Does your child suffer from depression due to bipolar disorder?

Join a study for teenagers with bipolar depression

a study on Depression Bipolar Disorder

Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at Sherman Oaks, California and other locations
Dates
study started
study ends

Description

Summary

This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.

Official Title

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Details

At the Screening/Baseline Visit (Visit 1/Day 1), which is the same visit as Visit 8/Day 43 of the lead-in study, eligible patients will receive open-label lumateperone 42 mg once daily for approximately 26 weeks. Patients will continue their background ADT from the lead-in study. Patients will be seen for weekly visits through Visit 5/Week 4. Thereafter, visits will occur every two weeks. A Safety Follow-up visit will occur on Visit 17/Day 197, approximately 2 weeks after the last dose of open-label lumateperone 42 mg.

Keywords

Major Depressive Disorder, Adjunctive MDD Therapy, lumateperone, Lumateperone 42 mg

Eligibility

You can join if…

Open to people ages 18-65

  1. In the opinion of the Investigator, patients must have safely completed the lead-in study.
  2. Patient is taking their ADT as prescribed from the lead-in study.

You CAN'T join if...

  1. In the opinion of the Investigator, the patient is unable to comply with study procedures or judged to be inappropriate for the study.
  2. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or:
    1. At the Screening/Baseline Visit, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C SSRS "Since Last Visit" version;
    2. At the Screening/Baseline visit, the patient scores ≥ 5 on the MADRS Item 10 (Suicidal Thoughts).
  3. Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or ECG results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study.

Locations

  • Clinical Site
    Sherman Oaks California 91403 United States
  • Clinical Site
    Glendale California 91206 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
Intra-Cellular Therapies, Inc.
Links
Sign up for this study
ID
NCT05061719
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 812 people participating
Last Updated
Contact us about this trial