A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-Severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and an Open- labeled Long-term Extension Treatment with Aticaprant

Trial details

Who runs it

Janssen Cilag International

Trial code

EU 2024-511557-21-00

Record updated

2024. november 6.

Original description

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 who have had an inadequate response to current antidepressant therapy with an SSRI or SNRIRead full original descriptionShow less

A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and an Open-label Long-term Extension Treatment with Aticaprant

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 who have had an inadequate response to current antidepressant therapy with an SSRI or SNRI

Inclusion: Adults aged 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 64 years, inclusive; Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features, based upon clinical assessment and confirmed by the SCID-CT; Moderate to severe depressive episode: MADRS ≥25 at Screening and Baseline Stable symptom severity - no clinically significant improvement (ie, >25%) between 2 the site-rater assessments; Have symptoms of anhedonia based on clinical assessment and confirmed by presence of anhedonia (positive response to MDE module symptom Item 2) on the SCID-CT at screening and have a SHAPS total score; Have had an inadequate response to at least 1 and up to 5 (inclusive) oral antidepressant treatments, administered at an adequate dose (at or above the minimum therapeutic dose per MGH ATRQ) and duration (at least 6 weeks) in the current episode of depression, including current SSRI/SNRI treatment; Be medically stable based on clinical assessment , vital signs and ECG and laboratory assessments.

Exclusion: Has one or more of the following diagnoses: 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; personality disorders (borderline, antisocial, histrionic, narcissistic); somatoform disorders A primary DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years) of: panic disorder; generalized anxiety disorder; social anxiety disorder; specific phobia (allowed as secondary diagnosis); A current (in the past year) DSM-5 diagnosis of:obsessive-compulsive disorder (OCD),post-traumatic stress disorder (PTSD),anorexia nervosa, bulimia nervosa (allowed if stable for 1 year); 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 no response (treatment failure) to 2 or more consecutive antidepressant treatments administered at an adequate dose (at or above the minimum therapeutic dose) and duration (at least 6 weeks) in the current episode of depression including the current SSRI/SNRI (ie, the one to be continued in the treatment phases) assessed using the MGH-ATRQ; Has current suicidal risk, per investigator’s clinical judgment or based on the C-SSRS.

EU CTIS 2024-511557-21-00