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Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 in Patients with Schizophrenia or Schizoaffective Disorder And Negative Symptoms; Protocol BP40283

RO6889450 is a novel compound and a potent partial agonist of Trace Amine-Associated Receptor 1 (TAAR1) for the treatment of negative symptoms in schizophrenia. This site is conducting Part B (add-on therapy) wherein participants will be randomized 1:1:1 to 45 mg QD of RO6889450, 150 mg QD of RO6889450, or placebo for 12 weeks. Stratification will be based on BNSS avolition/apathy subscore (sum of items “behavior” and “internal experience”; ≤6 vs. >6), age (18-35 years vs. 36-55 years), sex, and antipsychotic treatment (1:1 stratification ratio between dopamine 2 receptor [D2]/serotonin 2A [5HT2A] receptor antagonists and D2 partial agonist).

Study Length: 
Twenty weeks. Study participants will need to come at least 11 times to the study site during the study period.
Disorder/Condition: 
Schizophrenia
Inclusion Criteria: 
  • Stable outpatients with DSM-5 diagnosis of schizophrenia or schizoaffective disorder
  • 18 to 55 years of age
  • Stable treatment with a D2/5HT2A antagonists or a D2 partial agonist for a minimum of six months and receiving no more than two antipsychotics
  • Has an informant who is considered reliable to provide support and to help ensure compliance with study visits and protocol procedures
  • Body mass index (BMI) between 18 and 40 kg/m2 inclusive

Please note that this is not the full list of study eligibility criteria.

Study Title (brief): 
Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 in Patients with Schizophrenia or Schizoaffective Disorder And Negative Symptoms
Study Description (brief): 

RO6889450 is a novel compound and a potent partial agonist of Trace Amine-Associated Receptor 1 (TAAR1) for the treatment of negative symptoms in schizophrenia. This site is conducting Part B (add-on therapy) wherein participants will be randomized 1:1:1 to 45 mg QD of RO6889450, 150 mg QD of RO6889450, or placebo for 12 weeks. Stratification will be based on BNSS avolition/apathy subscore (sum of items “behavior” and “internal experience”; ≤6 vs. >6), age (18-35 years vs. 36-55 years), sex, and antipsychotic treatment (1:1 stratification ratio between dopamine 2 receptor [D2]/serotonin 2A [5HT2A] receptor antagonists and D2 partial agonist).

Study Contact: 

For more information about this study, please contact Dr. Malathi Perugula, research coordinator, at 212-961-8992 or malathi.perugula@nki.rfmh.org.

Exclusion Criteria: 
  • Moderate to severe substance use disorder within six months (excluding nicotine or caffeine) as defined by DSM-5
  • Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)
  • Significant medical and/or major neurologic disorder impairing cognition
  • Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenorphine, methadone, cannabinoids (including cannabidiol), cocaine and barbiturates
Study Location: 
Manhattan Psychiatric Center’s 125th Street Clinic -- 163 West 125th Street, 11th and 12th Floors, NY, NY 10027