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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Depression

In brief

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.

Key facts

Study ID

NCT02600507

Run by

Intra-Cellular Therapies, Inc.

People needed

529

Starts

2016-03-07

Expected to finish

2020-07-02

Last updated by the study team

2023-05-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Site — Cerritos, California, United States
• Clinical Site — Costa Mesa, California, United States
• Clinical Site — Culver City, California, United States
• Clinical Site — Garden Grove, California, United States
• Clinical Site — Glendale, California, United States
• Clinical Site — Lemon Grove, California, United States
• Clinical Site — Oceanside, California, United States
• Clinical Site — Pico Rivera, California, United States
• Clinical Site — Riverside, California, United States
• Clinical Site — San Diego, California, United States
• Clinical Site — Santa Rosa, California, United States
• Clinical Site — Sherman Oaks, California, United States
• Clinical Site — Temecula, California, United States
• Clinical Site — Jacksonville, Florida, United States
• Clinical Site — Lauderhill, Florida, United States
• Clinical Site — Miami, Florida, United States
• Clinical Site — Orange City, Florida, United States
• Clinical Site — Orlando, Florida, United States
• Clinical Site — Atlanta, Georgia, United States
• Clinical Site — Savannah, Georgia, United States
• Clinical Site — Chicago, Illinois, United States
• Clinical Site — Lake Charles, Louisiana, United States
• Clinical Site — Baltimore, Maryland, United States
• Clinical Site — O'Fallon, Missouri, United States
• Clinical Site — Rogers, Arkansas, United States

Full record on ClinicalTrials.gov

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