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RecruitingPhase 2

A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder

A Phase 2, Multicenter, 6-Week, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Major Depressive Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks
  • Procedures mentioned: Pills, Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 30-day safety follow-up."
  • "The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether icalcaprant, a drug still being studied, changes depression symptoms and what side effects it causes. It is for adults with major depressive disorder who are currently having a period of depression. Participants take icalcaprant or a placebo (a pill with no active drug) daily for 6 weeks, followed by 30 days of safety checks.

Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness, irritability, not being able to focus on activities, tiredness, changes in eating habits, and aches and pains. This study will assess the changes in disease activity and adverse events of oral Icalcaprant in adult participants with major depressive disorder who are currently experiencing a major depressive episode (MDE). Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with major depressive disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to placebo treatment. Around 195 adult participant with major depressive disorder will be enrolled in approximately 35 sites in North America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 30-day safety follow-up. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have major depressive disorder confirmed by a study interview, without symptoms such as seeing or hearing things that are not there.
  • Have a body mass index (BMI), a measure based on height and weight, from 18 to 35.
  • Have a current period of depression that began at least 4 weeks before giving consent and no more than 6 months before screening.
  • Have normal results on the first visit’s physical exam, blood and other lab tests, vital signs, and ECG (a heart rhythm test), or results the study doctor judges are not a medical concern.

Who can't join

  • During the current period of depression, have tried 3 or more antidepressant treatments with no more than 25% improvement, despite taking a suitable dose for at least 6 weeks.
  • Have had an allergic reaction or strong sensitivity to any study drug ingredient or to other drugs of the same type.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participants with a diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text revision (DSM-5-TR) without psychotic features, confirmed by the Mini International Neuropsychiatric Interview (MINI) 7.0. * Body Mass Index (BMI) is ≥ 18.0 to ≤ 35.0 kg/m\^2 * Currently experiencing an major depressive episode (MDE) beginning at least 4 weeks prior to consent and not exceeding 6 months prior to Screening * Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at Visit 1 or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF. Exclusion Criteria: * Has failed (no more than 25% response on Antidepressant Treatment History Questionnaire (ATRQ)) 3 or more antidepressant treatments during the current depressive episode despite an adequate dose (per ATRQ) and duration (at least 6 weeks). * History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.

Study sites (33)

AL

AR

AZ

CA

FL

GA

IL

NV

NY

OH

OK

TN

TX

WA