Major Depressive DisorderPhase 2NCT07276997
A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder
A Phase 2 study testing Icalcaprant in people with Major Depressive Disorder, run by AbbVie at 33 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Icalcaprant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 33 sitesUnited States
- Study dates
- 18 Dec 2025to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 1 country. Contact the study team or a site near you to ask about taking part.
33 sites in 1 country
United States33 sites, 33 recruiting
- Recruiting
Advanced Research Center /ID# 277537
Anaheim, California, 92805
- Recruiting
Trialmed /ID# 277601
Atlanta, Georgia, 30328
- Recruiting
Austin Clinical Trial Partners /ID# 279321
Austin, Texas, 78737
- Recruiting
Community Clinical Research - Cross Park Drive /ID# 277935
Austin, Texas, 78754
- Recruiting
Quest Therapeutics of Avon /ID# 277550
Avon Lake, Ohio, 44012-1004
- Recruiting
Houston Clinical Trials - Bellaire /ID# 277551
Bellaire, Texas, 77401
- Recruiting
Northwest Clinical Research Center /ID# 277484
Bellevue, Washington, 98007
- Recruiting
Flourish Research - Great Lakes Clinical Trials /ID# 278201
Chicago, Illinois, 60640
- Recruiting
OSU Psychiatry Department /ID# 277529
Columbus, Ohio, 43210-1250
- Recruiting
Harmonex /ID# 277517
Dothan, Alabama, 36303
- Recruiting
Core Clinical Research /ID# 277518
Everett, Washington, 98201
- Recruiting
CenExel Hollywood FL /ID# 278200
Hollywood, Florida, 33024
- Recruiting
Sun Valley Research Center /ID# 277513
Imperial, California, 92251
- Recruiting
Cns Healthcare - Jacksonville /ID# 277658
Jacksonville, Florida, 32256
- Recruiting
Redbird Research /ID# 277485
Las Vegas, Nevada, 89119
- Recruiting
Synergy San Diego /ID# 277553
Lemon Grove, California, 91945
- Recruiting
Preferred Research Partners /ID# 279206
Little Rock, Arkansas, 72211
- Recruiting
Woodland International Research Group /ID# 277605
Little Rock, Arkansas, 72211
- Recruiting
Accellacare - Long Beach /ID# 279181
Long Beach, California, 90807
- Recruiting
Clinical Neuroscience Solutions /ID# 278192
Memphis, Tennessee, 38119
- Recruiting
GMI Florida - Central Miami Medical Institute /ID# 278218
Miami, Florida, 33125
- Recruiting
Ima Clinical Research - Manhattan /ID# 278212
New York, New York, 10036
- Recruiting
Manhattan Behavioral Medicine /ID# 277910
New York, New York, 10036
- Recruiting
Evergreen Clinical Trials - Norcross /ID# 279421
Norcross, Georgia, 30092
- Recruiting
Sooner Clinical Research /ID# 277659
Oklahoma City, Oklahoma, 73116
- Recruiting
Clinical Neuroscience Solutions - Orlando - East South Street /ID# 277558
Orlando, Florida, 32801
- Recruiting
Ima Clinical Research Phoenix (Alea) /ID# 277516
Phoenix, Arizona, 85012
- Recruiting
Pillar Clinical Research - Richardson /ID# 276764
Richardson, Texas, 75080
- Recruiting
EquiPath Health & Research Tampa Bay, LLC /ID# 279128
Riverview, Florida, 33578
- Recruiting
CenExel CNR /ID# 277533
Sherman Oaks, California, 91403
- Recruiting
Inland Psychiatric Medical Group /ID# 279275
Temecula, California, 92591
- Recruiting
Sunwise Clinical Research /ID# 277555
Walnut Creek, California, 94596
- Recruiting
Amr Conventions Research /ID# 277547
Warrenville, Illinois, 60555
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Icalcaprant, Placebo for Icalcaprant
- Keywords
- Major Depressive Disorder, Icalcaprant
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcalcaprantDrug
Oral Capsules
Placebo for IcalcaprantDrug
Oral Capsules
| Study group | Role | What they receive |
|---|---|---|
| Icalcaprant Dose A | Experimental | Participants will receive oral Icalcaprant dose A once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. Receives: Drug: Icalcaprant |
| Icalcaprant Dose B | Experimental | Participants will receive oral Icalcaprant dose B once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. Receives: Drug: Icalcaprant |
| Placebo for Icalcaprant | Placebo comparator | Participants will receive oral placebo once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. Receives: Drug: Placebo for Icalcaprant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Montgomery-Åsberg Depression Rating Scale (MADRS) The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are to be rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Measured: Up to approximately 6 weeks
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Measured: Up to approximately 10 weeks
Secondary outcomes (1)
Change from Baseline in Clinical Global Impression (CGIS)
Change from Baseline in Clinical Global Impression (CGIS)-The CGIS is a single-item clinician-reported measure of severity of depression. Clinicians are asked to consider their total clinical experience with Participants with major depressive disorder (MDD) and assess how severely ill the participant has been during the past 7 days. Response options range from 1 to 7: 1 = normal to 7 = very severely ill.
Measured: Up to approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start18 Dec 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276997
- Sponsor's protocol ID
- M25-987
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07276997
- Acronym / sponsor ID
- M25-987
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Icalcaprant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Icalcaprant Dose A | Experimental | Drug: IcalcaprantParticipants will receive oral Icalcaprant dose A once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
| Icalcaprant Dose B | Experimental | Drug: IcalcaprantParticipants will receive oral Icalcaprant dose B once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
| Placebo for Icalcaprant | Placebo comparator | Drug: Placebo for IcalcaprantParticipants will receive oral placebo once daily for 6 weeks and attend a follow up visit 30 days following end of treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IcalcaprantOral Capsules | Drug | Icalcaprant Dose A, Icalcaprant Dose B |
| Placebo for IcalcaprantOral Capsules | Drug | Placebo for Icalcaprant |
Primary outcome
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Time frame: Up to approximately 6 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS) The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are to be rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 10 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
1 secondary outcome
Change from Baseline in Clinical Global Impression (CGIS)
Time frame: Up to approximately 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Icalcaprant in people with Major Depressive Disorder, run by AbbVie at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. (time frame: Up to approximately 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.