Status:
UNKNOWN
Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia
Lead Sponsor:
Research Foundation for Mental Hygiene, Inc.
Collaborating Sponsors:
Bronx VA Medical Center
Icahn School of Medicine at Mount Sinai
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 medic...
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 risp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00469664
Start Date
February 1 2000
End Date
December 1 2008
Last Update
May 21 2008
Active Locations (3)
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1
Mount Sinai Medical Center
New York, New York, United States, 10029
2
Bronx VA Medical Center
The Bronx, New York, United States, 10468
3
Pilgrim Psychiatric Center
W. Brentwood, New York, United States, 11717