Effects of Atomoxetine on Cognitive Function in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00420498
First received: January 9, 2007
Last updated: December 11, 2007
Last verified: December 2007
  Purpose

The purpose of this study is to examine the effects of atomoxetine (Strattera™) on prefrontal cognitive functioning in persons with schizophrenia. Secondarily, the effects of atomoxetine on positive and negative symptoms and on cigarette smoking consumption in persons with schizophrenia will be examined.


Condition Intervention Phase
Schizophrenia
Cognition
Smoking
Drug: Atomoxetine (Strattera™)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Atomoxetine on Cognitive Function in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • To examine the effects of atomoxetine (Strattera™) on prefrontal cognitive functioning in persons with schizophrenia.

Secondary Outcome Measures:
  • To examine the effects of atomoxetine on positive and negative symptoms and on cigarette smoking consumption in persons with schizophrenia.

Enrollment: 12
Study Start Date: August 2005
Study Completion Date: September 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between ages 18 and 59;
  • SCID-I for DSM-IV diagnosis of schizophrenia or schizoaffective disorder, and nicotine dependence
  • Smoking at least 15 cigarettes per day, and have expired breath CO level >10 ppm,
  • Be in stable remission from active psychiatric symptomatology, (as judged by trained clinical staff in the PRISM research program) and be on a stable dose of psychiatric medication(s) for the past 3 months
  • No current abuse or dependence of alcohol or other substances of abuse within the past 3 months,
  • Full scale IQ > 80,
  • Presence of definable cognitive deficits of interest including VSWM, CPT, and WCST (e.g. at least one standard deviation below average).
  • Able to give informed consent for participation.

Exclusion Criteria:

  • Meet DSM-IV criteria for other major Axis I disorders besides those specified for each diagnostic group.
  • Current abuse or dependence of alcohol or substances within the last 3 months, and subjects who are methadone maintained will be excluded.
  • Full scale IQ < 80.
  • Unable to give informed consent.
  • Patients who are pregnant or planning on becoming pregnant will not be included in this study.
  • Patients on paroxetine, fluoxetine, and quinidine will be excluded from this study.
  • Are deemed medically unsafe to take atomoxetine, as judged by the study physician. Contraindications to the use of atomoxetine include hypersensitivity to atomoxetine, concurrent use of monoamine oxidase inhibitors (atomoxetine should be avoided during therapy with or within 2 weeks of discontinuing an MAO inhibitor), and patients with narrow angle glaucoma. Precautions would include concomitant administration with CYP 2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) (which would necessitate a dose adjustment with atomoxetine), liver disease (enhanced risk of toxicity; empiric dose reduction is suggested based on clinical response; the drug should be avoided in acute hepatic failure), patients with hypertension, tachycardia, or other cardiovascular or cerebrovascular disease, patients with or at risk of hypotension , patients with urinary retention or bladder dysfunction.
  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: NCT00420498

Locations
United States, Connecticut
Connecticut Mental Health Center, SAC-115
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Kristi A Sacco, Psy.D. Yale School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00420498     History of Changes
Other Study ID Numbers: 27678, NARSAD
Study First Received: January 9, 2007
Last Updated: December 11, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Schizophrenia
Prefrontal Cortical Function
Smoking
Cognition
Positive and Negative Symptoms
Tobacco
Cigarette Smoking
Dopamine

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Atomoxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014