Varenicline Adjunctive Treatment in Schizophrenia
1 other identifier
interventional
91
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 schizophrenia
Started May 2007
Typical duration for phase_4 schizophrenia
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 26, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
December 11, 2017
CompletedJanuary 5, 2022
December 1, 2017
3 years
June 26, 2007
April 13, 2017
January 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Hamilton Depression Rating Scale (Ham-D)
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.
Week 8
Memory Saccadic Positional Error, Degrees
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.
Week 8
Predictive Pursuit Gain
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.
Week 8
Maintenance Pursuit Gain
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.
Week 8
Digit Symbol Test
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.
Week 0, Week 2 and Week 8
Conner's Continuous Performance Test (CPT) Detectability Score
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.
Week 0, Week 2 and Week 8
Antisaccade Error Rates
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.
Week 0, Week 2 and Week 8
P50
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.
Week 0, Week 2 and Week 8
Study Arms (2)
1
EXPERIMENTALVarenicline
2
PLACEBO COMPARATORPlacebo
Interventions
Varenicline 0.5mg po qd x 7 days then titrated to Varenicline 0.5mg po bid x 7 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
UMB School of Medicine
Baltimore, Maryland, 21201, United States
University of Maryland Medical System
Baltimore, Maryland, 21201, United States
Maryland Psychiatric Research Center
Baltimore, Maryland, 21228, United States
Related Publications (2)
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PMID: 37142273DERIVEDHong LE, Thaker GK, McMahon RP, Summerfelt A, Rachbeisel J, Fuller RL, Wonodi I, Buchanan RW, Myers C, Heishman SJ, Yang J, Nye A. Effects of moderate-dose treatment with varenicline on neurobiological and cognitive biomarkers in smokers and nonsmokers with schizophrenia or schizoaffective disorder. Arch Gen Psychiatry. 2011 Dec;68(12):1195-206. doi: 10.1001/archgenpsychiatry.2011.83. Epub 2011 Aug 1.
PMID: 21810630DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The small number of nonsmokers in the placebo arm could have led to reduced power and false negatives.
Results Point of Contact
- Title
- L. Elliot Hong, M.D.
- Organization
- University of Maryland
Study Officials
- PRINCIPAL INVESTIGATOR
L. Elliot Hong, M.D.
Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 26, 2007
First Posted
June 27, 2007
Study Start
May 1, 2007
Primary Completion
May 1, 2010
Study Completion
April 1, 2011
Last Updated
January 5, 2022
Results First Posted
December 11, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share