Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia
Information source: Research Foundation for Mental Hygiene
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder; Cognitive Impairment
Intervention: Guanfacine/Tenex (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Research Foundation for Mental Hygiene Official(s) and/or principal investigator(s):
Joseph I Friedman, MD, Principal Investigator, Affiliation: Pilgrim Psychiatric Center, Mount Sinai Medical Center, Bronx VA Medical Center
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.
Clinical Details
Official title: A Double Blind Placebo Controlled Study of Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Spatial Working Memory Test
Trail Making Test: Part A and B.
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Bronx VA Medical Center, Bronx, New York 10468, United States
Mount Sinai Medical Center, NY, New York 10029, United States
Pilgrim Psychiatric Center, W. Brentwood, New York 11717, United States
Additional Information
Starting date: February 2000
Ending date: December 2008
Last updated: May 20, 2008
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