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

January 21, 2021 updated by: Hoffmann-La Roche

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
214

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group Inc.
      • Rogers, Arkansas, United States, 72758
        • Woodland Research Northwest, LLC
    • California
      • Culver City, California, United States, 90230
        • Proscience Research Group
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, Inc.
      • Glendale, California, United States, 91206
        • California Clinical Trials
      • Long Beach, California, United States, 90807
        • Alliance for Wellness, dba Alliance for Research
      • National City, California, United States, 91950
        • Synergy Clinical Research
      • Oakland, California, United States, 94607
        • Pacific Research Partners, LLC
      • Orange, California, United States, 92868
        • NRC Research Institute
      • Pico Rivera, California, United States, 90660
        • CNRI - Los Angeles, LLC
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research, LLC
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience Network Inc.
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale School of Medicine - CT Mental Health Center (CMHC) - Schizophrenia Research Clinic
    • Florida
      • Largo, Florida, United States, 33770
        • Vantage Clinical Trials
      • Lauderhill, Florida, United States, 33319
        • Innovative Clinical Research, Inc.
      • Maitland, Florida, United States, 32751
        • Meridien Research
      • Miami, Florida, United States, 33136
        • University of Miami Dept of Psychiatry
      • North Miami, Florida, United States, 33161
        • Behavioral Clinical Research, Inc.
    • Georgia
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Center for Psychiatric Research
    • Indiana
      • Anderson, Indiana, United States, 46060
        • Community Clinical Research Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71104-2136
        • Booker, J. Gary, MD, APMC
      • Shreveport, Louisiana, United States, 71115
        • Louisiana Clinical Research, LLC
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Boston Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63118
        • Arch Clinical Trials, LLC
      • Saint Louis, Missouri, United States, 63141
        • St Louis Clinical Trials
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc.
      • New York, New York, United States, 10035
        • Manhattan Psychiatric Center; Psychopharmacology Research Unit
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
    • Ohio
      • Canton, Ohio, United States, 44718
        • Neuro-Behavioral Clinical Research, Inc.
      • Cleveland, Ohio, United States, 44106
        • University Hospitals
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
    • Texas
      • Garland, Texas, United States, 75042
        • Pillar Clinical Research LLC
      • Irving, Texas, United States, 75062
        • University Hills Clinical Research - Irving;Office of Dr. Knesevich
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.
Drug: Placebo
Participants received matching Placebo to Basmisanil, as per the dosing schedules described above.
Experimental: Basmisanil 80mg BID
Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.
Drug: Basmisanil
Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.
Experimental: Basmisanil 240mg BID
Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.
Drug: Basmisanil
Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline up to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 24 in MCCB Cognitive Domain Scores
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). 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 T-score represents lower impairment.
Baseline up to Week 24
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
The Paired Associates Learning (PAL I and II) of the WMS-IV (Wechsler Memory Scale Fourth edition) is a test of verbal learning and memory that requires the participant to learn novel word pairs. The participant learns the word pairs across learning trials and is asked to recall them immediately (PAL I) or after a 30-minute delay (PAL II). Data is presented here for 3 Scores: VPA I total raw score, VPA II total raw score and VPA II Recognition total raw score. The total raw score ranges for these 3 Scores are 0 to 56, 0 to 14 and 0 to 40 respectively, with larger total raw scores indicating better performance.
Baseline up to Week 24
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
Logical memory (LM) assesses narrative memory under free-recall conditions. Two short stories are presented orally. The examinee is asked to retell each story from memory immediately after hearing it (LM I). In the delayed condition (LM II), the examinee is asked to retell both stories from the immediate condition (delayed free recall). Data is presented here for 2 Scores: LM I total raw score and LM II total raw score. The total raw score range is from 0 to 50 with larger total raw scores indicating better performance.
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
Time Frame: Baseline up to Week 24
The TMT consists of two parts: Trail Making Part A, which is a part of the standard MCCB and Trail Making Part B additionally included in this study. Circles containing numbers (Part A) or both numbers and letters (Part B) must be sequentially connected. The difference (ratio) in performance between Part A and Part B reflects executive processes and will be used to assess executive functioning including cognitive set shifting abilities and data for this ratio is presented here. Smaller ratio values, hence decreases from baseline (TMT-B/TMT-A ratio values below 1) indicate higher executive functioning capabilities.
Baseline up to Week 24
Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score
Time Frame: Baseline up to Week 24
The PSP Total Score is an integer result in the range of 0 to 100. Larger values, hence increases from baseline in the PSP total score, indicate higher social and personal functioning.
Baseline up to Week 24
Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score
Time Frame: Baseline up to Week 24
The main parameter of interest for the Schizophrenia Cognition Rating Scale (SCoRS) is the SCoRS 'Total Score'. The total score range is from 0 to 80 with lower scores indicating better day-to-day functioning.
Baseline up to Week 24
Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating
Time Frame: Baseline up to Week 24
Values for the CGI-S Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment.
Baseline up to Week 24
Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating
Time Frame: Baseline up to Week 24
Values for the CGI-I Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment.
Baseline up to Week 24
Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS)
Time Frame: Baseline up to Week 24
The SQLS is a patient reported scale consisting of 33 items: 2 domain scores (Cognition & Vitality Score [SQLS-CV] and Psycho-social Score [SQLS-P]) as well as a Total score (SQLS-T) are derived. The overall score range is from 0 to 100. On all scales, higher scores represent a lower quality of life.
Baseline up to Week 24
Percentage of Participants With Adverse Events (AEs)
Time Frame: Baseline up to 4 weeks after the last dose of study drug (up to 28 weeks)
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Baseline up to 4 weeks after the last dose of study drug (up to 28 weeks)
Apparent Clearance of Basmisanil at Steady State (CL/F,ss)
Time Frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Population PK model estimated apparent oral clearance of Basmisanil at steady-state.
Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Apparent Volume of Distribution of Basmisanil at Steady State (Vz/F,ss)
Time Frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Population PK model estimated apparent volume of distribution of Basmisanil at steady-state.
Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Area Under the Curve of Basmisanil at Steady State (AUC,ss)
Time Frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Population PK model estimated AUC of Basmisanil at steady-state.
Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss)
Time Frame: Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Population PK model estimated maximum plasma concentration of Basmisanil at steady-state (ss).
Pre-dose (hour 0) in Days 7, 14, 42, 84, 168

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BP39207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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