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

Medical University of Vienna

Status: Completed

Conditions: Seasonal Affective Disorder

Treatments: Other: Placebo Light; Other: Light Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02582398

248/2011

Details and patient eligibility

About

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

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

99 participants in 2 patient groups, including a placebo group

Light Therapy

Experimental group

Description:

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.

Treatment:

Other: Light Therapy

Placebo Light

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Light