Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

Forest Laboratories231 enrolled

Overview

This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

231

Conditions

Major Depressive Disorder

Interventions

Antidepressant + placeboDRUG

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

Antidepressant + cariprazine (0.1-0.3 mg/day)DRUG

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

Antidepressant + cariprazine (1-2 mg/d)DRUG

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women, 18-65 years old * Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic features. * Previous failure to respond to adequate trials of one or two ADTs with less than 50% reduction in depressive symptoms during the present episode. Exclusion Criteria: * DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1

Locations (41)

Outcomes

Primary Outcomes

Montgomery-Asberg Depression Rating Scale (MADRS)

The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.

Time frame: Baseline (Week 8) to Week 16

Secondary Outcomes

Clinical Global Impression - Improvement (CGI-I)

The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale that, in this study, will be used to rate total improvement or worsening of mental illness starting at Visit 2 (Week 2) and taken at every visit through Visit 11 (Week 16). The patient will be rated on a scale from 1 to 7, 1 indicating that the patient is very much improved and 7 indicating that the patient is very much worse. The secondary efficacy parameter was the CGI-I total score at Week 16.

Time frame: Week 16

Data from ClinicalTrials.gov

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Forest Investigative Site 040

Phoenix, Arizona, United States

Forest Investigative Site 038

Scottsdale, Arizona, United States

Forest Investigative Site

Arcadia, California, United States

Forest Investigative Site

Encino, California, United States

Forest Investigative Site

Garden Grove, California, United States

Forest Investigative Site

Irvine, California, United States

Forest Investigative Site 013

Los Alamitos, California, United States

Forest Investigative Site 041

National City, California, United States

Forest Investigative Site

Oceanside, California, United States

Forest Investigative Site 025

Denver, Colorado, United States

...and 31 more locations