Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Cariprazine — DRUG
  Cariprazine supplied in capsules
• Placebo — DRUG
  Placebo supplied in capsules

Study Details

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.

Key Dates

Start date

Nov 9, 2018

Status verified

Sep 2022

Primary completion

Sep 30, 2021

Completion

Sep 30, 2021

Study Design

Enrollment

759 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cariprazine 1.5 mg/Day + ADT
  During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
• Experimental: Cariprazine 3 mg/Day + ADT
  During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).
• Placebo Comparator: Placebo + ADT
  During the double blind treatment period (6 weeks), participants will take 1 capsule of placebo, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).

Primary Outcome Measure

Total Score Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) [ Time Frame: Baseline and Week 6 ]

Locations (65)

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