Clinical Trial 45970

Garden Grove, CA 92845


Summary:

This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder.



Criteria:
  • Patients with a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)
  • Part B only: Stable treatment with a dopamine/serotonin (D2/5HT2A) antagonist or pure D2 antagonists, or a D2 partial agonist for a minimum of 6 months and receiving no more than two antipsychotics
  • Medically stable during the 3 months prior to study entry
  • Participant is an outpatient with no psychiatric hospitalizations within the prior 6 months
  • PANSS negative symptom factor score of 18 or higher
  • The following rating on items of the PANSS: (a) less than 5 on G8 (uncooperativeness), P1 (delusions), P3 (hallucinations), P4 (excitement/hyperactivity), and P6 (suspiciousness/persecution); (b) less than 4 on P7 (hostility), and G14 (poor impulse control)
  • Has an informant who is considered reliable by the Investigator
  • Body mass index (BMI) between 18-35 kg/m2 inclusive
  • Female participants are eligible to participate if not pregnant, not breastfeeding and agree to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 28 days after the last dose of study drug


Qualified Participants May Receive:

Monetary compensation for participating.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.