Summary

for people ages 18-65 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

A Randomized, Double-blind, Placebo-controlled Trial of Adjunctive BHV-4157 in Obsessive Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder Disease Compulsive Personality Disorder BHV-4157

Eligibility

You can join if…

Open to people ages 18-65

  1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of the subject's illness must be ≥ 1 year;
  2. Subjects must be currently experiencing non-response or inadequate response to their current Standard of Care (SOC) medication defined as:
  3. Subjects Y-BOCS total score must be ≥ 19 at Screening and Baseline, reflecting moderate or severe OCD symptoms.
  4. Subjects must currently be on a selective serotonin reuptake inhibitor (SSRI),clomipramine, venlafaxine or desvenlafaxine for an adequate duration and at an adequate dose defined as:
  5. Adequate Duration: At least 8 weeks at screening and 10 weeks of SSRI,clomipramine, venlafaxine or desvenlafaxine at Baseline.

ii. Adequate Dose: Defined by the USPI labeling.

  1. Subjects must be on stable doses of other psychotropic medication (with exclusions)for at least 12 weeks prior to screening;
  2. CGI-S score of ≥ 4 at screening and baseline;
  3. 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;
  4. Minimum of 6 years of education or equivalent and sufficiently fluent in English to complete necessary scales and understand consent forms;
  5. Subjects must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol;
  6. 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;
  7. 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). The two methods should include:
  8. one barrier method (e.g. diaphragm with spermicide, condom with spermicidal gel,intrauterine devices, cervical cap);
  9. and one other method. The other method could include oral contraceptives or another barrier method (Section 5.5);
  10. . Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline;
  11. . 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).

You CAN'T join if...

  1. Subjects should be excluded with a history of more than two (2) previous failed treatment trials of SSRIs, clomipramine, venlafaxine, or desvenlafaxine (not including the current SSRI trial) given for an adequate duration at an adequate dose as defined by the following criteria taken from the MGH-TRQ-OCD as:
  2. Treatment failure / non-response: As per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the patient despite an adequate dose and duration of treatment;
  3. Adequate duration: At least 10 weeks of treatment with SSRI, clomipramine,venlafaxine, or desvenlafaxine
  4. Adequate dose: Defined by the USPI labeling.
  5. Subjects should be excluded at screening or baseline if any medical or psychiatric condition other than OCD, as specified in the inclusion criteria, could predominantly explain or contribute significantly to the subjects' symptoms or that could confound assessment of OCD symptoms;
  6. MMSE score of < 24 at Screening;
  7. Current or prior history, per DSM-V criteria, of bipolar I or II disorder,schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorder as part of the OCD diagnosis are allowed, but a primary diagnosis of hoarding disorder is excluded); a current diagnosis of Tourette's disorder is also excluded;
  8. Any eating disorder within the last 12 months;
  9. Primary active major depressive episode or primary active anxiety disorder within the past 6 months. Note: Subjects on a stable maintenance dose of a non-tricyclic,non-monoamine oxidase inhibitor (MAOI) antidepressant medication with symptoms in remission may be eligible if the subject has been treated with a stable dose for at least 3 months prior to randomization and no dose changes are expected throughout the randomization phase of the study;
  10. Acute suicidality or suicide attempt or self-injurious behavior in the last 12 months;
  11. Score of >0 on the Sheehan Suicidality Tracking Scale for the period of 6 months prior to screening, and at baseline;
  12. Brown Assessment of Beliefs (BABS) score >17 at screening and baseline;
  13. . History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy(ECT).
  14. . Transcranial Magnetic Stimulation (TMS) is prohibited within three months prior to screening and during the study.

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92037 United States
  • Artemis Institute for Clinical Research accepting new patients
    San Diego California 92103 United States
  • Synergy Research San Diego accepting new patients
    National City California 91950 United States
  • Artemis Institute for Clinical Research accepting new patients
    San Marcos California 92078 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Biohaven Pharmaceuticals, Inc.
ID
NCT03299166
Phase
Phase 2/3
Study Type
Interventional
Last Updated
June 7, 2018