search
Back to results

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

Primary Purpose

Seasonal Affective Disorder

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Light Therapy
Placebo Light
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Seasonal Affective Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Department of Psychiatry and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Light Therapy

Placebo Light

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 4, 2015
Last Updated
May 3, 2018
Sponsor
Medical University of Vienna
search

1. Study Identification

Unique Protocol Identification Number
NCT02582398
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 3, 2017 (Actual)
Study Completion Date
April 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Light Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Placebo Light
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Light Therapy
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Placebo Light
Intervention 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.
Primary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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)
Title
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)
Title
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)
Title
Light exposition assessed with photometer
Time Frame
During the 3 weeks of light therapy (between PET1 and PET2), 3 weeks before PET3
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupert Lanzenberger, MD, PD, A/Prof.
Organizational Affiliation
Medical University of Vienna, Department of Psychiatry and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy
City
Vienna
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs