NCT01934023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

1.9 years

First QC Date

August 27, 2013

Last Update Submit

August 24, 2015

Conditions

Schizophrenia

Keywords

plasticity, schizophrenia, varenicline, non smokers,

Outcome Measures

Primary Outcomes (1)

  • Change of Paired Associative Stimulation (PAS) induced plasticity from baseline

    Day 3 of weeks 1 and 2

Secondary Outcomes (1)

  • Change of Working memory performance from baseline

    Day 3 of weeks 1 and 2

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

FDA approved smoking cessation medication

Drug: Varenicline

Placebo Sugar Pill

PLACEBO COMPARATOR

sugar pill

Drug: Placebo

Interventions

VareniclineDRUG

Champix (Varenicline) is an approved smoking cessation medication

Also known as: Champix
Varenicline
PlaceboDRUG
Placebo Sugar Pill

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoker or past smoker, abstinent for at least the last 1 year
  • Ability and willingness to speak English
  • Willingness to provide informed consent
  • Adequate hearing and visual capacity, or corrected by visual/ hearing aid, right handedness.
  • Diagnosis of schizophrenia
  • Stable psychotropic drug treatment for at least the past 4 weeks
  • Clinically stable for the past 3 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Tony P George, M.D

    Centre for Addiction Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Schizophrenia Division

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 4, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

CA(1)