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Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia (Guanfacine)

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ClinicalTrials.gov Identifier: NCT00469664
Recruitment Status : Unknown
Verified May 2008 by Research Foundation for Mental Hygiene, Inc..
Recruitment status was:  Active, not recruiting
First Posted : May 4, 2007
Last Update Posted : May 21, 2008
Sponsor:
Collaborators:
Bronx VA Medical Center
Icahn School of Medicine at Mount Sinai
Information provided by:
Research Foundation for Mental Hygiene, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Cognitive Impairment Drug: Guanfacine/Tenex Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Controlled Study of Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia
Study Start Date : February 2000
Estimated Primary Completion Date : August 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): 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
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Joseph I Friedman, MD Pilgrim Psychiatric Center, Mount Sinai Medical Center, Bronx VA Medical Center

Responsible Party: Joseph Friedman, MD, PilgrimPsychiatric Center
ClinicalTrials.gov Identifier: NCT00469664     History of Changes
Other Study ID Numbers: 00110
99-621
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Schizophrenia
Cognitive Dysfunction
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Antipsychotic Agents
Guanfacine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action