A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for M… (NCT06340958) | Clinical Trial Compass
CompletedPhase 2
A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder
United States99 participantsStarted 2024-03-18
Plain-language summary
The study is a Phase 2, double-blind, randomized, placebo-controlled study in Major Depressive Disorder (MDD) participants with an inadequate response to standard antidepressants The objective of the study is to assess CLE-100 (oral esketamine) for the treatment of MDD in participants currently treated with an oral antidepressant medication and who have an inadequate response to at least 2 antidepressants.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female between 18 to 65 years of age at Screening
✓. Diagnosis of MDD, single or recurrent, without psychotic features, in the current or previous episode(s), according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5). The diagnosis of MDD must be supported by the Mini International Neuropsychiatric Interview (MINI) Screen 7.0.2 for DSM-5.
✓. Currently experiencing a Major Depressive Episode (MDE) that began at least 12 weeks but no more than 5 years prior to Screening. The current MDE must be confirmed by the independent SAFER assessor.
✓. MADRS score of 24 or higher at Screening as confirmed by an independent SAFER assessor.
✓. At Screening, a history of inadequate response to at least 2 antidepressant medications in the current MDE. Inadequate response is defined as less than 50% improvement of depression symptoms following at least 6 weeks of treatment with a therapeutic dose and is assessed by the site using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ). Inadequate response to at least 2 antidepressant medications must be verified by documented medical or pharmacy records and confirmed by an independent SAFER assessor.
✓. Able and competent to read and sign the informed consent form (ICF).
Exclusion criteria
✕. At Screening, a history of inadequate response (as defined in inclusion criterion #5) to more than 5 antidepressant medications in the current MDE using MGH-ATRQ and confirmed by the independent SAFER assessor.
✕. A high risk of suicide based on any of the following:
What they're measuring
1
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score
. Item 10 of MADRS score (suicidal thoughts) is 5 or higher at Screening or Baseline.
✕. Suicide attempt in the previous 6 months.
✕. Significant risk, as judged by the Investigator, based on the psychiatric interview or information collected with the C SSRS at Screening or Baseline.
✕. Current or lifetime history of substance use disorder with ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3.4-methylenedioxymethamphetamine (MDMA) hallucinogen-related use disorders or has any other current substance use disorder or history within 12 months prior to Screening (Substance Use Disorder is diagnosed per DSM-5 criteria and does not include tobacco use disorder).
✕. Use of ketamine, esketamine, PCP, or dextromethorphan recreationally in the past 6 months.
✕. History or current diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder or other schizophrenia spectrum disorders.