Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder
NCT ID: NCT00480571
Last Updated: 2009-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2007-06-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
BL 1020 low dose
BL-1020
BL-1020 Low Dose
2
BL 1020 High Dose
BL 1020 High Dose
BL 1020 High Dose
Interventions
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BL-1020
BL-1020 Low Dose
BL 1020 High Dose
BL 1020 High Dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.).
18 Years
65 Years
ALL
No
Sponsors
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BioLineRx, Ltd.
INDUSTRY
Responsible Party
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Drug Development Company
Principal Investigators
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Michael Davidson, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Psychiatry, Sheba Medical Center
Locations
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Dept. of Psychiatry, Sheba Medical Center
Tel Litwinsky, , Israel
Spitalul Clinic de Urgenţǎ Militar Central "Dr Carol Davila",
Bucharest, Str Mircea Vulcǎnescu 18, Romania
Countries
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Other Identifiers
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BL-1020 II
Identifier Type: -
Identifier Source: org_study_id
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