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

Investigator: Dante Durand

Institutional Protocol #: 20160898

National Clinical Trials Identifier: NCT02953639

Funding Agency/Sponsor: ROCHE PHARM

Division: Psychiatry

Therapeutic Area: Other

Phase: N/A

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 7/11/2017


Purpose/Abstract:


This multicenter study will assess 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 ( score
- 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 <70 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


Gender: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Gabriela Vargas, Project Manager, Research Support
(305) 243 2708
gvargas3@miami.edu

Back    


E-mail a Friend