CompletedPhase 3

Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

United States529 participantsStarted 2016-03-07

Plain-language summary

The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder * experiencing a current major depressive episode * treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms Exclusion Criteria: * any subject unable to provide informed consent * any female subject who is pregnant or breastfeeding * any subject judged to be medically inappropriate for study participation

What they're measuring

Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

Timeframe: Baseline to Day 43

Trial details

NCT IDNCT02600507

SponsorIntra-Cellular Therapies, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-02

Results submitted2023-04-24

View on ClinicalTrials.gov More Bipolar Depression trials