Efficacy and Safety Study of Escitalopram Augmentation in Treatment Resistant Schizophrenia

NCT00231335 | Completed Phase 4

• 1 other identifier: 408-2005
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

A primary hypothesis to be explored here is that, given its pharmacodynamic profile and hypothesized mechanisms associated with schizophrenia, escitalopram will, in comparison to placebo, be effective when added to risperidone or olanzapine treated group in reducing the severity of resistant symptoms, particularly existing subsyndromal anxiety and depression.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; depression; anxiety; negative symptoms

Outcome Measures

Primary Outcomes (1)

• Reduction of severity of symptoms defined as decrease of >20% from baseline to final evaluation on the PANSS total score.

Secondary Outcomes (1)

• Changes on depression/anxiety dimensions of PANSS subscales defined as decrease of >20% from baseline to final evaluation.

Interventions

escitalopram DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Meet DSM IV criteria for schizophrenia adn schizoaffective disorder and clinically stable on fixed dose of risperidone or olanzapine for at least 6 weeks.
• Incomplete response to risperidone or olanzapine for at least 6 weeks per subjective report and minimum score on rating instruments (PANSS total \>50 at baseline).
• Current positive and negative symptoms sufficiently severe to require adjuvant treatment despite good compliance and adequate doses of antipsychotic before trial (risperidone 4 to 6mg/day, olanzapine15 to 20mg/day for 4-6 weeks of treatment).
• Males and females between 18-55 years of age. No restrictions to recruitment based on race.
• Able to participate fully in the informed consent process or have legal guardian able to participate in the informed consent process. All prospective research subjects will be screened for decisional capacity using the MacArthur Competence Assessment Tool-Research (MacCAT-CR)
• Educational level of at least 10th grade.
• Score on at least on PANSS psychosis items (P1,P2,P3,P5,or P6)\>4 adn CGI Severity score \>4 at point of maximum severity of illness to date or total PANSS score at baseline assessed as moderate (PANSS total \>50).

You may not qualify if:

• Extrapyramidal symptoms as defined by score of 4 or more on Simpson-Angus rating scale.
• Non-English speaking.
• Serious unstable medical illness or any acute medical condition.
• Known allergy to any study medication.
• Serious suicidal or homicidal risks.
• Participation in clinical trial of an investigational drug within 30 days of visit 1.
• Evidence at screening of any medical conditions including but not limited to: infection, electrolyte abnormality, recent physical trauma, malignancy, autoimmune disorders, endocrine diseases and neurological diseases, history of CNS trauma or active seizure disorder requiring medication and known history of mental retardation.
• Any other condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol.

Sponsors & Collaborators

• Emory University: lead
• Forest Laboratories: collaborator

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Depression; Anxiety Disorders

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dragan Bugarski-Kirola, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 4, 2005
• Study Start: March 1, 2006
• Study Completion: July 1, 2007
• Last Updated: December 7, 2010

Record last verified: 2006-03