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Efficacy and Safety Study of Escitalopram Augmentation in Treatment Resistant Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
escitalopram
Sponsored by
Emory University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, depression, anxiety, negative symptoms

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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). Exclusion Criteria: Meets full DSM-IV criteria for current Major Depressive Disorder, Bipolar Disorder, Anxiety Disorder or any other active disorder on Axis I. Present but not past history of substance abuse is exclusion criterion. 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 3, 2005
    Last Updated
    December 6, 2010
    Sponsor
    Emory University
    Collaborators
    Forest Laboratories
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00231335
    Brief Title
    Efficacy and Safety Study of Escitalopram Augmentation in Treatment Resistant Schizophrenia
    Official Title
    The Efficacy and Safety of Escitalopram Augmentation of Risperidone and Olanzapine in Treatment Resistant Schizophrenia: a Double Blind Placebo Controlled Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Emory University
    Collaborators
    Forest Laboratories

    4. Oversight

    5. Study Description

    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.
    Detailed Description
    The objective of this trial is to determine the efficacy and safety of augmenting risperidone or olanzapine with escitalopram for treatment of symptoms of schizophrenia in patients with incomplete response to adequate trials of either of the two antipsychotic medications. To our knowledge, this is the first double blind randomized study designed to examine the potential augmentation benefit of escitalopram combined with a commonly used atypical agent in chronic schizophrenic patients with incomplete response to risperidone or olanzapine. The current proposal offers the possibility to test the efficacy of augmentation treatment in a controlled fashion with clinical and biological variables used as indicators of response and tolerability. From a broader perspective, it would test the hypothesis of potential validity of SSRI augmentation strategy in treatment of resistant symptoms of schizophrenia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Schizoaffective Disorder
    Keywords
    schizophrenia, depression, anxiety, negative symptoms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    escitalopram
    Primary Outcome Measure Information:
    Title
    Reduction of severity of symptoms defined as decrease of >20% from baseline to final evaluation on the PANSS total score.
    Secondary Outcome Measure Information:
    Title
    Changes on depression/anxiety dimensions of PANSS subscales defined as decrease of >20% from baseline to final evaluation.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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). Exclusion Criteria: Meets full DSM-IV criteria for current Major Depressive Disorder, Bipolar Disorder, Anxiety Disorder or any other active disorder on Axis I. Present but not past history of substance abuse is exclusion criterion. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dragan Bugarski-Kirola, MD
    Organizational Affiliation
    Emory University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Efficacy and Safety Study of Escitalopram Augmentation in Treatment Resistant Schizophrenia

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