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Completed

NCT Number: NCT01469377

Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Forest Investigative Site 201, Tallinn, Estonia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female outpatients 18 to 65 years of age, inclusive.
  • Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
  • Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
  • Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

Exclusion criteria

  • Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
  • Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.
  • History of meeting DSM-IV-TR criteria for:
  • Depressive episode with psychotic or catatonic features.
  • Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
  • Schizophrenia, schizoaffective, or other psychotic disorder.
  • Obsessive-compulsive disorder.
  • Bulimia or anorexia nervosa.
  • Dementia, amnesic, or other cognitive disorder.
  • Mental retardation.
  • Participants considered a suicide risk.

Treatment and study plan

Placebo

Drug

Placebo was supplied in capsules

Cariprazine

Drug

Cariprazine was supplied in capsules.

Primary outcomes

  1. Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8

    Time frame: Baseline to Week 8

    The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Secondary outcomes

  1. Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8

    Time frame: Baseline to Week 8

    The SDS measures an individual's perception of the extent to which his or her emotional symptoms are disrupting his or her functioning in 3 domains, work/school, social life/leisure activities, and family life/home responsibilities. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Collaborators

  • Gedeon Richter Ltd.

Registry information

Official study title

A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy in Major Depressive Disorder

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 10, 2011
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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