[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

877-277-8566

Email address

IR-CTRegistration@allergan.com

Condition

Bipolar I Disorder,Depression,Mania

Treatment type

Interventional

Investigational product

Cariprazine

Phase

Phase 3

Sponsor

Forest Laboratories

ClinicalTrials.gov identifier

NCT03573297

Study number

RGH-MD-25

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About the study

1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/d compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/d

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, current episode manic, with or without mixed features
  2. A total YMRS score ≥ 20 and a score of at least 4 on 2 of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior, or bipolar I disorder, current episode depressive, with or without mixed features
  3. Having a MADRS total score ≥ 23 and a score of at least 3 on 2 of the following MADRS items: apparent sadness, reported sadness, inner tension or inability to feel
Exclusion criteria
  1. Four or more episodes of a mood disturbance within the 12 months before Visit 1
  2. Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site