Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia

NCT00469664 | Unknown Phase 4

• 2 other identifiers: 0011099-621
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Cognitive Impairment

Keywords

Schizophrenia; Schizoaffective; Cognitive Impairment; Cognition; Memory; Attention; Concentration

Outcome Measures

Primary Outcomes (1)

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

  Baseline, week 6, week 10

Secondary Outcomes (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

  Baseline, week 6, week 10

Interventions

Guanfacine/Tenex DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead
• Bronx VA Medical Center: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (3)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Bronx VA Medical Center

The Bronx, New York, 10468, United States

Location

Pilgrim Psychiatric Center

W. Brentwood, New York, 11717, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Cognitive Dysfunction

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Joseph I Friedman, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2007
• First Posted: May 4, 2007
• Study Start: February 1, 2000
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 21, 2008

Record last verified: 2008-05

Locations

US (3)