[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

646 440 9333

Email address

ITCIClinicalTrials@itci-inc.com

Condition

Bipolar Depression,Major Depressive Disorder

Treatment type

Interventional

Investigational product

Lumateperone

Phase

Phase 3

Sponsor

Intra-Cellular Therapies, Inc.

ClinicalTrials.gov identifier

NCT04285515

Study number

ITI-007-403

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About the study

This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.

Who can take part?

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

Inclusion criteria
  1. Male or female subjects of any race, ages 18-75 inclusive
  2. Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD
  3. The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1)
  4. Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥ 24 and corresponding to a CGI S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2)
  5. The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis
  6. Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning
  7. Able to provide written informed consent Major
Exclusion criteria
  1. Any female subject who is pregnant or breast-feeding
  2. Any subject judged to be medically inappropriate for study participation
  3. The patient has a significant risk for suicidal behavior
  4. The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma

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

Study locations

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How to apply

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