Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BioLineRx, Ltd.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.).
Clareo Health | Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder
