Efficacy and Safety Study of Escitalopram Augmentation in Treatment Resistant Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00231335
First received: October 3, 2005
Last updated: December 6, 2010
Last verified: March 2006
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Emory University:

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.

Estimated Enrollment: 30
Study Start Date: March 2006
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231335

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

No publications provided

Responsible Party: Dragan Bugarski-Kirola, MD, Emory University
ClinicalTrials.gov Identifier: NCT00231335     History of Changes
Other Study ID Numbers: 408-2005
Study First Received: October 3, 2005
Last Updated: December 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
schizophrenia
depression
anxiety
negative symptoms

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 14, 2014