Clinical trial NCT00148447: The Efficacy of Escitalopram for Negative Symptoms in Schizophrenia
Official title: Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: negative symptoms
depression
ssri
schizophrenia
Lead sponsor: BeerYaakov Mental Health Center
Sponsor class: OTHER_GOV
Collaborators: name: Lundbeck Israel
First posted: 2005-09-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: negative symptoms
measure: social function
Secondary outcomes:
measure: positive symptoms
measure: Clinical Global Impression (CGI)
measure: depression
Other outcomes:
Locations:
city: Beer Yaakov
country: Israel
facility: Iulian Iancu
Study officials:
affiliation: Beer Yaakov Mental Health Center
name: Iulian Iancu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beer Yaakov Mental Health Center
name: Moshe Kotler, M.D.
role: STUDY_CHAIR
References:
citation: Friedman JI, Ocampo R, Elbaz Z, Parrella M, White L, Bowler S, Davis KL, Harvey PD. The effect of citalopram adjunctive treatment added to atypical antipsychotic medications for cognitive performance in patients with schizophrenia. J Clin Psychopharmacol. 2005 Jun;25(3):237-42. doi: 10.1097/01.jcp.0000161499.58266.51.