LUMATEPERONE AS ADJUNCTIVE THERAPY FOR BIPOLAR DEPRESSION
Sponsor: |
Intra-cellular Therapies |
Enrolling: |
Male and Female Patients |
Study Length: |
10 Weeks |
Clinic Visits: |
10 |
IRB Number: |
7679 |
U.S. Govt. ID: |
NCT02600507 |
Contact: |
Peter Arden: 646-774-8000 / Peter.Arden@nyspi.columbia.edu |
This study is a double-blind and placebo-controlled study to assess its efficacy of the new drug Lumateperone for patients already taking lithium or Depakote but are still suffering from symptoms of depression as a product of bipolar disorder. Lumateperone is thought to exert its antidepressant effect through interaction with sereotogenic, dopaminergic, and glutamergic neurotransmitter targets.This is a 10 week outpatient study where patients will be given Lumateperone pills to take daily in combination with their current mood stabilizers. 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 a total of up to $756 for completing all visits.
This study is closed
Investigator
David Hellerstein, MD
Are you currently taking lithium or Depakote (valporate)? |
Yes |
No |
Are you currently taking any other antidepressant medications such as SSRIs, SNRIs, etc.? |
Yes |
No |
Are you pregnant or planning on becoming pregnant in the the next 3 months? |
Yes |
No |
Do you have any history of seizures or epilepsy? |
Yes |
No |