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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 February 2013 |
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Main ID: |
NCT01360632 |
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Date of registration:
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24/05/2011 |
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Primary sponsor: |
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Public title:
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Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
Polaris |
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Scientific title:
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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Two Fixed Doses of OPDC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Polaris Trial |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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1650 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01360632 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Germany
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Hungary
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Romania
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Russian Federation
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Ukraine
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United States
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Contacts
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Name:
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INC Research |
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Address:
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Telephone:
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Email:
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sm_opdc.ctgov@incresearch.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female subjects between 18 and 65 years of age, with diagnosis of major
depressive disorder, as defined by DSM-IV-TR criteria
- The current depressive episode must be equal to or greater than 8 weeks in duration
- Subjects must report a history for the current depressive episode of an inadequate
response to no more than three adequate antidepressant treatments
Exclusion Criteria:
- Females who are breast-feeding and/or who have a positive pregnancy test result prior
to receiving study drug
- Subjects who report an inadequate response to more than three adequate trials of
antidepressant treatments during current depressive episode at a therapeutic dose for
an adequate duration
- Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia, amnestic
or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other
psychotic disorder, Bipolar I or II disorder
- Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of
borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality
disorder
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Depression
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Depressive Disorder
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Depressive Disorder, Major
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Mental Disorders
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Mood Disorders
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Intervention(s)
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Drug: OPC-34712 + ADT
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Drug: Placebo + ADT
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Primary Outcome(s)
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Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from randomization to the end of treatment
[Time Frame: Week 14]
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Secondary Outcome(s)
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Change in Sheehan Disability Scale (SDS) from randomization to end of treatment
[Time Frame: Week 14]
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Secondary ID(s)
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331-10-227
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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