Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Research Foundation for Mental Hygiene, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Bronx VA Medical Center
Mount Sinai School of Medicine
Information provided by:
Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier:
NCT00469664
First received: May 2, 2007
Last updated: May 20, 2008
Last verified: May 2008
  Purpose

Our overall aim is to determine if the administration of guanfacine in combination with aripiprazole, olanzapine, quetiapine, and/or risperidone is significantly more effective than any of those medications alone in treating some of the cognitive impairment in schizophrenia.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Cognitive Impairment
Drug: Guanfacine/Tenex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Controlled Study of Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Research Foundation for Mental Hygiene, Inc.:

Primary Outcome Measures:
  • Spatial Working Memory Test Trail Making Test: Part A and B. [ Time Frame: Baseline, week 6, week 10 ]

Secondary Outcome Measures:
  • RAVLT,Digit Span Distraction Test,CPT450,Verbal Fluency Test, Wisconsin Card Sorting Test,Stroop Interference Test,Letter-Number Sequencing, Extra Pyramidal Symptom Rating Scale(ESRS),Positive And Negative Symptom Scale [ Time Frame: Baseline, week 6, week 10 ]

Estimated Enrollment: 50
Study Start Date: February 2000
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

The proposed study is a double blind, placebo controlled, parallel designed investigation comparing the effect of one of four atypical antipsychotics (aripiprazole, olanzapine, quetiapine, and/or risperidone), treatment alone to treatment with one of these in addition to treatment with guanfacine to maximum dose of 3.0 mg per day on a cognitive task performance in schizophrenic patients. The study will take place over fourteen weeks. Patients will receive study medication for the last ten weeks of the protocol.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects will be males and females between the ages of 18 and 55.
  2. In good general medical health.
  3. Have a DSMIV diagnosis of schizophrenia, any subtype, or schizoaffective disorder.
  4. Patients who have been diagnosed with other DSMIV Axis I disorders may be included, unless they are actively using illicit substances.
  5. Receiving treatment with aripiprazole, olanzapine, quetiapine, and/or risperidone as their antipsychotic medication
  6. Subjects will demonstrate significant memory impairment by performing at least two standard deviations below normal performance on the California Verbal Learning Test (CVLT). Using subjects with a clear impairment in acquisition and recall will avoid a ceiling effect in this measure.
  7. Subjects will also be required to have at least an 8th grade reading level and/or a full-scale IQ of at least 85 as assessed by the Wide Range Achievement Test (WRAT).
  8. Patients are allowed to be on the following anti-depressant medications: Fluoxetine (PROZAC), Sertraline (ZOLOFT), Paroxetine (PAXIL), Celexa (CITALOPRAM), Busprion (WELLBUTRIN), Venlafaxine (EFFEXOR), and Buspirone (BUSPAR).

Exclusion Criteria:

  1. Have a recent history (within previous year) of serious suicide, homicide, or serious physical violence, or current suicidal or homicidal thoughts
  2. Active use of illicit substances.
  3. Meet DSM-IV criteria for a current episode of major depression or mania.
  4. Have a history of severe head trauma, neurological disorder or medical illness which may contribute to the patient's psychiatric symptoms and cognitive impairment.
  5. Have a medical illness which requires that they take any medication that has CNS activity or which is known to interact with guanfacine (e.g barbiturates, apha-1 antagonists, beta blockers).
  6. Receive treatment with other concomitant neuroleptics in addition to risperidone or olanzapine.
  7. Receive concomitant anticholinergic drugs, or. If the patient receives benzodiazepines, they must be short or intermediate acting (e.g. alprazolam, lorazepam) and they must be held 48 hours prior to cognitive testing. Treatment with mood stabilizers such as lithium and depakote will be allowed for this study. If the patients is receiving treatment with lithium the level must be < 1 meq/l.
  8. Are unable to give informed consent.
  9. Have a history of developmental disorder or less than an eighth grade reading level.
  10. Have a history of bowel obstruction or untreated benign prostatic hypertrophy. Are taking antihypertensive medications of the class of beta-blockers, alpha-1 antagonists, calcium channel blockers, or alpha-2 agonists.
  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: NCT00469664

Locations
United States, New York
Bronx VA Medical Center
Bronx, New York, United States, 10468
Mount Sinai Medical Center
NY, New York, United States, 10029
Pilgrim Psychiatric Center
W. Brentwood, New York, United States, 11717
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Bronx VA Medical Center
Mount Sinai School of Medicine
Investigators
Principal Investigator: Joseph I Friedman, MD Pilgrim Psychiatric Center, Mount Sinai Medical Center, Bronx VA Medical Center
  More Information

No publications provided

Responsible Party: Joseph Friedman, MD, PilgrimPsychiatric Center
ClinicalTrials.gov Identifier: NCT00469664     History of Changes
Other Study ID Numbers: 00110, 99-621
Study First Received: May 2, 2007
Last Updated: May 20, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Research Foundation for Mental Hygiene, Inc.:
Schizophrenia
Schizoaffective
Cognitive Impairment
Cognition
Memory
Attention
Concentration

Additional relevant MeSH terms:
Schizophrenia
Cognition Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Antipsychotic Agents
Guanfacine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antihypertensive Agents
Cardiovascular Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014