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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Icalcaprant Dose A 		Participants will receive oral Icalcaprant dose A once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
  • Drug: Icalcaprant
    Oral Capsules
Experimental
Icalcaprant Dose B 		Participants will receive oral Icalcaprant dose B once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
  • Drug: Icalcaprant
    Oral Capsules
Placebo Comparator
Placebo for Icalcaprant 		Participants will receive oral placebo once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
  • Drug: Placebo for Icalcaprant
    Oral Capsules

Recruiting Locations

Preferred Research Partner, Inc /ID# 279206
Little Rock 4119403, Arkansas 4099753 72211

Woodland International Research Group /ID# 277605
Little Rock 4119403, Arkansas 4099753 72211

Advanced Research Center /ID# 277537
Anaheim 5323810, California 5332921 92805

Sun Valley Research Center /ID# 277513
Imperial 5359052, California 5332921 92251

Synergy San Diego /ID# 277553
Lemon Grove 5365893, California 5332921 91945

CenExel CNR /ID# 277533
Sherman Oaks 5395244, California 5332921 91403

Inland Psychiatric Medical Group Inc. /ID# 279275
Temecula 5401395, California 5332921 92591

Sunwise Clinical Research /ID# 277555
Walnut Creek 5406990, California 5332921 94596

CenExcel Clinical Research - Main Facility /ID# 278200
Hollywood 4158928, Florida 4155751 33024

Cns Healthcare - Jacksonville /ID# 277658
Jacksonville 4160021, Florida 4155751 32256

GMI Florida - Central Miami Medical Institute /ID# 278218
Miami 4164138, Florida 4155751 33125

Clinical Neuroscience Solutions - Orlando - East South Street /ID# 277558
Orlando 4167147, Florida 4155751 32801

Trialmed /ID# 277601
Atlanta 4180439, Georgia 4197000 30328

Amr Conventions Research /ID# 277547
Warrenville 4915525, Illinois 4896861 60555

Redbird Research /ID# 277485
Las Vegas 5506956, Nevada 5509151 89119

Manhattan Behavioral Medicine /ID# 277910
New York 5128581, New York 5128638 10036

Sooner Clinical Research /ID# 277659
Oklahoma City 4544349, Oklahoma 4544379 73116

CNS Healthcare - Memphis /ID# 278192
Memphis 4641239, Tennessee 4662168 38119

Community Clinical Research - Austin - Cross Park Drive /ID# 277935
Austin 4671654, Texas 4736286 78754

Northwest Clinical Research Center /ID# 277484
Bellevue 5786882, Washington 5815135 98007

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.