Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
chronic schizophrenia or schizo-affective disorder
Brief summary
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
Interventions
DRUGBL-1020
BL-1020 Low Dose
DRUGBL 1020 High Dose
BL 1020 High Dose
Sponsors
BioLineRx, Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and tolerability of two dose ranges (20-40 mg/day, 30-50 mg/day) of BL-1020 tri-mesylate (free base) in subjects with chronic schizophrenia or schizo-affective disorder | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose | 6 weeks |
| To compare the efficacy of the two dose ranges of BL-1020 | 6 weeks |
| To determine the pharmacokinetics of BL-1020 and its metabolites | 6 weeks |
Countries
Israel, Romania
Outcome results
None listed