Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder (JUNIPER)

Otsuka

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Centanafadine; Drug: Placebo; Drug: Escitalopram

Study type: Interventional

Funder types: Industry

Identifiers

NCT05536414

405-201-00062

Details and patient eligibility

About

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD).

The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram.

Enrollment: 337 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male and Female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode.
• History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode.

Key Exclusion Criteria:

• Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode.
• Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, neurocognitive disorder, or personality disorder.
• Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
• Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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337 participants in 4 patient groups, including a placebo group

Centanafadine + Placebo

Experimental group

Treatment:

Drug: Placebo

Drug: Centanafadine

Centanafadine + Escitalopram

Experimental group

Treatment:

Drug: Escitalopram

Drug: Centanafadine

Escitalopram + Placebo

Active Comparator group

Treatment:

Drug: Placebo

Drug: Escitalopram

Placebo + Placebo

Placebo Comparator group

Treatment:

Drug: Placebo