Clinical trial NCT02953639: A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score
timeFrame: Baseline up to Week 24
Secondary outcomes:
measure: Change From Baseline to Week 24 in MCCB Cognitive Domain Scores
timeFrame: Baseline up to Week 24
measure: Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score
timeFrame: Baseline up to Week 24
measure: Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score
timeFrame: Baseline up to Week 24
measure: Change From Baseline to Week 24 in Ratio Between Trail Making Test (TMT)- Part B and TMT- Part A Scores
timeFrame: Baseline up to Week 24
measure: Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score
timeFrame: Baseline up to Week 24
measure: Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score
timeFrame: Baseline up to Week 24
measure: Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating
timeFrame: Baseline up to Week 24
measure: Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating
timeFrame: Baseline up to Week 24
measure: Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS)
timeFrame: Baseline up to Week 24
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline up to 4 weeks after the last dose of study drug (up to 28 weeks)
measure: Apparent Clearance of Basmisanil at Steady State (CL/F,ss)
timeFrame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
measure: Apparent Volume of Distribution of Basmisanil at Steady State (Vz/F,ss)
timeFrame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
measure: Area Under the Curve of Basmisanil at Steady State (AUC,ss)
timeFrame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
measure: Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss)
timeFrame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group Inc.
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest, LLC
state: Arkansas
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Glendale
country: United States
facility: California Clinical Trials
state: California
city: Long Beach
country: United States
facility: Alliance for Wellness, dba Alliance for Research
state: California
city: National City
country: United States
facility: Synergy Clinical Research
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Pico Rivera
country: United States
facility: CNRI - Los Angeles, LLC
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research, LLC
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network Inc.
state: California
city: New Haven
country: United States
facility: Yale School of Medicine - CT Mental Health Center (CMHC) - Schizophrenia Research Clinic
state: Connecticut
city: Largo
country: United States
facility: Vantage Clinical Trials
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Maitland
country: United States
facility: Meridien Research
state: Florida
city: Miami
country: United States
facility: University of Miami Dept of Psychiatry
state: Florida
city: North Miami
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Shreveport
country: United States
facility: Booker, J. Gary, MD, APMC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Clinical Research, LLC
state: Louisiana
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Arch Clinical Trials, LLC
state: Missouri
city: Saint Louis
country: United States
facility: St Louis Clinical Trials
state: Missouri
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: New York
country: United States
facility: Manhattan Psychiatric Center; Psychopharmacology Research Unit
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Garland
country: United States
facility: Pillar Clinical Research LLC
state: Texas
city: Irving
country: United States
facility: University Hills Clinical Research - Irving;Office of Dr. Knesevich
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: