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Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder | Clinical Trials | Clareo Health

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

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

NCT00480571•BioLineRx, Ltd.

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

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.).

Locations (2)

Dept. of Psychiatry, Sheba Medical Center

Tel Litwinsky, Israel

Spitalul Clinic de Urgenţǎ Militar Central "Dr Carol Davila",

Bucharest, Str Mircea Vulcǎnescu 18, Romania

Key Dates

Start Date

June 1, 2007

Primary Completion Date

December 1, 2007

Completion Date

December 1, 2007

Last Updated

July 21, 2009

Enrollment

ESTIMATED participants

Conditions

SchizophreniaSchizoaffective Disorder

Interventions

BL-1020

DRUG

BL 1020 High Dose

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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