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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669640
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

Condition or disease Intervention/treatment Phase
Schizophrenia, Schizoaffective Disorder Drug: RO6889450 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 in Patients With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : June 24, 2022
Estimated Study Completion Date : June 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Part A: Monotherapy
Participants will receive RO6889450 or a dose-matched placebo.
Drug: RO6889450
Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks.

Drug: Placebo
Participants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks.

Experimental: Part B: Add-On Therapy
Participants will receive a low or high dose of RO6889450 or a dose-matched placebo in addition to their usual anti-psychotic treatment(s).
Drug: RO6889450
Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks.

Drug: Placebo
Participants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks.




Primary Outcome Measures :
  1. Change from Baseline at Week 12 in Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline in Clinical Global Impression Severity (CGI-S) Overall Scores [ Time Frame: Baseline to week 12 ]
  2. Change from Baseline in CGI-S Negative Symptoms Scores [ Time Frame: Baseline to week 12 ]
  3. Clinical Global Impression Change (CGI-I) Overall Scores [ Time Frame: Week 12 ]
  4. CGI-I Negative Symptoms Scores [ Time Frame: Week 12 ]
  5. Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores [ Time Frame: Baseline to week 12 ]
  6. Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Symptom Factor Scores [ Time Frame: Baseline to week 12 ]
  7. Change from Baseline in Brief Negative Symptom Scale (BNSS) Total Scores [ Time Frame: Baseline to week 12 ]
  8. Change from Baseline in Brief Negative Symptom Scale (BNSS) Symptom Factor Scores [ Time Frame: Baseline to week 12 ]
  9. Change from Baseline in Defeatist Performance Attitude Scale (DPAS) Scores [ Time Frame: Baseline to week 12 ]
  10. Percentage of Participants with Adverse Events (AE) [ Time Frame: Baseline through the end of the follow-up period (approximately 16 weeks) ]
  11. Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Scores [ Time Frame: Baseline through the end of the follow-up period (approximately 16 weeks) ]
  12. Change from Baseline in Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A) [ Time Frame: Baseline through the end of the follow-up period (approximately 16 weeks) ]
  13. Area Under the Curve at Steady State (AUCss) of RO6889450 [ Time Frame: At pre-defined intervals from Day 7 through the end of the follow-up period (approximately 16 weeks) ]
  14. Maximum Serum Concentration (Cmax) of RO6889450 [ Time Frame: At pre-defined intervals from Day 7 through the end of the follow-up period (approximately 16 weeks) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 6 months prior to study entry
  • Outpatient with no hospitalization for worsening of schizophrenia or schizoaffective disorder within 6 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
  • Any 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669640


Contacts
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Contact: Reference Study ID Number: BP40283 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03669640    
Other Study ID Numbers: BP40283
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders