Trial Search Results

A Study to Assess the Effects of RO6889450 in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Stanford Investigator(s):

Intervention(s):

  • Drug: RO6889450
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion 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)

   - Medically stable during the six months prior to study entry

   - Outpatient with no hospitalization for worsening of schizophrenia or schizoaffective
   disorder within six months prior to study entry

   - 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

   - Part B only: Stable treatment with a dopamine/serotonin (D2/5HT2A) antagonist or a D2
   partial agonist for a minimum of 6 months and receiving no more than two
   antipsychotics

Exclusion Criteria:

   - Part A only: Confirmed suicidal behavior based on Investigator judgment or violent
   behavior resulting in injury or property damage in the prior five years

   - Part A only: Lifetime history of homicidal behavior

   - Moderate to severe substance use disorder within six months of study entry (excluding
   nicotine or caffeine) as defined by DSM-5

   - Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)

   - PANSS item G6 (depression) greater than or equal to 5

   - Significant risk of suicide or harming him- or herself or others according to the
   Investigator's judgment

   - A prior or current general medical condition that might be impairing cognition or
   other psychiatric functioning

   - Tardive dyskinesia that is moderate to severe or requires treatment

   - History of neuroleptic malignant syndrome

   - On more than one antidepressant, or if on one antidepressant, a change in dose within
   28 days prior to screening

   - History of clozapine treatment

   - Receipt of an investigational drug within 28 days or five times the half-life of the
   investigational drug (whichever is longer) before the first study drug administration

Ages Eligible for Study

18 Years - 55 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting