A Two-Part Study of CLE-100 as an Adjunct Therapy in Subjects With Major Depressive Disorder
Overview
- Phase
- Phase 2
- Intervention
- CLE-100
- Conditions
- Adjunctive Treatment of Major Depressive Disorder
- Sponsor
- Clexio Biosciences Ltd.
- Enrollment
- 146
- Locations
- 46
- Primary Endpoint
- Part B - Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief 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.
Detailed Description
CLEO study is performed in two parts (part A and Part B). Part A will be an inpatient study to assess the safety, tolerability, and pharmacokinetics of CLE-100 (oral esketamine) in MDD participants currently treated with an antidepressant drug. It will include a screening phase (up to 35 days), a 1 week inpatient double-blind treatment phase and an outpatient post treatment safety follow-up phase of 1 week after last study drug administration. Part B will be a study to assess the safety and efficacy of CLE-100 (oral esketamine) in MDD participants currently treated with an antidepressant drug with inadequate response to standard antidepressant therapy. The participants will remain on their current antidepressant therapy with no dose change during the study.
Investigators
Eligibility Criteria
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
- •Part B - Inclusion Criteria:
- •Male or female between 18 to 65 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 24 at Screening.
- •At least 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
Arms & Interventions
Part A - CLE-100 (oral esketamine)
Part A: 1 oral tablet of CLE-100 once daily for 1 week.
Intervention: CLE-100
Part A - Placebo
Part A: 1 oral tablet of Placebo once daily for 1 week.
Intervention: placebo
Part B - CLE-100 (oral esketamine)
Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.
Intervention: CLE-100
Part B - Placebo
Part B: 1 oral tablet of Placebo once daily for 4 weeks.
Intervention: placebo
Outcomes
Primary Outcomes
Part B - Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
Time Frame: 29 days
The MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.