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Immunological Parameters and Functional Magnetic Resonance Imaging in Seasonal Affective Disorder

Immunological Parameters and Functional Magnetic Resonance Imaging in Seasonal Affective Disorder - Immunology and fMRI in SAD

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024756
Enrollment
80
Registered
2021-03-11
Start date
2022-10-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder according to DSM-5 Healthy volunteers

Interventions

Group 1: 20 SAD patients
study medication: N-3 PUFA, specifically: eicosapentaenoic acid (EPA) 1.5g and docosahexaenoic acid (DHA) 0.5g per day as capsules as oral treatment for 8 weeks Group 2: 20 SAD patients
study medication: placebo capsules as oral treatment for 8 weeks Group 3: 20 healthy controls
study medication: N-3 PUFA, specifically: eicosapentaenoic acid (EPA) 1.5g and docosahexaenoic acid (DHA) 0.5g per day as capsules as oral treatment for 8 weeks Group 4: 20 healthy controls
study medication: placebo capsules as oral treatment for 8 weeks

Sponsors

Medizinische Universität Wien
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for SAD patients 1. Age 20 to 55 years; 2. DSM-5 diagnosis of recurrent major depressive disorder with current depressive episode with seasonal pattern specifier (current seasonal depressive episode) established by diagnostic interview according to the SCID; 3. Global Seasonality Score = 10 on the Seasonal Pattern Assessment Questionnaire (SPAQ); 4. SIGH-SAD score of =20 at screening visit; 5. Somatic health based on history, physical examination, ECG, and laboratory screening; 6. No treatment of SAD in the last 6 months (especially antidepressants and light therapy); 7. Willingness and competence to complete the informed consent process. Inclusion criteria for healthy controls (matching regarding age and sex with SAD) 1. Age 20 to 55 years; 2. Somatic and psychiatric health based on history, physical examination, ECG, laboratory screening, SCID; 3. Willingness and competence to complete the informed consent process.

Exclusion criteria

Exclusion criteria: Exclusion criteria for SAD and HC 1. Present psychiatric disorders; 2. Suicidal ideations (corresponding to a score of =3 on the SIGH-SAD); 3. Major (unstable) medical or neurological illness; 4. Disallowed concomitant medication (see chapter 5.4) during the last 6 months; 5. Intake of nutritional supplements containing n-3 PUFA; 6. Bright light therapy (as antidepressant treatment) within the last 6 months; 7. 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-5; 8. Failure to comply with the study protocol or follow the instructions of the investigators; 9. Positive urine pregnancy test.

Design outcomes

Primary

MeasureTime frame
Whole brain functional connectivity (measured by fMRI)

Secondary

MeasureTime frame
Interleukin-6, tumor nekrosis factor alpha

Countries

Austria

Contacts

Public ContactDietmar Winkler

Medizinische Universität Wien

dietmar.winkler@meduniwien.ac.at+43 1 40400 35470

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026