NCT01315002

Brief Summary

The purpose of this study is to test the effects of nicotine on cognition with the following schizophrenia endophenotypes: prepulse inhibition, antisaccades, the continuous performance test, spatial working memory and a verbal memory task. Schizophrenia patients, unaffected first-degree relatives of schizophrenia patients and healthy controls receive transdermal nicotine in a double-blind, placebo-controlled, crossover study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable schizophrenia

Status
completed

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

July 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

January 16, 2015

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

3.7 years

First QC Date

March 14, 2011

Results QC Date

December 18, 2014

Last Update Submit

January 7, 2015

Conditions

Schizophrenia

Keywords

nicotineschizophreniaendophenotype

Outcome Measures

Primary Outcomes (1)

  • Error Percentage in Antisaccade Task

    Three hours after the application of a nicotine or a placebo patch, performance on the antisaccade task is assessed. In the antisaccade task participants visually fixate a central stimulus which is replaced by a sudden onset target that appears at some distance to the left or right. Participants are told to refrain from looking at the peripheral target, and direct their gaze instead in the opposite direction (i.e. they have to make an antisaccade). Participants typically fail to achieve this on a significant number of trials and instead make reflexive glances towards the target (i.e. making a so-called antisaccade error). Error percentage in the antisaccade task is the unit of measure in this task. Error percentage in the antisaccade task = number of antisaccade errors / total number of trials.

    Three hours after patch application

Study Arms (2)

Nicotine Patch

ACTIVE COMPARATOR

Transdermal nicotine patch

Drug: Transdermal nicotine patch

Placebo patch

PLACEBO COMPARATOR

Placebo patch

Drug: Placebo patch

Interventions

Transdermal nicotine patchDRUG

7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)

Also known as: NiQuitin Clear, GlaxoSmithKline Germany
Nicotine Patch
Placebo patchDRUG

Placebo patch

Also known as: band-aid by Fink and Walter GmbH, Germany
Placebo patch

Eligibility Criteria

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

You may qualify if:

  • Patients:
  • Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) diagnosis of schizophrenia
  • age 18-55 years old
  • able to provide informed consent
  • treated with antipsychotic medications at a stable dose for at least 6 weeks
  • normal or corrected to normal vision
  • smokers (Fagerström Test for Nicotine Dependence \> 4)
  • non-smokers (\< 100 cigarettes/lifetime, not having smoked in the past year)
  • Controls:
  • age 18-55 years old
  • able to provide informed consent
  • normal or corrected to normal vision
  • smokers (Fagerström Test for Nicotine Dependence \> 4)
  • non-smokers (\< 100 cigarettes/lifetime, not having smoked in the past year)
  • Unaffected First-Degree Relatives of Schizophrenia Patients:
  • +1 more criteria

You may not qualify if:

  • Patients:
  • substance dependence
  • clinical instability
  • changes in medication in the last 6 weeks
  • anticholinergic medication
  • untreated hypertension
  • cardiovascular disease
  • insulin-dependent diabetes mellitus
  • phaeochromocytoma
  • uncontrolled hyperthyroidism
  • renal or hepatic impairment
  • central nervous system disease
  • pulmonary disease
  • generalised dermatological disorders (neurodermatitis, psoriasis, chronic dermatitis, urticaria, etc.)
  • gastric or intestinal ulcer
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Prof. Dr. Michael Wagner
Organization
University Hospital Bonn, Department of Psychiatry and Psychotherapy
michael.wagner@uni-bonn.de
004922828716377

Study Officials

  • Michael Wagner, Prof. Dr.

    University Hospital, Bonn

    PRINCIPAL INVESTIGATOR

  • Wolfgang Maier, Prof. Dr.

    University Hospital, Bonn

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

July 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 16, 2015

Results First Posted

January 16, 2015

Record last verified: 2015-01