Seasonal Affective DisorderNCT02582398
Influence of Light Exposure on Cerebral MAO-A in Seasonal Affective Disorder and Healthy Controls Measured by PET
A study testing Light Therapy in people with Seasonal Affective Disorder, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Affective Disorder
- What is being tested?
- Light Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2013to 3 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Light Exposure on Cerebral Monoamine Oxidase 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
Read the 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.
- Conditions
- Seasonal Affective Disorder
- Being tested
- Light Therapy, Placebo Light
- Medical subject headings
- Seasonal Affective Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light TherapyOther
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 LightOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MAO-A specific distribution volume (MAO-A DVs) assessed with PET
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startNov 2013
- Primary completion3 Apr 2017
- Study completion3 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Seasonal Affective DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Lanzenberger, Medical University of Vienna
- Investigators
- Rupert Lanzenberger, MD, PD, A/Prof., Principal investigator, Medical University of Vienna, Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582398
- Sponsor's protocol ID
- 248/2011
- Status last verified
- May 2018
- First submitted
- 4 Jun 2015
- Last updated
- 9 May 2018
- Results posted
- No
Publications
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.
PubMed 41113438Handschuh 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.
PubMed 40114401Spies 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.
PubMed 37322010Handschuh 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.
PubMed 36573644
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Light Exposure on Cerebral Monoamine Oxidase A in Seasonal Affective Disorder and Healthy Controls Measured by PET
- ClinicalTrials.gov ID
- NCT02582398
- Acronym / sponsor ID
- 248/2011
- Conditions
- Seasonal Affective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 3 Apr 2017 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light Therapy | Experimental | Other: Light TherapyOne 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 | Placebo comparator | Other: Placebo LightThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light TherapyOne 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 LightThe 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 |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Derived from this study: PubMed 41113438Schlosser 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.
- Derived from this study: PubMed 40114401Handschuh 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.
- Derived from this study: PubMed 37322010Spies 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.
- Derived from this study: PubMed 36573644Handschuh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupert Lanzenberger, MD, PD, A/Prof. principal investigator
Medical University of Vienna, Department of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Therapy in people with Seasonal Affective Disorder, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02582398, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.