A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depres… (NCT04103892) | Clinical Trial Compass
CompletedPhase 2
A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study
United States146 participantsStarted 2019-09-05
Plain-language summary
The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major Depressive Disorder (MDD) participants currently treated with antidepressant therapy. The objective of the study is to assess CLE-100 for the treatment of MDD in participants currently treated with standard antidepressant therapy.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female between 18 to 60 years of age
✓. Primary diagnosis of MDD, without psychotic features according to DSM-5 and supported by the Mini International Neuropsychiatric Interview (MINI)
✓. MADRS score of at least 18 at Screening
✓. Treatment with stable dose of the current antidepressant therapy for at least 4 weeks for the current major depressive episode (MDE)
✓. Body mass index (BMI) between 18 and 40 kg/m2, inclusive
✓. Is able and competent to read and sign the informed consent form (ICF).
Exclusion criteria
✕. History of substance use disorder per DSM-5 criteria, except for tobacco use disorder
✕. History or current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorders, binge eating disorder dementia, delirium, amnesia, or any other significant cognitive disorder
✕. Posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders)
✕. Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk
✕. Female of childbearing potential without appropriate contraceptive means, pregnant or breastfeeding
✕
What they're measuring
1
Part B - Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score