Dehydroepiandrosterone (DHEA) as Augmentation of Standard Antidepressants in Treatment-resistant Depression.
Sponsor: Charite University, Berlin, Germany • ClinicalTrials.gov ID: NCT07843927
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Major depressive disorder (MDD) is a major contributor to impaired health worldwide. Initial antidepressant treatment of MDD does not lead to response in up to 50 % of patients. TRD (Treatment Resistant Depression) is associated with increased rates of recurrence, mortality as well as increased treating costs compared to MDD. Treatment op-tions for TRD remain limited with lithium, quetiapine and esketamine being the only recommended and approved augmentation strategies in the EU. Dehydroepiandrosterone (DHEA), an endogenous steroid hormone, is a promising, safe and tolerable adjunctive treatment op-tion. DHEA has been meta-analytically shown to elicit antidepressant effects and to be safe both in MDD and for depressive symptoms in other medical diseases. However, previous RCTs (Randomized con-trolled trial) were small and no study has yet tested the antidepressant potential of adjunct treatment with DHEA in patients with TRD. Primary objective To determine whether add-on 100 mg/d DHEA to continued standard antidepressant medication improves depression to a greater extent than add-on placebo in subjects with treatment-resistant depression. Secondary objectives To determine whether add-on 100 mg/d DHEA to continued standard antidepressant medication improves response rates, remission rates, patients' impression of change, clinician's impression of severity and change, quality of life, social functioning and self-report depression se-verity to a greater extent than adjunct placebo in subjects with TRD. Furthermore, changes in glucose, glycosylated hemoglobin (HbA1c), total, HDL- and LDL-cholesterol, C-reactive protein (CRP), and inter-leukin-6 levels from baseline to week 6 will be determined.
Interventions
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Dehydroepiandrosterone (DHEA)
(Drug)
Dehydroepiandrosterone (DHEA) will be administered orally at a fixed dose of 100 mg/day for 6 weeks as add-on treatment to continued standard antidepressant monotherapy. Standard antidepressant medication will be continued at an unchanged dose throughout the treatment period.
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Placebo
(Drug)
Matching placebo capsules, indistinguishable from the investigational product, will be administered orally for 6 weeks as add-on treatment to continued standard antidepressant monotherapy.
Eligibility criteria
Conditions
Locations
- Charité - Universitätsmedizin Berlin, Klinik für Psychiatrie und Psychotherapie — Berlin, State of Berlin, Germany
- Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Universität Augsburg — Augsburg, Germany
- Alexianer St. Hedwig Krankenhaus, Berlin — Berlin, Germany
- Universitätsklinikum Frankfurt, Klinik für Psychiatrie, Psychosomatik und Psychotherapie, — Frankfurt, Germany
- Klinik für Psychiatrie und Psychotherapie am Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany
- Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie — Hamburg, Germany
- Universitätsklinikum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie — Leipzig, Germany
- Klinik für Psychiatrie und Psychotherapie am LMU Klinikum — München, Germany
- Helios Hanseklinikum Stralsund Klinik und Poliklinik für Psychiatrie — Stralsund, Germany
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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