Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

NCT01715805 | Completed Phase 3 Results

• 1 other identifier: RGH-MD-72
• Study Type: interventional
• Target: 1,022
• Locations: 2 countries
• Sites: 85

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

MDD; Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period

  The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.

  Baseline (Week 8)

• Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period

  The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.

  Baseline (Week 8) to Week 16

Secondary Outcomes (1)

• Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period

  Baseline (Week 8) to Week 16

Study Arms (4)

Placebo + ADT Lead-in

OTHER

Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.

Drug: Placebo; Drug: Antidepressant Therapy (ADT)

Placebo + ADT (Double-Blind)

PLACEBO COMPARATOR

Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).

Drug: Placebo; Drug: Antidepressant Therapy (ADT)

Cariprazine + ADT (Double-Blind)

EXPERIMENTAL

Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).

Drug: Cariprazine; Drug: Antidepressant Therapy (ADT)

Placebo + ADT (Continued Treatment)

OTHER

Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.

Drug: Placebo; Drug: Antidepressant Therapy (ADT)

Interventions

Cariprazine DRUG

Cariprazine capsules 1.5 to 4.5 mg/day

Cariprazine + ADT (Double-Blind)

Placebo DRUG

Dose-matched placebo capsule once per day

Placebo + ADT (Continued Treatment); Placebo + ADT (Double-Blind); Placebo + ADT Lead-in

Antidepressant Therapy (ADT) DRUG

ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.

Cariprazine + ADT (Double-Blind); Placebo + ADT (Continued Treatment); Placebo + ADT (Double-Blind); Placebo + ADT Lead-in

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have provided consent prior to any specific procedure
• Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
• Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2

You may not qualify if:

• Patients who do not meet DSM-IV-TR criteria for MDD

Sponsors & Collaborators

• Forest Laboratories: lead
• Gedeon Richter Ltd.: collaborator

Study Sites (85)

Forest Investigative Site 032

Tucson, Arizona, 85710, United States

Location

Forest Investigative Site 018

Little Rock, Arkansas, 72211, United States

Location

Forest Investigative Site 029

Little Rock, Arkansas, 72211, United States

Location

Forest Investigative Site 084

Cerritos, California, 90703, United States

Location

Forest Investigative Site 085

Culver City, California, 90230, United States

Location

Forest Investigative Site 082

Garden Grove, California, 92845, United States

Location

Forest Investigative Site 022

Newport Beach, California, 92660, United States

Location

Forest Investigative Site 004

Oceanside, California, 92056, United States

Location

Forest Investigative Site 090

Rancho Mirage, California, 92270, United States

Location

Forest Investigative Site 078

Redlands, California, 92374, United States

Location

Forest Investigative Site 080

Redlands, California, 92374, United States

Location

Forest Investigative Site 007

San Diego, California, 92103, United States

Location

Forest Investigative Site 054

San Diego, California, 92108, United States

Location

Forest Investigative Site 031

Temecula, California, 92591, United States

Location

Forest Investigative Site 048

Denver, Colorado, 80239, United States

Location

Forest Investigative Site 037

Coral Springs, Florida, 33067, United States

Location

Forest Investigative Site 053

Fort Myers, Florida, 33912, United States

Location

Forest Investigative Site 023

Hallandale, Florida, 33009, United States

Location

Forest Investigative Site 071

Hialeah, Florida, 33012, United States

Location

Forest Investigative Site 006

Leesburg, Florida, 34748, United States

Location

Forest Investigative Site 026

Miami, Florida, 33145, United States

Location

Forest Investigative Site 075

Miami, Florida, 33165, United States

Location

Forest Investigative Site 027

North Miami, Florida, 33161, United States

Location

Forest Investigative Site 074

North Miami, Florida, 33161, United States

Location

Forest Investigative Site 036

Oakland Park, Florida, 33334, United States

Location

Forest Investigative Site 051

Orlando, Florida, 32803, United States

Location

Forest Investigative Site 044

South Miami, Florida, 33143, United States

Location

Forest Investigative Site 008

Tampa, Florida, 33613, United States

Location

Forest Investigative Site 019

Winter Park, Florida, 32789, United States

Location

Forest Investigative Site 060

Atlanta, Georgia, 30306, United States

Location

Forest Investigative Site 024

Atlanta, Georgia, 30331, United States

Location

Forest Investigative Site 017

Marietta, Georgia, 30060, United States

Location

Forest Investigative Site 047

Smyrna, Georgia, 30080-6315, United States

Location

Forest Investigative Site 070

Chicago, Illinois, 60612, United States

Location

Forest Investigative Site 013

Hoffman Estates, Illinois, 60169, United States

Location

Forest Investigative Site 063

Libertyville, Illinois, 60048, United States

Location

Forest Investigative Site 062

Maywood, Illinois, 60153, United States

Location

Forest Investigative Site 072

Naperville, Illinois, 60563, United States

Location

Forest Investigative Site 010

Oak Brook, Illinois, 60523, United States

Location

Forest Investigative Site 068

Skokie, Illinois, 60076, United States

Location

Forest Investigative Site 061

Indianapolis, Indiana, 46260, United States

Location

Forest Investigative Site 042

Lafayette, Indiana, 47905, United States

Location

Forest Investigative Site 065

Overland Park, Kansas, 66211, United States

Location

Forest Investigative Site 073

New Orleans, Louisiana, 70115, United States

Location

Forest Investigative Site 049

Gaithersburg, Maryland, 20877, United States

Location

Forest Investigative Site 077

Rockville, Maryland, 20850, United States

Location

Forest Investigative Site 012

Rockville, Maryland, 20852, United States

Location

Forest Investigative Site 046

Boston, Massachusetts, 02131, United States

Location

Forest Investigative Site 045

Natick, Massachusetts, 01760, United States

Location

Forest Investigative Site 086

Saint Charles, Missouri, 63304, United States

Location

Forest Investigative Site 014

Toms River, New Jersey, 08755, United States

Location

Forest Investigative Site 058

Albuquerque, New Mexico, 87109, United States

Location

Forest Investigative Site 028

Brooklyn, New York, 11214, United States

Location

Forest Investigative Site 016

New York, New York, 10023, United States

Location

Forest Investigative Site 083

New York, New York, 10028, United States

Location

Forest Investigative Site 025

Staten Island, New York, 10305, United States

Location

Forest Investigative Site 076

The Bronx, New York, 10467, United States

Location

Forest Investigative Site 050

Durham, North Carolina, 27710, United States

Location

Forest Investigative Site 067

Bismarck, North Dakota, 58501, United States

Location

Forest Investigative Site 088

Canton, Ohio, 44718, United States

Location

Forest Investigative Site 089

Cincinnati, Ohio, 45215, United States

Location

Forest Investigative Site 011

Cincinnati, Ohio, 45219, United States

Location

Forest Investigative Site 015

Cincinnati, Ohio, 45227, United States

Location

Forest Investigative Site 055

Columbus, Ohio, 43210, United States

Location

Forest Investigative Site 066

Mason, Ohio, 45040, United States

Location

Forest Investigative Site 064

Middleburg Heights, Ohio, 44130, United States

Location

Forest Investigative Site 035

Oklahoma City, Oklahoma, 73103, United States

Location

Forest Investigative Site 038

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 039

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 003

Portland, Oregon, 97210, United States

Location

Forest Investigative Site 052

Allentown, Pennsylvania, 18104, United States

Location

Forest Investigative Site 059

Lincoln, Rhode Island, 02865, United States

Location

Forest Investigative Site 001

Charleston, South Carolina, 29425, United States

Location

Forest Investigative Site 079

Austin, Texas, 78732, United States

Location

Forest Investigative Site 005

Houston, Texas, 77008, United States

Location

Forest Investigative Site 087

The Woodlands, Texas, 77381, United States

Location

Forest Investigative Site 069

Wichita Falls, Texas, 76309, United States

Location

Forest Investigative Site 030

Orem, Utah, 84058, United States

Location

Forest Investigative Site 041

Charlottesville, Virginia, 22903, United States

Location

Forest Investigative Site 081

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 043

Seattle, Washington, 98104, United States

Location

Forest Investigative Site 056

Milwaukee, Wisconsin, 53227, United States

Location

Forest Investigative Site 057

Waukesha, Wisconsin, 53188, United States

Location

Forest Investigative Site 033

San Juan, 00918, Puerto Rico

Location

Forest Investigative Site 034

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Willie Earley, MD

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: November 15, 2012
• Primary Completion: June 24, 2016
• Study Completion: June 24, 2016
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Locations

US (83); PR (2)