Study Seeking Patients with Bipolar Depression

  • STATUS
    Recruiting
  • sponsor
    Allergan
Updated on 8 November 2020

Summary

Study Seeking Patients with Bipolar Depression

Description

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, PARALLEL-GROUP, MULTICENTER, FIXED-DOSE CLINICAL TRIAL EVALUATING THE EFFICACY, SAFETY AND TOLERABILITY OF CARIPRAZINE IN PATIENTS WITH BIPOLAR I DEPRESSION

Details
Condition Bipolar Disorder, Depression
Clinical Study IdentifierTX148289
SponsorAllergan
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female outpatients who are 18 to 65 years of age, meet Diagnostic and
Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder without psychotic features confirmed by the administration of the Mini International Neuropsychiatric Interview (MINI), with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration, a minimum score of 20 on the 17-item Hamilton Depression Rating Scale (HAMD-17), a minimum score of 2 on item 1 of the HAMD-17, and a minimum score of 4 on the Clinical Global Impressions-Severity Scale (CGI-S) at Visit 1
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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