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A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics

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ClinicalTrials.gov Identifier: NCT02953639
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multicenter study will assess the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Basmisanil Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIb, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Basmisanil (RO5186582) as Adjunctive Treatment in Patients With Cognitive Impairment Associated With Schizophrenia Treated With Antipsychotics
Actual Study Start Date : November 30, 2016
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Basmisanil 240 mg
Participants will receive basmisanil twice daily orally for 24 weeks.
Drug: Basmisanil
Participants will receive either 80 milligrams (mg) or 240 mg of basmisanil twice daily orally for 24 weeks.

Experimental: Basmisanil 80 mg
Participants will receive basmisanil twice daily orally for 24 weeks.
Drug: Basmisanil
Participants will receive either 80 milligrams (mg) or 240 mg of basmisanil twice daily orally for 24 weeks.

Placebo Comparator: Placebo
Participants will receive matching placebo to basmisanil twice daily orally for 24 weeks.
Drug: Placebo
Participants will receive placebo-matched to basmisanil orally twice daily for 24 weeks.




Primary Outcome Measures :
  1. Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocomposite Score [ Time Frame: Baseline, up to Week 24 ]

Secondary Outcome Measures :
  1. Change From Baseline to Week 24 in MCCB Cognitive Domain Scores [ Time Frame: Baseline, up to Week 24 ]
  2. Change From Baseline to Week 24 in Wechsler Memory Scale Fourth edition, Verbal Paired Associates (WMS IV-PAL) Score [ Time Frame: Baseline, up to Week 24 ]
  3. Change From Baseline to Week 24 in Wechsler Memory Scale Fourth edition, Logical Memory Test (WMS IV-LM) Score [ Time Frame: Baseline, up to Week 24 ]
  4. Change From Baseline to Week 24 in Ratio Between Trail Making Test (TMT)- Part B and TMT- Part A Scores [ Time Frame: Baseline, up to Week 24 ]
  5. Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score [ Time Frame: Baseline, up to Week 24 ]
  6. Change From Baseline to Week 24 Schizophrenia Cognition Rating Scale (SCoRS) [ Time Frame: Baseline, up to Week 24 ]
  7. Change From Baseline to Week 24 Clinical Global Impression Severity (CGI-S) Rating [ Time Frame: Baseline, up to Week 24 ]
  8. Clinical Global Impression Improvement (CGI-I) Rating [ Time Frame: Baseline, up to Week 24 ]
  9. Change From Baseline in Schizophrenia Quality of Life Scale (SQLS) [ Time Frame: Baseline, up to Week 24 ]
  10. Smartphone-Based Likert Scale Assessment [ Time Frame: Baseline, up to Week 24 ]
  11. Percentage of Participants With Adverse Events [ Time Frame: Baseline, up to Week 28 ]
  12. Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated Version (ESRS-A) [ Time Frame: Baseline, up to Week 24 ]
  13. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, up to Week 24 ]
  14. Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, up to Week 28 ]
  15. Change From Baseline in Nurses' Observation Scale (NOSIE-30) [ Time Frame: Baseline, up to Day 7 ]
  16. Apparent Clearance of Basmisanil [ Time Frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 ]
  17. Apparent Volume of Distribution of Basmisanil [ Time Frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 ]
  18. Area Under the Curve (AUC) of Basmisanil [ Time Frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 ]
  19. Maximum Plasma Concentration (Cmax) of Basmisanil [ Time Frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia of any type utilizing the Mini International Neuropsychiatric Interview and diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) direct clinical assessments, family informants and past medical records
  • Evidence of stability of symptoms for 3 months at screening, that is, without hospitalizations for schizophrenia or increase in level of psychiatric care due to worsening of symptoms of schizophrenia
  • Participants with schizophrenia clinical symptom severity defined by the following: hallucinatory behavior item score less than or equal to (</=) 5 and a delusion item score </= 5 of the PANSS
  • Participants on a stable regimen of antipsychotic therapy for at least 3 months at screening and receiving no more than two antipsychotics

Exclusion Criteria:

  • Participants with current DSM-5 diagnosis other than schizophrenia including bipolar disorder, schizoaffective disorder and major depressive disorder
  • Clinically significant neurological illness or significant head trauma that affects cognitive function, in the judgment of the principal investigator
  • Full scale intelligence quotient <70 on the Wechsler Abbreviated Scale of Intelligence at screening
  • Positive result at screening for hepatitis B, hepatitis C, or human immunodeficiency virus-1 and 2
  • Moderate to severe substance use disorder (other than nicotine or caffeine), as defined by the DSM-5, within the last 12 months
  • Suicide attempt within 1 year or currently at risk of suicide in the opinion of the Investigator

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): NCT02953639


Contacts
Contact: Reference Study ID Number: BP39207 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02953639     History of Changes
Other Study ID Numbers: BP39207
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs