Varenicline Adjunctive Treatment in Schizophrenia

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: Stanley Medical Research Institute
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Age 18-60

• DSM-IV Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder

• Clinically stable with no change in antipsychotic medications and increase of daily dose for 4 weeks prior to enrollment

• Sufficient understanding of the study and risks (ESC score 10 or above)

Exclusion Criteria:

• Major medical illness history including, but not limited to, history of heart attack, stroke, TIA (transient ischemic attack)

• History of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration

• DSM-IV diagnosis of substance dependence within 6 months except nicotine and marijuana

• On nicotine replacement therapy (nicotine patch, gum, or nasal spray)

• Uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95)

• EKG of second or third degree atrioventricular (AV) block

• Renal insufficiency with estimated creatinine clearance <40 ml/min

• Women who have positive urine pregnancy tests

• Women who are pregnant, plan to become pregnant, or in breastfeeding