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

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ClinicalTrials.gov Identifier: NCT02582398
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna

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


Condition or disease Intervention/treatment Phase
Seasonal Affective Disorder Other: Light Therapy Other: Placebo Light Not Applicable

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  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Light Exposure on Cerebral Monoamine Oxidase A in Seasonal Affective Disorder and Healthy Controls Measured by PET
Study Start Date : November 2013
Actual Primary Completion Date : April 3, 2017
Actual Study Completion Date : April 3, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582398


Locations
Austria
Department of Psychiatry and Psychotherapy
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Rupert Lanzenberger, MD, PD, A/Prof. Medical University of Vienna, Department of Psychiatry and Psychotherapy

Responsible Party: Rupert Lanzenberger, Assoc. Prof. PD Dr. Rupert Lanzenberger, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02582398     History of Changes
Other Study ID Numbers: 248/2011
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Disease
Mood Disorders
Seasonal Affective Disorder
Pathologic Processes
Mental Disorders
Depressive Disorder