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Completed

NCT Number: NCT02582398

Influence of Light Exposure on Cerebral MAO-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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy

Vienna, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

light therapy

Other

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

Other

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.

Primary outcomes

  1. Change in MAO-A specific distribution volume (MAO-A DVs) assessed with PET

    Time frame: 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 outcomes

  1. Change in SAD symptoms assessed with Morningness-Eveningness-Questionnaire (MEQ)

    Time frame: 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)

  2. Change in SAD symptoms assessed with Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS)

    Time frame: 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)

  3. Change in SAD symptoms assessed with Beck Depression Inventory (BDI)

    Time frame: 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)

  4. Light exposition assessed with photometer

    Time frame: During the 3 weeks of light therapy (between PET1 and PET2), 3 weeks before PET3

  5. Difference in MAO-A specific distribution volume (MAO-A DVs) assessed with PET between patients and healthy controls

    Time frame: At PET1, PET2, and PET3

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2015
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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