Informations générales (source: ClinicalTrials.gov)
A Randomized, Double-blind, Multicenter, Parallel-group, 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 (VENTURA-2)
Interventional
Phase 3
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
décembre 2022
juillet 2025
21 décembre 2024
The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo
as adjunctive therapy to an antidepressant in improving depressive symptoms in adult
participants with major depressive disorder (MDD) with moderate to severe anhedonia
(ANH+) who have had an inadequate response to current antidepressant therapy with a
selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake
inhibitor (SNRI).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GHU PARIS PSY ET NEUROSCIENCES | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Cabinet Medical des Drs Prizac-Desbonnet Scottez - 59500 - Douai - France | Contact (sur clinicalTrials) | ||||
| CHRU de Tours Clinique Psychiatrique Universitaire - 37044 - Tours cedex 9 - France | Contact (sur clinicalTrials) | ||||
| CHU Clermont-Ferrand - Hopital Gabriel Montpied - 63000 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| CHU de Brest - Hopital de la Cavale Blanche - 29820 - Bohars - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes hotel Dieu - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Be medically stable on the basis of physical examination, medical history, vital
signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
- Have a Hamilton depression rating Scale 17 item (HDRS-17) total score of 20 or
higher at the first and second screening interviews and must not demonstrate a
clinically significant improvement (that is, an improvement of more than 20 percent
[%] on their HDRS-17 total score) between the first and the second independent
HDRS-17 assessments
- Meet Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5)
diagnostic criteria for recurrent or single episode major depressive disorder (MDD),
without psychotic features, based upon clinical assessment and confirmed by the
structural interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT).
Participants 65 years of age or older must have had the first onset of depression
prior to 55 years of age
- Is currently receiving and tolerating well any one of the following selective
serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor
(SNRI) for depressive symptoms at screening, in any approved formulation and
available in the participating country/territory: citalopram, duloxetine,
escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine,
sertraline, venlafaxine, desvenlafaxine at a stable dose (at or above the minimum
therapeutic dose per Massachusetts General Hospital Antidepressant Treatment
Response Questionnaire [MGH-ATRQ] for at least 6 weeks. The current antidepressant
cannot be the first antidepressant treatment for the first lifetime episode of
depression
- Participant's current major depressive episode, and antidepressant treatment
response in the current depressive episode, must all be confirmed by the Site
Independent Qualification Assessment
- Be medically stable on the basis of physical examination, medical history, vital
signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
- Have a Hamilton depression rating Scale 17 item (HDRS-17) total score of 20 or
higher at the first and second screening interviews and must not demonstrate a
clinically significant improvement (that is, an improvement of more than 20 percent
[%] on their HDRS-17 total score) between the first and the second independent
HDRS-17 assessments
- Meet Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5)
diagnostic criteria for recurrent or single episode major depressive disorder (MDD),
without psychotic features, based upon clinical assessment and confirmed by the
structural interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT).
Participants 65 years of age or older must have had the first onset of depression
prior to 55 years of age
- Is currently receiving and tolerating well any one of the following selective
serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor
(SNRI) for depressive symptoms at screening, in any approved formulation and
available in the participating country/territory: citalopram, duloxetine,
escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine,
sertraline, venlafaxine, desvenlafaxine at a stable dose (at or above the minimum
therapeutic dose per Massachusetts General Hospital Antidepressant Treatment
Response Questionnaire [MGH-ATRQ] for at least 6 weeks. The current antidepressant
cannot be the first antidepressant treatment for the first lifetime episode of
depression
- Participant's current major depressive episode, and antidepressant treatment
response in the current depressive episode, must all be confirmed by the Site
Independent Qualification Assessment
- Have had in the current depressive episode, no response (treatment failure) to 5 or
more antidepressant treatments including the current SSRI/SNRI (that is, the one
presumed to be continued in the treatment phase) assessed using the MGH-ATRQ
- 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 diagnostic and statistical manual of mental disorders-5th
edition (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 (that
is, at least 7 treatments), vagal nerve stimulation, or deep brain stimulation
device
- Has current, or a history (past 6 months), of seizures
- 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, per the investigator's clinical judgment or based on the
Columbia Suicide Severity Rating Scale (C-SSRS), corresponding to a response of
"Yes" on Item 4 (active suicidal ideation with some intent to act, without specific
plan) or Item 5 (active suicidal ideation with specific plan and intent), or a
history of suicidal behavior within the past 6 months prior to the start of the
Screening Phase. Participants reporting suicidal ideation with intent to act or
suicidal behavior at baseline should be excluded
- Has one or more of the following diagnoses: a) A diagnostic and statistical manual
of mental disorders-5th edition (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; b)
A current (in the past year) DSM-5 diagnosis of: obsessive-compulsive disorder
(OCD), post-traumatic stress disorder (PTSD), anorexia nervosa, bulimia nervosa; c)
A current or prior (lifetime) DSM-5 diagnosis of: a psychotic disorder or major
depressive disorder (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