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

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

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

Study Overview

• Status: Completed
• Conditions: Seasonal Affective Disorder
• Intervention / Treatment: Other: Light Therapy; Other: Placebo Light

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Department of Psychiatry and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Other Outcome Measures

Outcome Measure	Time Frame
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)
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)
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)
Light exposition assessed with photometer	During the 3 weeks of light therapy (between PET1 and PET2), 3 weeks before PET3
Difference in MAO-A specific distribution volume (MAO-A DVs) assessed with PET between patients and healthy controls	At PET1, PET2, and PET3

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Rupert Lanzenberger, MD, PD, A/Prof., Medical University of Vienna, Department of Psychiatry and Psychotherapy

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): April 3, 2017
• Study Completion (Actual): April 3, 2017

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Depressive Disorder; Mood Disorders; Seasonal Affective Disorder
• Other Study ID Numbers: 248/2011