Effects of Varenicline on Plasticity in Schizophrenia

NCT01934023

Last updated date
Study Location
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

(Healthy subjects and Scz):

- Non-smoker or past smoker, abstinent for at least the last 1 year

- Females with potential childbearing must have a negative serum pregnancy test at inclusion.

- Ability and willingness to speak English

- Willingness to provide informed consent

- Adequate hearing and visual capacity, or corrected by visual/ hearing aid, right handedness.

INCLUSION Criteria (Scz Only):

- Diagnosis of schizophrenia

- Stable psychotropic drug treatment for at least the past 4 weeks

- Clinically stable for the past 3 months.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

(healthy subjects and SCZ):


- Current smoker or abstinent smoker for less than 1 year


- Current history of drug abuse disorder or current elicit drug use


- Current or past history of neurological disorder


- Current or past history of seizures


- Any metal implants


- Mini Mental Status Examination score of less than 20


- Diagnosis of bipolar disorder or current Major depression episode


- Electroconvulsive Therapy (ECT) within 6 months


- Varenicline hypersensitivity.

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Effects of Varenicline on Plasticity in Schizophrenia
Official Title  ICMJE Effects of Varenicline on Cortical Neuroplasticity and Working Memory in Patients With Schizophrenia and Healthy Controls
Brief Summary This laboratory pilot study will explore the effects of varenicline tartrate on long-term potentiation (LTP)-like mechanisms of (1) the motor cortex and (2) the dorsolateral prefrontal cortex (DLPFC) and working memory in non-smoking patients with schizophrenia and healthy controls using a Paired Associative Stimulation (PAS) method. The present study will use this novel PAS method to evaluate the effects of five doses of varenicline (Champix) 0.5 mg BID treatment on neuroplasticity changes and working memory in 28 non-smokers with schizophrenia and 28 non-smoking controls in a placebo-controlled, double-blinded, cross-over design. The hypothesis is that varenicline will increase LTP-like facilitation of the DLPFC as compared with placebo in patients with schizophrenia, with less or a null effect in healthy controls. Likewise, it is hypothesized that varenicline will specifically improve working memory in patients with schizophrenia as compared with placebo and healthy controls. We Hypothesize that: 1.Patients with Schizophrenia(SCZ) will have reduced cortical LTP and impaired working memory compared to healthy controls 2. Sub-chronic varenicline challenge will attenuate the cortical LTP and working memory deficit in patients with SCZ. 3.Reversal of the cortical LTP deficit by varenicline in patients with SCZ will be associated with improvement in working memory.
Detailed Description The experimental laboratory study will be designed as a randomized, double-blinded, placebo-controlled acute treatment trial. Paired Associative Stimulation (PAS)-induced cortical evoked activity and Working Memory (WM) will be assessed in healthy non-smokers and non-smokers with SCZ, after five doses of varenicline tartrate (0.5 mg/dose) and placebo treatment. PAS will be induced by pairing transcranial magnetic stimulation with peripheral nerve stimulation, 25 msec apart (hence PAS-25). In part 1, motor cortex plasticity will be assessed as changes in motor evoked potential comparing pre to post PAS up tp 120 min after PAS. In part 2, DLPFC evoked cortical activity will be assessed using EEG comparing pre to post PAS. Effects of varenicline and PAS-25 on WM will evaluated using a computerized N-back task, assessed directly before the PAS testing. The whole experimental session will be repeated for each participant twice: once with varenicline tartrate treatment and once with placebo treatment, two weeks apart.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Varenicline
    Champix (Varenicline) is an approved smoking cessation medication
    Other Name: Champix
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Varenicline
    FDA approved smoking cessation medication
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo Sugar Pill
    sugar pill
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2015)
24
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2013)
28
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria (Healthy subjects and Scz):

  • Non-smoker or past smoker, abstinent for at least the last 1 year
  • Females with potential childbearing must have a negative serum pregnancy test at inclusion.
  • Ability and willingness to speak English
  • Willingness to provide informed consent
  • Adequate hearing and visual capacity, or corrected by visual/ hearing aid, right handedness.

INCLUSION Criteria (Scz Only):

  • Diagnosis of schizophrenia
  • Stable psychotropic drug treatment for at least the past 4 weeks
  • Clinically stable for the past 3 months.

Exclusion Criteria (healthy subjects and SCZ):

  • Current smoker or abstinent smoker for less than 1 year
  • Current history of drug abuse disorder or current elicit drug use
  • Current or past history of neurological disorder
  • Current or past history of seizures
  • Any metal implants
  • Mini Mental Status Examination score of less than 20
  • Diagnosis of bipolar disorder or current Major depression episode
  • Electroconvulsive Therapy (ECT) within 6 months
  • Varenicline hypersensitivity.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01934023
Other Study ID Numbers  ICMJE 214-2012
Wi172662 ( Other Grant/Funding Number: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tony George, Centre for Addiction and Mental Health
Study Sponsor  ICMJE Centre for Addiction and Mental Health
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Tony P George, M.DCentre for Addiction Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP