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

NCT ID: NCT00854100

Last Updated: 2019-03-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo

Group Type PLACEBO_COMPARATOR

Antidepressant + placebo

Intervention Type DRUG

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

Cariprazine 0.1 - 0.3 mg

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose

Group Type EXPERIMENTAL

Antidepressant + cariprazine (0.1-0.3 mg/day)

Intervention Type 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.

Cariprazine 1.0 - 2.0 mg

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose

Group Type EXPERIMENTAL

Antidepressant + cariprazine (1-2 mg/d)

Intervention Type 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.

Interventions

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Antidepressant + placebo

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

Intervention Type DRUG

Antidepressant + cariprazine (0.1-0.3 mg/day)

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.

Intervention Type DRUG

Antidepressant + cariprazine (1-2 mg/d)

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gedeon Richter Ltd.

INDUSTRY

Sponsor Role collaborator

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Hayes, PhD

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site 040

Phoenix, Arizona, United States

Site Status

Forest Investigative Site 038

Scottsdale, Arizona, United States

Site Status

Forest Investigative Site

Arcadia, California, United States

Site Status

Forest Investigative Site

Encino, California, United States

Site Status

Forest Investigative Site

Garden Grove, California, United States

Site Status

Forest Investigative Site

Irvine, California, United States

Site Status

Forest Investigative Site 013

Los Alamitos, California, United States

Site Status

Forest Investigative Site 041

National City, California, United States

Site Status

Forest Investigative Site

Oceanside, California, United States

Site Status

Forest Investigative Site 025

Denver, Colorado, United States

Site Status

Forest Investigative Site

Norwich, Connecticut, United States

Site Status

Forest Investigative Site

Washington D.C., District of Columbia, United States

Site Status

Forest Investigative Site 007

Jacksonville, Florida, United States

Site Status

Forest Investigative Site 012

West Palm Beach, Florida, United States

Site Status

Forest Investigative Site 033

Atlanta, Georgia, United States

Site Status

Forest Investigative Site

Roswell, Georgia, United States

Site Status

Forest Investigative Site

Overland Park, Kansas, United States

Site Status

Forest Investigative Site 042

Fall River, Massachusetts, United States

Site Status

Forest Investigative Site 034

Pittsfield, Massachusetts, United States

Site Status

Forest Investigative Site

Omaha, Nebraska, United States

Site Status

Forest Investigative Site

Cherry Hill, New Jersey, United States

Site Status

Forest Investigative Site 043

Brooklyn, New York, United States

Site Status

Forest Investigative Site 020

Mount Kisco, New York, United States

Site Status

Forest Investigative Site 039

New York, New York, United States

Site Status

Forest Investigative Site 029

New York, New York, United States

Site Status

Forest Investigative Site 001

The Bronx, New York, United States

Site Status

Forest Investigative Site 032

Raleigh, North Carolina, United States

Site Status

Forest Investigative Site

Canton, Ohio, United States

Site Status

Forest Investigative Site

Dayton, Ohio, United States

Site Status

Forest Investigative Site 015

Portland, Oregon, United States

Site Status

Forest Investigative Site 006

Media, Pennsylvania, United States

Site Status

Forest Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Forest Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Forest Investigative Site 023

Memphis, Tennessee, United States

Site Status

Forest Investigative Site 031

Memphis, Tennessee, United States

Site Status

Forest Investigative Site

Nashville, Tennessee, United States

Site Status

Forest Investigative Site

San Antonio, Texas, United States

Site Status

Forest Investigative Site

Woodstock, Vermont, United States

Site Status

Forest Investigative Site

Richmond, Virginia, United States

Site Status

Forest Investigative Site

Bellevue, Washington, United States

Site Status

Forest Investigative Site

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Fava M, Durgam S, Earley W, Lu K, Hayes R, Laszlovszky I, Nemeth G. Efficacy of adjunctive low-dose cariprazine in major depressive disorder: a randomized, double-blind, placebo-controlled trial. Int Clin Psychopharmacol. 2018 Nov;33(6):312-321. doi: 10.1097/YIC.0000000000000235.

Reference Type DERIVED
PMID: 30045066 (View on PubMed)

Other Identifiers

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RGH-MD-71

Identifier Type: -

Identifier Source: org_study_id

NCT03605784

Identifier Type: -

Identifier Source: nct_alias

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