Clinical trial NCT00480571: Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: chronic schizophrenia or schizo-affective disorder
Lead sponsor: BioLineRx, Ltd.
Sponsor class: INDUSTRY
First posted: 2007-05-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.).

Primary outcomes:
measure: 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
timeFrame: 6 weeks
Secondary outcomes:
measure: To determine the MTD, the optimal dose escalation schedule, and the maximum tolerated maintenance dose
timeFrame: 6 weeks
measure: To compare the efficacy of the two dose ranges of BL-1020
timeFrame: 6 weeks
measure: To determine the pharmacokinetics of BL-1020 and its metabolites
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Dept. of Psychiatry, Sheba Medical Center
city: Bucharest
country: Romania
facility: Spitalul Clinic de Urgenţǎ Militar Central "Dr Carol Davila",
state: Str Mircea Vulcǎnescu 18
Study officials:
affiliation: Dept. of Psychiatry, Sheba Medical Center
name: Michael Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References: