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New depression pill shows promise in early trial

NCT ID NCT04103892

Symptom relief Sponsor: Clexio Biosciences Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called CLE-100 in 146 adults with major depressive disorder who were already taking standard antidepressants. The goal was to see if adding CLE-100 could further reduce depression symptoms. Participants received either CLE-100 or a placebo, and their mood was measured using a standard depression scale.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

146 people

The number who actually took part.

Started

Sep 2019

Finished

Oct 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Part A - Inclusion Criteria: 1. Male or female between 18 to 60 years of age 2. Primary diagnosis of MDD, without psychotic features according to DSM-5 and supported by the Mini International Neuropsychiatric Interview (MINI) 3. MADRS score of at least 18 at Screening 4. Treatment with stable dose of the current antidepressant therapy for at least 4 weeks for the current major depressive episode (MDE) 5. Body mass index (BMI) between 18 and 40 kg/m2, inclusive 6. Is able and competent to read and sign the informed consent form (ICF). Part A - Exclusion Criteria: 1. History of substance use disorder per DSM-5 criteria, except for tobacco use disorder 2. History or current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorders, binge eating disorder dementia, delirium, amnesia, or any other significant cognitive disorder 3. Posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders) 4. Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk 5. Female of childbearing potential without appropriate contraceptive means, pregnant or breastfeeding Part B - Inclusion Criteria: 1. Male or female between 18 to 65 years of age 2. Primary diagnosis of MDD without psychotic features according to DSM-5 and supported by the Mini International Neuropsychiatric Interview (MINI) 3. MADRS score of at least 24 at Screening. 4. At least 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE) 5. Current MDE for at least 12 weeks 6. BMI between 18 and 40 kg/m2, inclusive. 7. Is able and competent to read and sign the ICF. Part B - Exclusion Criteria: 1. Inadequate response to more than 5 treatment courses of antidepressant medication therapy during the current MDE 2. Current MDE for longer than 5 years. 3. 3\. Has a current substance use disorder or history of any substance use disorder per DSM-5 criteria within 12 months prior to Screening, except for tobacco use disorder. 4. Has a history or current diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorders. 5. Has dementia, delirium, amnesia, or any other significant cognitive disorder. 6. Has posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders, eating disorders, etc.). 7. Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk. 8. Has been randomized in Part A of this study. 9. Is a female of childbearing potential pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adjunctive treatment of major depressive disorder

Contacts and locations

Locations

  • Clinical Site 101

    Marlton, New Jersey, 08053, United States

  • Clinical Site 102

    Staten Island, New York, 10312, United States

  • Clinical Site 103

    Boston, Massachusetts, 02114, United States

  • Clinical Site 104

    Decatur, Georgia, 30030, United States

  • Clinical Site 105

    Orlando, Florida, 32803, United States

  • Clinical Site 106

    Media, Pennsylvania, 19063, United States

  • Clinical Site 107

    Hialeah, Florida, 33016, United States

  • Clinical Site 108

    Miami Gardens, Florida, 33014, United States

  • Clinical Site 109

    Houston, Texas, 77030, United States

  • Clinical Site 110

    Las Vegas, Nevada, 89102, United States

  • Clinical Site 111

    Hickory, North Carolina, 28601, United States

  • Clinical Site 112

    Torrance, California, 90502, United States

  • Clinical Site 113

    Oceanside, California, 92056, United States

  • Clinical Site 114

    Fort Worth, Texas, 76104, United States

  • Clinical Site 115

    Bellflower, California, 90706, United States

  • Clinical Site 116

    Miami, Florida, 33145, United States

  • Clinical Site 117

    Oakland, California, 94607, United States

  • Clinical Site 118

    Philadelphia, Pennsylvania, 19104, United States

  • Clinical Site 120

    Little Rock, Arkansas, 72209, United States

  • Clinical Site 121

    Boston, Massachusetts, 02131, United States

  • Clinical Site 122

    Marietta, Georgia, 30060, United States

  • Clinical Site 123

    Riverside, California, 92506, United States

  • Clinical Site 124

    Santa Ana, California, 92705, United States

  • Clinical Site 125

    Lincoln, Nebraska, 68526, United States

  • Clinical Site 126

    Bentonville, Arkansas, 72712, United States

  • Clinical Site 127

    North Canton, Ohio, 44720, United States

  • Clinical Site 128

    New York, New York, 10036, United States

  • Clinical Site 129

    Little Rock, Arkansas, 72209, United States

  • Clinical Site 131

    Baltimore, Maryland, 21208, United States

  • Clinical Site 132

    Lafayette, California, 94549, United States

  • Clinical Site 135

    Bellevue, Washington, 98007, United States

  • Clinical Site 136

    Rockville, Maryland, 20877, United States

  • Clinical Site 137

    Orlando, Florida, 32807, United States

  • Clinical Site 138

    Middleburg Heights, Ohio, 44130, United States

  • Clinical Site 139

    St Louis, Missouri, 63128, United States

  • Clinical Site 140

    Atlanta, Georgia, 30338, United States

  • Clinical Site 141

    Anaheim, California, 92805, United States

  • Clinical Site 142

    Santa Rosa, California, 95401, United States

  • Clinical Site 143

    Raleigh, North Carolina, 27609, United States

  • Clinical Site 144

    Plano, Texas, 75093, United States

  • Clinical Site 145

    Denver, Colorado, 80209, United States

  • Clinical Site 147

    Draper, Utah, 84020, United States

  • Clinical Site 148

    Toms River, New Jersey, 08755, United States

  • Clinical Site 149

    Missouri City, Texas, 88459, United States

  • Clinical Site 150

    San Juan, 00918, Puerto Rico

  • Clinical Site 151

    Dearborn Heights, Michigan, 48034, United States