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Clinical Trials/NCT02953639
NCT02953639
Completed
Phase 2

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

Hoffmann-La Roche37 sites in 1 country214 target enrollmentStarted: November 30, 2016Last updated:
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ConditionsSchizophrenia
InterventionsPlaceboBasmisanil
DrugsBasmisanilPlacebo

Overview

Phase
Phase 2
Status
Completed
Enrollment
214
Locations
37
Primary Endpoint
Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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 \</=65 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

Arms & Interventions

Placebo

Placebo Comparator

Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.

Intervention: Placebo (Drug)

Basmisanil 80mg BID

Experimental

Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.

Intervention: Basmisanil (Drug)

Basmisanil 240mg BID

Experimental

Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.

Intervention: Basmisanil (Drug)

Outcomes

Primary Outcomes

Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score

Time Frame: Baseline up to Week 24

The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB neurocognitive composite T-score is a standardized mean of the six domain scores (excluding social cognition). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher composite T-score represents lower impairment.

Secondary Outcomes

  • Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score(Baseline up to Week 24)
  • Change From Baseline to Week 24 in Ratio Between Trail Making Test (TMT)- Part B and TMT- Part A Scores(Baseline up to Week 24)
  • Apparent Clearance of Basmisanil at Steady State (CL/F,ss)(Pre-dose (hour 0) in Days 7, 14, 42, 84, 168)
  • Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss)(Pre-dose (hour 0) in Days 7, 14, 42, 84, 168)
  • Change From Baseline to Week 24 in MCCB Cognitive Domain Scores(Baseline up to Week 24)
  • Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score(Baseline up to Week 24)
  • Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score(Baseline up to Week 24)
  • Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score(Baseline up to Week 24)
  • Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating(Baseline up to Week 24)
  • Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating(Baseline up to Week 24)
  • Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS)(Baseline up to Week 24)
  • Percentage of Participants With Adverse Events (AEs)(Baseline up to 4 weeks after the last dose of study drug (up to 28 weeks))
  • Apparent Volume of Distribution of Basmisanil at Steady State (Vz/F,ss)(Pre-dose (hour 0) in Days 7, 14, 42, 84, 168)
  • Area Under the Curve of Basmisanil at Steady State (AUC,ss)(Pre-dose (hour 0) in Days 7, 14, 42, 84, 168)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (37)

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