Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia

Schizophrenia Clinical Trial

— Guanfacine  

Official title:

A Double Blind Placebo Controlled Study of Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00469664
• Other study ID #: 00110
• Secondary ID: 99-621
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 2, 2007
• Last updated: May 20, 2008
• Start date: February 2000
• Est. completion date: December 2008

Study information

• Verified date: May 2008
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Guanfacine/Tenex

Locations

Country	Name	City	State
United States	Bronx VA Medical Center	Bronx	New York
United States	Mount Sinai Medical Center	NY	New York
United States	Pilgrim Psychiatric Center	W. Brentwood	New York

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatial Working Memory Test Trail Making Test: Part A and B.		Baseline, week 6, week 10
Secondary	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