Efficacy and Safety Study of Escitalopram Augmentation in Treatment Resistant Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00231335
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 7, 2010
Forest Laboratories
Information provided by:
Emory University

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: escitalopram Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Study Completion Date : July 2007

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Meet DSM IV criteria for schizophrenia adn schizoaffective disorder and clinically stable on fixed dose of risperidone or olanzapine for at least 6 weeks.
  2. 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).
  3. 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).
  4. Males and females between 18-55 years of age. No restrictions to recruitment based on race.
  5. 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)
  6. Educational level of at least 10th grade.
  7. 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:

  1. 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.
  2. Extrapyramidal symptoms as defined by score of 4 or more on Simpson-Angus rating scale.
  3. Non-English speaking.
  4. Serious unstable medical illness or any acute medical condition.
  5. Known allergy to any study medication.
  6. Serious suicidal or homicidal risks.
  7. Participation in clinical trial of an investigational drug within 30 days of visit 1.
  8. 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.
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00231335

Sponsors and Collaborators
Emory University
Forest Laboratories
Principal Investigator: Dragan Bugarski-Kirola, MD Emory University

Responsible Party: Dragan Bugarski-Kirola, MD, Emory University Identifier: NCT00231335     History of Changes
Other Study ID Numbers: 408-2005
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: March 2006

Keywords provided by Emory University:
negative symptoms

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents