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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Cognitive Impairment

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Guanfacine/Tenex
Sponsored by
Research Foundation for Mental Hygiene, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective, Cognitive Impairment, Cognition, Memory, Attention, Concentration

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bronx VA Medical Center
  • Mount Sinai Medical Center
  • Pilgrim Psychiatric Center

Outcomes

Primary Outcome Measures

Spatial Working Memory Test Trail Making Test: Part A and B.

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

Full Information

First Posted
May 2, 2007
Last Updated
May 20, 2008
Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
Bronx VA Medical Center, Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT00469664
Brief Title
Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia
Acronym
Guanfacine
Official Title
A Double Blind Placebo Controlled Study of Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2000 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
Bronx VA Medical Center, Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Cognitive Impairment
Keywords
Schizophrenia, Schizoaffective, Cognitive Impairment, Cognition, Memory, Attention, Concentration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Guanfacine/Tenex
Primary Outcome Measure Information:
Title
Spatial Working Memory Test Trail Making Test: Part A and B.
Time Frame
Baseline, week 6, week 10
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects will be males and females between the ages of 18 and 55. In good general medical health. Have a DSMIV diagnosis of schizophrenia, any subtype, or schizoaffective disorder. Patients who have been diagnosed with other DSMIV Axis I disorders may be included, unless they are actively using illicit substances. Receiving treatment with aripiprazole, olanzapine, quetiapine, and/or risperidone as their antipsychotic medication 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. 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). 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: Have a recent history (within previous year) of serious suicide, homicide, or serious physical violence, or current suicidal or homicidal thoughts Active use of illicit substances. Meet DSM-IV criteria for a current episode of major depression or mania. Have a history of severe head trauma, neurological disorder or medical illness which may contribute to the patient's psychiatric symptoms and cognitive impairment. 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). Receive treatment with other concomitant neuroleptics in addition to risperidone or olanzapine. 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. Are unable to give informed consent. Have a history of developmental disorder or less than an eighth grade reading level. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph I Friedman, MD
Organizational Affiliation
Pilgrim Psychiatric Center, Mount Sinai Medical Center, Bronx VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronx VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Mount Sinai Medical Center
City
NY
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Pilgrim Psychiatric Center
City
W. Brentwood
State/Province
New York
ZIP/Postal Code
11717
Country
United States

12. IPD Sharing Statement

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Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia

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