addition, a pilot study and a sub-study in healthy controls were performed

Description:

This study aims to assess differences in monoamine oxidase A (MAO-A) distribution in the brain between seasonal affective disorder patients and healthy controls using positron emission tomography. In addition, the investigators aim to demonstrate the impact of light therapy on MAO-A distribution by investigating patients and controls in the winter before bright light therapy, in the winter after bright-light therapy, and in the summer. Bright light therapy will be placebo controlled, randomized, and double blinded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 3, 2017
• Est. primary completion date: April 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria for Patients:

• DSM-IV diagnosis of SAD established by diagnostic interview according to the SCID.

• Global Seasonality Score of 10 or higher on the Seasonal Pattern Assessment Questionnaire (SPAQ)

• Somatic health based on history, physical examination, ECG, and laboratory screening

• Aged 18 to 55 years

• No therapeutic treatment of SAD in the last 6 months (drugs and light therapy)

• Willingness and competence to complete the informed consent process

Inclusion criteria for healthy controls:

• Aged 18 to 55 years

• Somatic and psychiatric health based on history, physical examination, ECG, laboratory screening, SCID

• Willingness and competence to complete the informed consent process

Exclusion criteria for patients and healthy controls:

• Concomitant major medical or neurological illness

• Concomitant psychiatric disorders

• Current smoking

• Ingestion of antidepressants or other psychotropic agents targeting the serotonergic system, within the last 6 months.

• Bright light therapy within the last 6 months.

• Current substance abuse including alcohol, drugs of abuse, or any medication in a manner which is indicative of substance-related disorders (e.g. substance dependency) according to the DSM-IV.

• Failure to comply with the study protocol or follow the instructions of the investigators.

• Positive urine pregnancy test.

• For participants who participated in an earlier neuroimaging study using ionizing radiation, the total radiation exposure dose of 20 mSv over the last 10 years must not be exceeded, as specified in the legislation on radiation protection (Allg. Strahlenschutzverordnung 2010; www.ris.bka.gv.at).

Related Conditions & MeSH terms

• Disease
• Mood Disorders
• Seasonal Affective Disorder

Intervention

Other:
• Light Therapy
One subgroup of SAD patients and healthy controls respectively will receive bright light therapy using an artificial white light source (PhysioLight LD220 by DAVITA®, www.davita.de/shop/lichttherapiegeraete/lichtduschen-tageslicht/physiolight-ld-220.html) with full-spectrum 10.000lux light intensity. The treatment will be applied 30min per day at a distance of about of 50cm, preferably in the morning, during 3 weeks.
• Placebo Light
The second subgroup of the SAD patients and healthy controls will receive a non-biologically active light source (<400nm or >500nm). Here, the lamp will have largely similar shape and size as compared to the therapeutic device, but the fluorescent tube with the high light intensity will be replaced by an ordinary bulb.

Locations

Country	Name	City	State
Austria	Department of Psychiatry and Psychotherapy	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in SAD symptoms assessed with Morningness-Eveningness-Questionnaire (MEQ)		PET2 (3 weeks after PET1) compared to PET 1 (baseline), PET3 (6 months after PET1) compared to PET 1 (baseline) and PET 2 (3 weeks after PET1)
Other	Change in SAD symptoms assessed with Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS)		PET2 (3 weeks after PET1) compared to PET 1 (baseline), PET3 (6 months after PET1) compared to PET 1 (baseline) and PET 2 (3 weeks after PET1)
Other	Change in SAD symptoms assessed with Beck Depression Inventory (BDI)		PET2 (3 weeks after PET1) compared to PET 1 (baseline), PET3 (6 months after PET1) compared to PET 1 (baseline) and PET 2 (3 weeks after PET1)
Other	Light exposition assessed with photometer		During the 3 weeks of light therapy (between PET1 and PET2), 3 weeks before PET3
Other	Difference in MAO-A specific distribution volume (MAO-A DVs) assessed with PET between patients and healthy controls		At PET1, PET2, and PET3
Primary	Change in MAO-A specific distribution volume (MAO-A DVs) assessed with PET		PET2 (3 weeks after PET1) compared to PET 1 (baseline), PET3 (6 months after PET1) compared to PET 1 (baseline) and PET 2 (3 weeks after PET1)