This trial is active, not recruiting.

Conditions schizophrenia, schizoaffective disorder, schizophreniform disorder
Treatments varenicline, placebo
Phase phase 4
Sponsor University of Maryland
Collaborator Stanley Medical Research Institute
Start date May 2007
End date May 2010
Trial size 60 participants
Trial identifier NCT00492349, 06TGF-966, HP-00040322


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
varenicline Chantix
Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
(Placebo Comparator)
placebo Placebo
Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks

Primary Outcomes

BPRS, SANS, SDS, neurocognitive and biomarkers, Quality of life, addiction scales, MCCB
time frame: 2 weeks for biomarkers; 8 weeks for all measures

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Varenicline Adjunctive Treatment in Schizophrenia
Principal investigator L. Elliot Hong, M.D.
Description This is a double-blind, placebo controlled clinical trial in schizophrenia patients. Outcome measures include biomarkers and clinical symptoms and functions, and smoking cessation. Neurobiological and cognitive markers will be measured for short term (2 weeks) and longer-term (8 weeks). Current schizophrenia treatments are mostly ineffective against primary negative symptoms and the cognitive and information processing deficits associated with the disorder. Previous research has identified several neurophysiological deficits in schizophrenia that are enduring, frequently occurring before psychosis, and mark the disease liability. These schizophrenia endophenotypes provide important targets for novel treatment development as they represent the core deficits of the disorder. We hypothesize that sustained nicotinic and dopaminergic modulation by varenicline may ameliorate the core neurobiological deficits seen in schizophrenia patients, which would lead to subsequent clinical improvement. Neurobiological and neurocognitive markers and clinical and functional measures will be obtained to determine 1) short-term effect of varenicline on biomarkers; and 2) longer-term improvement in clinical symptoms, smoking cessation, and functions; and how biomarker changes predict these improvements.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by University of Maryland.