Study Seeking Patients with Bipolar Depression

  • STATUS
    Recruiting
  • sponsor
    ITI
Updated on 25 March 2021

Summary

Study Seeking Patients with Bipolar Depression

Description

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF ITI-007 ADJUNCTIVE TO LITHIUM OR VALPROATE IN THE TREATMENT OF PATIENTS WITH MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I OR II DISORDER (BIPOLAR DEPRESSION)

Details
Clinical Study IdentifierTX148331
SponsorITI
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or Female 18 to 65 years inclusive
BMI of 19-35 kg/m2
Have DSM 5 Diagnosis of Bipolar I or II
In current Major Depressive episode of at least 2 weeks but no more than 6 months
Lifetime history of at least one manic or mixed episode

Exclusion Criteria

Current risk of suicide; suicide attempt within 2 years
History within 12 months of any other diagnosis other than bipolar disorder
Any psychotic symptoms in current episode (hallucinations/delusions)
Hospitalization for mania within 30 days of screening
Rapid Cycler
Positive UDS at screen (except THC or prescribed benzos)
Hepatitis B or C/HIV
Clear my responses

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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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