Trial Outcomes & Findings for Nicotine Effects on Endophenotypes of Schizophrenia (NCT NCT01315002)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

121 participants

Primary outcome timeframe

Three hours after patch application

Results posted on

2015-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Nicotine First, Then Placebo Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch) Doses: non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch	Placebo First, Then Nicotine Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch) Doses: non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch
Overall Study STARTED	61	60
Overall Study COMPLETED	56	55
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nicotine Effects on Endophenotypes of Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=121 Participants Includes groups randomized to receive nicotine first and placebo first. Number of all study participants = 121.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	121 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30.23 years STANDARD_DEVIATION 9.26 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants
Region of Enrollment Germany	121 participants n=5 Participants

PRIMARY outcome

Timeframe: Three hours after patch application

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.

Outcome measures

Outcome measures
Measure	Nicotine Patch n=111 Participants Transdermal nicotine patch Transdermal nicotine patch: 7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)	Placebo Patch n=111 Participants Placebo patch Placebo patch: Placebo patch
Error Percentage in Antisaccade Task	22.6 Error Percentage in Antisaccade Task Standard Deviation 17.0	29.1 Error Percentage in Antisaccade Task Standard Deviation 19.1

Adverse Events

Nicotine First, Then Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo First, Then Nicotine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nicotine First, Then Placebo n=61 participants at risk Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch) Doses: non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch	Placebo First, Then Nicotine n=60 participants at risk Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch) Doses: non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch
Gastrointestinal disorders Nausea	3.3% 2/61 • 3 years, 8 months	6.7% 4/60 • 3 years, 8 months
Gastrointestinal disorders Vomiting	4.9% 3/61 • 3 years, 8 months	1.7% 1/60 • 3 years, 8 months

Additional Information

Prof. Dr. Michael Wagner

University Hospital Bonn, Department of Psychiatry and Psychotherapy

Phone: 004922828716377

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place