NCT02582398

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2017

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

3.4 years

First QC Date

June 4, 2015

Last Update Submit

May 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Other Outcomes (5)

  • 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)

  • 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)

  • 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)

  • +2 more other outcomes

Study Arms (2)

Light Therapy

EXPERIMENTAL

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

Placebo Light

PLACEBO COMPARATOR

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

Interventions

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.

Light Therapy

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.

Placebo Light

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy

Vienna, Austria

Location

Related Publications (4)

  • Schlosser G, Murgas M, Godbersen GM, Reichel S, Silberbauer L, Nics L, Winkler D, Stimpfl T, Hacker M, Kasper S, Rujescu D, Lanzenberger R, Spies M. Human in vivo assessment of ketamine binding of the serotonin transporter-follow up at a higher dose. Front Neurosci. 2025 Oct 2;19:1651016. doi: 10.3389/fnins.2025.1651016. eCollection 2025.

  • Handschuh PA, Murgas M, Winkler D, Winkler-Pjrek E, Hartmann AM, Domschke K, Baldinger-Melich P, Rujescu D, Lanzenberger R, Spies M. Summer and SERT: Effect of daily sunshine hours on SLC6A4 promoter methylation in seasonal affective disorder. World J Biol Psychiatry. 2025 Apr;26(4):159-169. doi: 10.1080/15622975.2025.2477463. Epub 2025 Mar 20.

  • Spies M, Murgas M, Vraka C, Philippe C, Gryglewski G, Nics L, Balber T, Baldinger-Melich P, Hartmann AM, Rujescu D, Hacker M, Winkler-Pjrek E, Winkler D, Lanzenberger R. Impact of genetic variants within serotonin turnover enzymes on human cerebral monoamine oxidase A in vivo. Transl Psychiatry. 2023 Jun 15;13(1):208. doi: 10.1038/s41398-023-02506-2.

  • Handschuh PA, Murgas M, Vraka C, Nics L, Hartmann AM, Winkler-Pjrek E, Baldinger-Melich P, Wadsak W, Winkler D, Hacker M, Rujescu D, Domschke K, Lanzenberger R, Spies M. Effect of MAOA DNA Methylation on Human in Vivo Protein Expression Measured by [11C]harmine Positron Emission Tomography. Int J Neuropsychopharmacol. 2023 Feb 14;26(2):116-124. doi: 10.1093/ijnp/pyac085.

MeSH Terms

Conditions

Seasonal Affective Disorder

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Rupert Lanzenberger, MD, PD, A/Prof.

    Medical University of Vienna, Department of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr. Rupert Lanzenberger, MD

Study Record Dates

First Submitted

June 4, 2015

First Posted

October 21, 2015

Study Start

November 1, 2013

Primary Completion

April 3, 2017

Study Completion

April 3, 2017

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations