Lumateperone as Monotherapy for Bipolar Depression
Sponsor: |
Intra-cellular Therapeutics |
Enrolling: |
Male and Female Patients |
Study Length: |
8 Weeks |
Clinic Visits: |
9 |
IRB Number: |
7678 |
U.S. Govt. ID: |
NCT03249376 |
Contact: |
Peter Arden: 646-774-8004 / ardenpe@nyspi.columbia.edu |
This study is a double-blind and placebo-controlled study to assess its efficacy of the new drug Lumateperone for patients with Major Depressive Episodes associated with Bipolar I and Bipolar II disorder. Lumateperone is thought to exert its antidepressant effect through interaction with sereotogenic, dopaminergic, and glutamergic neurotransmitter targets.This is a 6 week outpatient study where patients will be given Lumateperone pills to take daily. A single dose will be taken each evening, starting with the evening of their baseline period. Following the discontinuation of medication, patients will be followed for two weeks. To date Lumateperone has been well tolerated with minimal side effects. Patients will receive $84 per visit they attend for a total of up to $756.
This study is closed
Investigator
David Hellerstein, MD
Are you currently taking antidepressant medication? |
Yes |
No |
Are you currently pregnant or breast feeding? |
Yes |
No |
Are you currently enrolled in Cognitive Behavioral Therapy (CBT) or planning on starting within the next 10 weeks? |
Yes |
No |
Do you think you may currently be experiencing a depressive episode? |
Yes |
No |