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To Evaluate the Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT01838876
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Cariprazine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 442 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Long-Term, Open-Label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
Actual Study Start Date : April 29, 2013
Actual Primary Completion Date : July 27, 2015
Actual Study Completion Date : July 27, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cariprazine
Cariprazine, flexible dose, oral administration, once daily for 26 weeks
Drug: Cariprazine
Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/d; patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration.




Primary Outcome Measures :
  1. Safety and Tolerability in patients with Major Depressive Disorder (assessments w ill include adverse events, clinical laboratory parameters, vital signs, Electrocardiograms, Extra Pyramidal Symptom (EPS) scales, and ophthalmologic examination) [ Time Frame: 26 Weeks ]


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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:

  • Patients who have provided consent prior to any study specific procedures
  • Meet the DSM-IV-TR criteria for MDD
  • New patients must have ongoing inadequate response to protocol allowed ADTs as reported in Antidepressant Treatment Response Questionnaire (ATRQ)
  • For rollover patients from RGH-MD-72, completion of Study RGH-MD-72 (either double-blind or single-blind treatment periods) with continued ADT treatment.

Exclusion Criteria:

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

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): NCT01838876


  Show 90 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Willie Earley, MD Allergan

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01838876     History of Changes
Other Study ID Numbers: RGH-MD-76
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Keywords provided by Forest Laboratories:
Major Depressive Disorder
MDD
Depression

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms