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Varenicline Adjunctive Treatment in Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Maryland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
MPRC, University of Maryland
ClinicalTrials.gov Identifier:
NCT00492349
First received: June 26, 2007
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Drug: Varenicline
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Varenicline Adjunctive Treatment in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • BPRS, SANS, SDS, neurocognitive and biomarkers, Quality of life, addiction scales, MCCB [ Time Frame: 2 weeks for biomarkers; 8 weeks for all measures ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Varenicline
Drug: Varenicline
Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
Other Name: Chantix
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo 0.5mg po qd x 7 days then titrated to Placebo 0.5mg po bid x 7 weeks
Other Name: Placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492349

Locations
United States, Maryland
Maryland Psychiatric Research Center
Baltimore, Maryland, United States, 21228
UMB School of Medicine
Baltimore, Maryland, United States, 21201
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Stanley Medical Research Institute
Investigators
Principal Investigator: L. Elliot Hong, M.D. Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
  More Information

No publications provided by University of Maryland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MPRC, L. Elliot Hong, M.D., University of Maryland
ClinicalTrials.gov Identifier: NCT00492349     History of Changes
Other Study ID Numbers: HP-00040322, 06TGF-966
Study First Received: June 26, 2007
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Maryland:
Varenicline
Neurobiology
clinical trial
cognitive deficits
Schizophreniform Disorder

Additional relevant MeSH terms:
Disease
Psychotic Disorders
Schizophrenia
Mental Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014