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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Basmisanil
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Woodland International Research Group Inc.
  • Woodland Research Northwest, LLC
  • ProScience Research Group
  • Collaborative Neuroscience Network, Inc.
  • California Clinical Trials
  • Alliance for Wellness, dba Alliance for Research
  • Synergy Clinical Research
  • Pacific Research Partners, LLC
  • NRC Research Institute
  • CNRI - Los Angeles, LLC
  • Artemis Institute for Clinical Research, LLC
  • Collaborative Neuroscience Network Inc.
  • Yale School of Medicine - CT Mental Health Center (CMHC) - Schizophrenia Research Clinic
  • Vantage Clinical Trials
  • Innovative Clinical Research, Inc.
  • Meridien Research
  • University of Miami Dept of Psychiatry
  • Behavioral Clinical Research, Inc.
  • iResearch Atlanta
  • Alexian Brothers Center for Psychiatric Research
  • Community Clinical Research Center
  • Booker, J. Gary, MD, APMC
  • Louisiana Clinical Research, LLC
  • CBH Health
  • Boston Medical Center
  • Arch Clinical Trials, LLC
  • St Louis Clinical Trials
  • Hassman Research Institute
  • Neurobehavioral Research, Inc.
  • Manhattan Psychiatric Center; Psychopharmacology Research Unit
  • Finger Lakes Clinical Research
  • Neuro-Behavioral Clinical Research, Inc.
  • University Hospitals
  • Midwest Clinical Research Center
  • Pillar Clinical Research LLC
  • University Hills Clinical Research - Irving;Office of Dr. Knesevich
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Basmisanil 80mg BID

Basmisanil 240mg BID

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Change From Baseline to Week 24 in MCCB Cognitive Domain Scores
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.
Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score
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.
Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score
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.
Change From Baseline to Week 24 in Ratio Between Trail Making Test (TMT)- Part B and TMT- Part A Scores
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.
Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score
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.
Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score
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.
Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating
Values for the CGI-S Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment.
Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating
Values for the CGI-I Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment.
Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS)
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.
Percentage of Participants With Adverse Events (AEs)
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.
Apparent Clearance of Basmisanil at Steady State (CL/F,ss)
Population PK model estimated apparent oral clearance of Basmisanil at steady-state.
Apparent Volume of Distribution of Basmisanil at Steady State (Vz/F,ss)
Population PK model estimated apparent volume of distribution of Basmisanil at steady-state.
Area Under the Curve of Basmisanil at Steady State (AUC,ss)
Population PK model estimated AUC of Basmisanil at steady-state.
Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss)
Population PK model estimated maximum plasma concentration of Basmisanil at steady-state (ss).

Full Information

First Posted
November 1, 2016
Last Updated
January 21, 2021
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02953639
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2016 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks.
Arm Title
Basmisanil 80mg BID
Arm Type
Experimental
Arm Description
Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks.
Arm Title
Basmisanil 240mg BID
Arm Type
Experimental
Arm Description
Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Basmisanil
Intervention Description
Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants received matching Placebo to Basmisanil, as per the dosing schedules described above.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 24 in MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score
Description
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.
Time Frame
Baseline up to Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 24 in MCCB Cognitive Domain Scores
Description
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.
Time Frame
Baseline up to Week 24
Title
Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Verbal Paired Associates (WMS IV-PAL) Score
Description
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.
Time Frame
Baseline up to Week 24
Title
Change From Baseline to Week 24 in Wechsler Memory Scale Fourth Edition, Logical Memory Test (WMS IV-LM) Score
Description
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.
Time Frame
Baseline up to Week 24
Title
Change From Baseline to Week 24 in Ratio Between Trail Making Test (TMT)- Part B and TMT- Part A Scores
Description
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.
Time Frame
Baseline up to Week 24
Title
Change From Baseline to Week 24 in Personal and Social Performance (PSP) Total Score
Description
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.
Time Frame
Baseline up to Week 24
Title
Change From Baseline to Week 24 in Schizophrenia Cognition Rating Scale (SCoRS) Total Score
Description
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.
Time Frame
Baseline up to Week 24
Title
Change From Baseline to Week 24 in Clinical Global Impression Severity (CGI-S) Rating
Description
Values for the CGI-S Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment.
Time Frame
Baseline up to Week 24
Title
Change From Baseline to Week 24 in Clinical Global Impression Improvement (CGI-I) Rating
Description
Values for the CGI-I Scale are encoded by the numerical values from 1 to 7 respectively. Higher numerical values represent greater impairment.
Time Frame
Baseline up to Week 24
Title
Change From Baseline to Week 24 in Schizophrenia Quality of Life Scale (SQLS)
Description
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.
Time Frame
Baseline up to Week 24
Title
Percentage of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Baseline up to 4 weeks after the last dose of study drug (up to 28 weeks)
Title
Apparent Clearance of Basmisanil at Steady State (CL/F,ss)
Description
Population PK model estimated apparent oral clearance of Basmisanil at steady-state.
Time Frame
Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Title
Apparent Volume of Distribution of Basmisanil at Steady State (Vz/F,ss)
Description
Population PK model estimated apparent volume of distribution of Basmisanil at steady-state.
Time Frame
Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Title
Area Under the Curve of Basmisanil at Steady State (AUC,ss)
Description
Population PK model estimated AUC of Basmisanil at steady-state.
Time Frame
Pre-dose (hour 0) in Days 7, 14, 42, 84, 168
Title
Maximum Plasma Concentration of Basmisanil at Steady State (Cmax,ss)
Description
Population PK model estimated maximum plasma concentration of Basmisanil at steady-state (ss).
Time Frame
Pre-dose (hour 0) in Days 7, 14, 42, 84, 168

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Woodland International Research Group Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland Research Northwest, LLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
California Clinical Trials
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Alliance for Wellness, dba Alliance for Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Synergy Clinical Research
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Pacific Research Partners, LLC
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
CNRI - Los Angeles, LLC
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Artemis Institute for Clinical Research, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Collaborative Neuroscience Network Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Yale School of Medicine - CT Mental Health Center (CMHC) - Schizophrenia Research Clinic
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Vantage Clinical Trials
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Innovative Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Meridien Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of Miami Dept of Psychiatry
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Behavioral Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Community Clinical Research Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46060
Country
United States
Facility Name
Booker, J. Gary, MD, APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104-2136
Country
United States
Facility Name
Louisiana Clinical Research, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71115
Country
United States
Facility Name
CBH Health
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Arch Clinical Trials, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
St Louis Clinical Trials
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Manhattan Psychiatric Center; Psychopharmacology Research Unit
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Pillar Clinical Research LLC
City
Garland
State/Province
Texas
ZIP/Postal Code
75042
Country
United States
Facility Name
University Hills Clinical Research - Irving;Office of Dr. Knesevich
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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