ACTIVE_NOT_RECRUITING

A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Design, Phase 2 Study to Assess the Efficacy and Safety of CLE-100 as an Adjunctive Treatment for Major Depressive Disorder Patients With Inadequate Response to Standard Antidepressants

Quick Facts

Study Start:2024-03-18
Study Completion:2026-01-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06340958

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female between 18 to 65 years of age at Screening
  2. 2. 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.
  3. 3. 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.
  4. 4. MADRS score of 24 or higher at Screening as confirmed by an independent SAFER assessor.
  5. 5. 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.
  6. 6. Able and competent to read and sign the informed consent form (ICF).
  1. 1. 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.
  2. 2. A high risk of suicide based on any of the following:
  3. 1. Item 10 of MADRS score (suicidal thoughts) is 5 or higher at Screening or Baseline.
  4. 2. Suicide attempt in the previous 6 months.
  5. 3. Significant risk, as judged by the Investigator, based on the psychiatric interview or information collected with the C SSRS at Screening or Baseline.
  6. 3. 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).
  7. 4. Use of ketamine, esketamine, PCP, or dextromethorphan recreationally in the past 6 months.
  8. 5. History or current diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder or other schizophrenia spectrum disorders.
  9. 6. Dementia, delirium, amnesia, or any other significant cognitive disorder.
  10. 7. Any medical condition for which an increase in blood pressure or intracranial pressure or intraocular pressure or tachycardia poses a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, or history of intracerebral hemorrhage).

Contacts and Locations

Study Locations (Sites)

Clinical Site 139
La Jolla, California, 92037
United States
Clinical Site 131
Lafayette, California, 94549
United States
Clinical Site 130
Upland, California, 91786
United States
Clinical Site 102
Hollywood, Florida, 33024
United States
Clinical Site 105
Lauderhill, Florida, 33319
United States
Clinical Site 140
Miami Springs, Florida, 33166
United States
Clinical Site 132
Pensacola, Florida, 32502
United States
Clinical Site 118
Atlanta, Georgia, 30030
United States
Clinical Site 138
Marietta, Georgia, 30060
United States
Clinical Site 114
Savannah, Georgia, 31405
United States
Clinical Site 127
Chicago, Illinois, 60640
United States
Clinical Site 120
Elgin, Illinois, 60123
United States
Clinical Site 108
Gaithersburg, Maryland, 20877
United States
Clinical Site 116
Flowood, Mississippi, 39232
United States
Clinical Site 126
O'Fallon, Missouri, 63368
United States
Clinical Site 101
Toms River, New Jersey, 08755
United States
Clinical Site 103
Beachwood, Ohio, 44236
United States
Clinical Site 119
North Canton, Ohio, 44720
United States
Clinical Site 135
Oklahoma City, Oklahoma, 73112
United States
Clinical Site 107
Austin, Texas, 78737
United States
Clinical Site 137
Plano, Texas, 75093
United States
Clinical Site 117
Murray, Utah, 84107
United States
Clinical Site 115
Bellevue, Washington, 98007
United States

Collaborators and Investigators

Sponsor: Clexio Biosciences Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-18
Study Completion Date2026-01-10

Study Record Updates

Study Start Date2024-03-18
Study Completion Date2026-01-10

Terms related to this study

Keywords Provided by Researchers

  • MDD, inadequate response, depression, depressive disorder, major depression, adjunct therapy, oral, esketamine

Additional Relevant MeSH Terms

  • Adjunctive Treatment of Major Depressive Disorder (MDD)