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Dehydroepiandrosterone (DHEA) as Augmentation of Standard Antidepressants in Treatment-resistant Depression.

RecruitingPhase 3Ages 18 Years - 75 YearsAllCharite University, Berlin, Germany
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In plain words

What the trial is, and whether it could suit you

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 tr

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Patient provided written informed consent -,The patient is capable of giving consent (has sufficient knowledge of German and clearly understands the nature, significance and scope, including risks, of the medical procedure) * The patients is aged between 18 and 75 years (≥ 18 and ≤ 75) * The patient has an episode of major depression according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edi-tion) * The patient has treatment-resistant depression (TRD), defined as non-response to at least one 4-week antidepressant treatment trial (including the current treatment) in the index episode (correspond-ing to level 1 resistance to treatment failure according to the Maudsley staging method) * The patient has a Montgomery-Asberg Depression Rating Scale (MADRS) score of ≥ 20 * The patient is receiving antidepressant medication (SSRI or SNRI or tricyclic antidepressant or mirtazapine or bupropion) for at least 4 weeks, the dosage is at least at the approved minimum thera-peutic dosage and has been unchanged for at least 14 days prior to screening visit. * The patient had less than three (\<3) treatment attempts with anti-depressants in the current MDE (current treatment attempts not in-cluded). Exclusion Criteria: * Exclusion Criteria Related to psychiatric diagnosis * The patient has current clinically significant suicidal ideation with intent, corresponding to a score of 4 or 5 for ideation on the C-SSRS, or a suicidal attempt within the past 6 months, as indicated by the C-SSRS at screening visit * The patient fulfills the criteria for psychotic depression according to DSM-5 * The patient meets the criteria for schizophrenia, schizoaffective disorder or bipolar disorder in M.I.N.I according to DSM-5 * The patient meets the criteria for a dependency disorder in the M.I.N.I. for DSM-5 * The patient has dementia or moderate to severe cognitive impair-ment. Exclusion Criteria Related to IMP * The Patient is currently taking DHEA or has taken it within the last 14 days prior to screening visit. * The patients is currently taking hormone replacement therapy with sex hormones (other than contraceptives) * The patient has undiagnosed genital bleeding * The patient has untreated endometrial hyperplasia The patient has or has had sex hormone-dependent cancer (e.g. breast cancer, ovarian cancer, endometrial cancer, prostate can-cer) * The patient is allergic or has contraindication to DHEA or lactulose and cellulose * The patient has previous diagnosis of chronic kidney disease stage G3b (or higher) or GFR \< 30 ml/min. * The patient has diagnosis of prostatic hyperplasia. Exclusion Criteria Related to standard antidepressant medication (AxMP) * The Patient is taking antidepressants other than those listed as in-clusion criterion (SSRI, SNRI, tricyclic antidepressants, bupropion, mirtazapine) * The patient is taking psychotropic medication, e.g. antipsychotics, anticonvulsants, lithium or Johannis herbs. Allowed substances in-clude benzodiazepines, non-benzodiazepines (Zopiclon, Zolpidem or Eszopiclon) and antidepressants listed under inclusion criteria. * The patient is using non-selective, irreversible MAO inhibitors (e.g. tranylcypromine) or selective, reversible MAO-A inhibitors (e.g. moclobemide) or the reversible non-selective MAO inhibitor line-zolid * The patient has insulin-dependent diabetes mellitus General Safety Exclusion Criteria * The patient has an untreated and unstable general medical condi-tion (e.g. hypertension with end organ damage or hypertensive de-railment) * The patient has a medical history of liver failure and/or bilirubin above 3 times the normal range and reduced total protein * The patient is pregnant or breastfeeding. * The patient of childbearing age shows an unwillingness to use an effective contraceptive method (defined as a Pearl Index \< 1) * The patient currently has or has a history of venous thromboembo-lism (VTE) (deep vein thrombosis, pulmonary embolism) * The patient currently has or has a history of arterial thromboem-bolic disease (e.g. angina pectoris, myocardial infarction, stroke) * The patient has a thrombophilic disease (e.g. protein C, protein S or antithrombin deficiency) * The patient has porphyria * The patient has clinically significant untreated hypothyroidism * The patient has clinically significant abnormalities in the 12-lead ECG (e.g. prolongation of the QTc interval ≥ 500 ms) as performed during screening visit * The patient is a vulnerable person (defined as: persons deprived their liberty, confined to an institution by court or administrative or-der, persons that may have Insufficient power, intelligence, educa-tion, resources, strength, or other needed attributes to protect their own interests, or unable to explicitly give consent) * The patient might be dependent on representative of the sponsor, the investigator or the trial site The patient is currently participating in another interventional clini-cal trial. Laboratory Exclusion Criteria * The patient's laboratory values show clinically significant abnor-malities * The patient currently has liver disease with liver-specific levels out-side the age- and gender-specific reference intervals \[elevations of GOT or GPT above 3 times the upper normal value (ULN)\]
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What it tests

  • Dehydroepiandrosterone (DHEA)
  • Placebo
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Where

9 sites
Charité - Universitätsmedizin Berlin, Klinik für Psychiatrie und Psychotherapie
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

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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