Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- BeerYaakov Mental Health Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- social function
- Status
- Completed
- Last Updated
- 19 years ago
Overview
Brief Summary
The aim of this study is to evaluate the therapeutic effect of escitalopram in the treatment of negative symptoms in schizophrenia patients in a double-blind placebo-controlled study.
Detailed Description
The aim of this study is to evaluate the therapeutic effect of escitalopram (cipralex) in the treatment of negative symptoms in schizophrenic patients receiving either typical or the newer atypical antipsychotics (olanzapine and risperidone) in a double-blind placebo-controlled study. As there is no drug treatment that is considered as first-line treatment in the treatment of negative symptoms, we thought that the comparison with placebo is plausible. However, it is important to note that the patients will receive the commonly used treatment for their disorder (i.e. antipsychotic medication).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic schizophrenia patients,
- •Age \<60,
- •Medicated,
- •Inpatients and outpatients,on stable doses of antipsychotic medications for at least one month before the study entry.
- •Patients will be clinically stable and free of any additional axis I diagnosis or significant medical illnesses before enrollment into the study.
- •A Positive and Negative Syndrome Scale (PANSS) score of 50 or above will be required for entry to the study.
Exclusion Criteria
- •Comorbidity with mania or major depression,
- •Pregnancy,
- •Lactation,
- •Impaired renal or hepatic function,
- •History of sensitivity to cipramil or to other drugs from the selective serotonin reuptake inhibitor (SSRI) group.
- •Additional exclusion criteria will consist of mental retardation, organic conditions (brain tumors, drug abuse) and severe exacerbation of the psychiatric condition (i.e. suicide attempt, severe psychotic exacerbation) as defined by hospitalization in high-security units, clinical impression and CGI scores of "condition much worsened".
- •Patients will be excluded during the study if they will remove their informed consent.
Outcomes
Primary Outcomes
social function
negative symptoms
Secondary Outcomes
- positive symptoms
- Clinical Global Impression (CGI)
- depression