Obsessive Compulsive Disorder - Torrance CA (Metro Los Angeles)

Summary:

The purpose of this study is to compare the efficacy of BHV-4157 versus placebo in subjects with Obsessive Compulsive Disorder (OCD).

• Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders.

• Subjects must be currently experiencing non-response or inadequate response to their current Standard of Care (SOC) medication defined as:

  1. Subjects Y-BOCS total score must be ≥ 19 at Screening and Baseline, reflecting moderate or severe OCD symptoms.
  2. Subjects must currently be on a selective serotonin reuptake inhibitor (SSRI), clomipramine, venlafaxine or desvenlafaxine.
• Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed;
• Minimum of 6 years of education or equivalent and sufficiently fluent in English to complete necessary scales and understand consent forms;
• Subjects must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol;
• Subjects must be able to understand and agree to comply with the prescribed dosage regimens and procedures; report for regularly scheduled office visits; and reliably communicate with study personnel about adverse events and concomitant medications;
• It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study (i.e. beginning 30 days prior to baseline and extending to 30 days after the last dose of study drug).
• Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline;
• It is required that men who are sexually active with WOCBP agree to use two methods of contraception for the duration of the study (beginning at first treatment and extending to 90 days after the last dose of study drug).

Qualified Participants May Receive:

Monetary compensation for participating.