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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02582398
Other study ID # 248/2011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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)
See also
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