Clinical trial NCT02582398: Influence of Light Exposure on Cerebral MAO-A in Seasonal Affective Disorder and Healthy Controls Measured by PET
Official title: Influence of Light Exposure on Cerebral Monoamine Oxidase A in Seasonal Affective Disorder and Healthy Controls Measured by PET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Affective Disorder
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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

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.

Eligibility 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).

Primary outcomes:
measure: Change in MAO-A specific distribution volume (MAO-A DVs) assessed with PET
timeFrame: 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)
Secondary outcomes:
Other outcomes:
measure: Change in SAD symptoms assessed with Morningness-Eveningness-Questionnaire (MEQ)
timeFrame: 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)
measure: Change in SAD symptoms assessed with Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS)
timeFrame: 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)
measure: Change in SAD symptoms assessed with Beck Depression Inventory (BDI)
timeFrame: 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)
measure: Light exposition assessed with photometer
timeFrame: During the 3 weeks of light therapy (between PET1 and PET2), 3 weeks before PET3
measure: Difference in MAO-A specific distribution volume (MAO-A DVs) assessed with PET between patients and healthy controls
timeFrame: At PET1, PET2, and PET3
Locations:
city: Vienna
country: Austria
facility: Department of Psychiatry and Psychotherapy
Study officials:
affiliation: Medical University of Vienna, Department of Psychiatry and Psychotherapy
name: Rupert Lanzenberger, MD, PD, A/Prof.
role: PRINCIPAL_INVESTIGATOR
References: