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

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ClinicalTrials.gov Identifier: NCT00854100
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Antidepressant + placebo Drug: Antidepressant + cariprazine (0.1-0.3 mg/day) Drug: Antidepressant + cariprazine (1-2 mg/d) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder
Actual Study Start Date : June 30, 2009
Actual Primary Completion Date : December 6, 2010
Actual Study Completion Date : December 6, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo
Drug: 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.

Experimental: Cariprazine 0.1 - 0.3 mg
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose
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.

Experimental: Cariprazine 1.0 - 2.0 mg
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose
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.




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline (Week 8) to Week 16 ]
    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.


Secondary Outcome Measures :
  1. Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Week 16 ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854100


  Show 41 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
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Study Director: Robert Hayes, PhD Forest Laboratories

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00854100     History of Changes
Obsolete Identifiers: NCT03605784
Other Study ID Numbers: RGH-MD-71
First Posted: March 2, 2009    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: February 2019
Keywords provided by Forest Laboratories:
Adjunctive
Depression
Major Depressive Disorder (MDD)
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Dexetimide
Cariprazine
Antidepressive Agents
Citalopram
Sertraline
Venlafaxine Hydrochloride
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists