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

NCT02600507 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 529

Last updated 2023-05-17

Study results available
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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.

Conditions

Interventions

DRUG

Lumateperone (ITI-007)

DRUG

Placebo

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Principal Investigators

  • Susan Kozauer, MD · Intra-Cellular Therapies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-07
Primary Completion
2020-07-02
Completion
2020-07-02
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Russia
  • Serbia
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02600507 on ClinicalTrials.gov