Status:
COMPLETED
A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study
Lead Sponsor:
Clexio Biosciences Ltd.
Conditions:
Adjunctive Treatment of Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
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 cu...
Eligibility Criteria
Inclusion
- Part A -
- 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).
- Part A -
Exclusion
- 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)
- Current MDE for at least 12 weeks
- BMI between 18 and 40 kg/m2, inclusive.
- Is able and competent to read and sign the ICF.
- Part B -
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2022
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04103892
Start Date
September 5 2019
End Date
October 5 2022
Last Update
October 14 2025
Active Locations (46)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Site 126
Bentonville, Arkansas, United States, 72712
2
Clinical Site 120
Little Rock, Arkansas, United States, 72209
3
Clinical Site 129
Little Rock, Arkansas, United States, 72209
4
Clinical Site 141
Anaheim, California, United States, 92805