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Varenicline Adjunctive Treatment in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492349
First Posted: June 27, 2007
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
L. Elliot Hong, University of Maryland
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Varenicline Adjunctive Treatment in Schizophrenia

Resource links provided by NLM:


Further study details as provided by L. Elliot Hong, University of Maryland:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (Ham-D) [ Time Frame: Week 8 ]
    Ham-D Total Score (range 0 to 54, higher score is worse). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.

  • Memory Saccadic Positional Error, Degrees [ Time Frame: Week 8 ]
    A saccade is a quick eye movement. Spatial working memory was assessed by memory saccade. Participants were asked to focus on a target while a peripheral cue was flashed. Participants were signaled to look in the direction of the peripheral cue when the central target was removed, and the positional error was calculated as the distance between the saccadic and peripheral target positions. Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.

  • Predictive Pursuit Gain [ Time Frame: Week 8 ]
    Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Participants are asked to track a target with their eyes. Participants may use a predictive mechanism to perform the tracking. The pursuit gain using the predictive mechanism is calculated. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.

  • Maintenance Pursuit Gain [ Time Frame: Week 8 ]
    Pursuit gain is the averaged artifact-free eye velocity divided by target velocity. Eye velocity during the regular eye-tracking period (without foveal stabilization) divided by target velocity was used to calculate the maintenance pursuit gain. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.

  • Digit Symbol Test [ Time Frame: Week 0, Week 2 and Week 8 ]
    Digit symbol test score (0 to no definite upper range, higher score is better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.

  • Conner's Continuous Performance Test (CPT) Detectability Score [ Time Frame: Week 0, Week 2 and Week 8 ]
    Conner's CPT Detectability Score (no set normal range, higher is generally better). Definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.

  • Antisaccade Error Rates [ Time Frame: Week 0, Week 2 and Week 8 ]
    In antisaccade, participants were asked to focus on a central target. When a peripheral cue was presented, participants were asked to look in an equidistant and opposite direction of the peripheral cue. The error rate is calculated as the number of trials in which the participant looked toward the cue, rather than in the opposite direction, divided by the total number of trials. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.

  • P50 [ Time Frame: Week 0, Week 2 and Week 8 ]
    P50 response is a measure of the amplitude of the brain wave in response to a sound, where the positive going amplitude of the brain wave occurring at about 50 milliseconds after the sound. Further definition is fully described in a peer-review journal reported at Arch Gen Psychiatry 2011 Dec;68(12):1195-206.


Enrollment: 91
Study Start Date: May 2007
Study Completion Date: April 2011
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492349


Locations
United States, Maryland
UMB School of Medicine
Baltimore, Maryland, United States, 21201
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
Maryland Psychiatric Research Center
Baltimore, Maryland, United States, 21228
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: L. Elliot Hong, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT00492349     History of Changes
Other Study ID Numbers: HP-00040322
First Submitted: June 26, 2007
First Posted: June 27, 2007
Results First Submitted: April 13, 2017
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by L. Elliot Hong, University of Maryland:
Varenicline
Neurobiology
clinical trial
cognitive deficits
Schizophreniform Disorder

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