Phase 2 N=213 Randomized Double-blind Treatment

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

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT02953639 ↗

Enrolled (actual)

213

Serious AEs

4.2%

Results posted

Feb 2021

Primary outcome: Primary: Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score — 32.50; 32.36; -0.17; -0.28 Composite T-Score — p=0.730

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Basmisanil (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score	32.50; 32.36; -0.17; -0.28; 1.08; 1.36	0.730
SECONDARY Change From Baseline to Week 24 in MCCB Cognitive Domain Scores	40.75; 39.66; -0.16; -0.14; 0.63; 0.51	0.556
SECONDARY Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score	31.14; 32.30; 2.14; 0.36; 4.42; 5.09	0.211
SECONDARY Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score	16.55; 16.22; -2.60; -0.83; -3.02; -2.29	0.164
SECONDARY Change From Baseline to Week 24 in Ratio Between Trail Making Test (TMT)- Part B and TMT- Part A Scores	3.27; 3.12; -0.37; -0.12; -0.23; -0.06	0.527
SECONDARY Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score	59.82; 60.88; 3.13; 2.26; 3.75; 4.14	0.323
SECONDARY Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score	37.07; 36.53; -2.91; -3.66; -3.71; -4.02	0.493
SECONDARY Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating	2.45; 2.39; -0.21; -0.24; -0.19; -0.29	0.839
SECONDARY Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating	-0.45; -0.45; -0.62; -0.64	0.865
SECONDARY Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS)	33.81; 34.21; -2.26; 0.21; -0.78; -4.32	0.142
SECONDARY Percentage of Participants With Adverse Events (AEs)	39.5; 46.3; 48.7	—
SECONDARY Apparent Clearance of Basmisanil at Steady State (CL/F,ss)	—	—
SECONDARY Apparent Volume of Distribution of Basmisanil at Steady State (Vz/F,ss)	—	—
SECONDARY Area Under the Curve of Basmisanil at Steady State (AUC,ss)	41640; 87624	—
SECONDARY Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss)	2079; 4374	—

Summary

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

Eligibility 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 </=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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02953639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.