Bipolar Disorder
Bipolar disorder is a mental health condition that causes extreme mood swings, including emotional highs (mania) and lows (depression), affecting daily life and relationships.
Bipolar Mania: Lumateperone Study
We are evaluating the safety and effectiveness of lumateperone for treating manic episodes in patients with bipolar I disorder. This study compares the medication to a placebo to see how well it works.
What diseases are being studied?
Health conditions and diseases that the clinical trial is designed to study and treat.
Who can participate in the clinical trial?
These questions help us understand your situation so we can let the trial team know whether you might be a potential match. This is not a medical evaluation and is not part of the official screening, the study doctor will make the final decision..
- Are you between 18 and 75 years old?
- Do you have bipolar disorder with a current episode of mania?
- Have you been hospitalized for mania in the last 14 days?
- Have you had any suicidal thoughts or attempts in the last 2 years?
- Have you received electroconvulsive therapy (ECT) in the past year?
What experimental substances are being tested?
Experimental substances that are being investigated in this clinical trial. These are not yet approved for general use.
Lumateperone
Where is the clinical trial being conducted?
Locations and medical facilities where this clinical trial is currently recruiting or conducting research. Select the locations where you would like to participate.
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Center For Mental Health Prof. Dr. Ivan Temkov Burgas EOOD
Department for Treatment of Emergency Psychiatric Conditions
Burgas, Bulgaria
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD
Department of psychiatry
Kazanlak, Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Psychiatry
Plovdiv, Bulgaria
Sponsor: Intra-Cellular Therapies Inc.
Last updated: Nov 26, 2025
Disclaimer: Parts of this content have been automatically extracted from the EU Clinical Trials registry. While we strive for accuracy, please always contact the trial site or sponsor directly for correct and official information before making any decisions about participation. View on EU Clinical Trials.