Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder

BioLineRx

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Schizoaffective Disorder

Treatments

Drug: BL-1020

Drug: BL 1020 High Dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT00480571

BL-1020 II

Details and patient eligibility

About

An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female
18 to 65 years of age, inclusive
meet criteria for chronic (diagnosis established > 1 year ago) schizophrenia with adequate psychotic symptoms as demonstrated by a PANSS total score > 60
current diagnosis of schizophrenia (disorganized type, 295.10; catatonic type, 295.20; paranoid type, 295.30; undifferentiated type, 295.90) or schizoaffective disorder (295.7) in accordance with DSM-IV
Agree to be fully hospitalized until at least Day 14 of the study
Females must be of non-childbearing potential: surgically sterilized (i.e. tubal ligation), have had a hysterectomy prior to the screening phase, or be post-menopausal. Females who have been post-menopausal for more than 12 months but less than 24 months must have a FSH > 40 mU/mL.

Exclusion criteria

Pregnant or lactating women
administration of clozapine within 60 days prior to Baseline
DSM-IV diagnosis of schizophreniform disorder (295.40) or schizophrenia residual sub-type (295.60), or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder
Severity of psychosis rated severe or higher (CGI-S 6 or 7)
Known suicidal risk (modified ISST score>7)
Requiring disallowed concomitant psychotropic medication following enrolment into the study
Current evidence of clinically significant or unstable illness
Clinically significant abnormal laboratory data (e.g. creatinine, AST or ALT greater than 3 x the upper limit of normal, TSH>10 IU) at screening, or any abnormal laboratory values that could interfere with the assessment of safety (e.g. blood cell count, etc.).