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 [2].

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