A study to evaluate the effectiveness of aticaprant as an add on treatment in patients with depression who have not responded sufficiently to their current antidepressant.

Phase 1

Active, not recruiting

• Conditions: Major Depressive Disorder (MDD); MedDRA version: 21.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2022-000439-22-BG
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 538

Inclusion Criteria

- Male or female, aged 18 to 74 years of age, inclusive.
- Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and baseline
- Be medically stable on the basis of clinical laboratory tests performed at screening
- Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features. Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age.
- Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per MHH ATRQ) and duration (at least 6 weeks) in the current episode of depression.
- Is currently receiving and tolerating well a SSRI/SNRI for depressive symptoms at screening, at a stable dose for at least 6 weeks
- Have a HDRS-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement between the first and the second independent HDRS-17 assessments

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 430
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108

Exclusion Criteria

- Have had in the current depressive episode, no response (treatment failure) to 5 or more antidepressant treatments including the current SSRI/SNRI (ie, the one presumed to be continued in the treatment phase) assessed using the MGH ATRQ.
- Has one or more of the following diagnoses:
*A DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years)of any of the following: panic disorder, generalized anxiety disorder, social anxiety disorder, specific phobia.
* current (in the past year) DSM-5 diagnosis of: obsessive-compulsive disorder, post-traumatic stress disorder, anorexia nervosa, bulimia nervosa
* A current or prior (lifetime) DSM-5 diagnosis of: a psychotic disorder or MDD with psychotic features, bipolar or related disorders, intellectual disability, autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, narcissistic personality disorders, somatoform disorders.
- Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy.
- Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
- Has had in the current episode an inadequate response to adequate course of intravenous or intranasal ketamine or esketamine, electroconvulsive therapy (i.e, at least 7 treatments), vagal nerve stimulation, or deep brain stimulation device
- Has a current homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening phase

For full list of exclusion criteria, please refer to study protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of aticaprant 10 mg compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with MDD with moderate-to-severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with an SSRI or SNRI.;Secondary Objective: To evaluate the efficacy of adjunctive aticaprant 10 mg compared with placebo in improving anhedonia in adult participants with MDD ANH+ who have had an inadequate response to current antidepressant therapy with an SSRI or SNRI;Primary end point(s): Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score;Timepoint(s) of evaluation of this end point: Day 1, Day 15, Day 29, Day 43

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change from baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) total score.;Timepoint(s) of evaluation of this end point: Day 1, Day 15, Day 29, Day 43