Trial Outcomes & Findings for Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes (NCT NCT00108303)

Last Updated: 2016-01-07

Results Overview

Log of the Odds for Linkage, a standard genetic analysis metric. The number shown as a result is from a polymorphism in the promoter of the gene for the alpha7 nicotinic receptor on chromosome. Its presence in the individuals in this study, considering all three groups in one analysis, is compared to what of P50 sensory gating. P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds. The log of the odds is the common logarithm of the ratio of the odds that the gene polymorphism and P50 sensory gating are associated versus the odds that they are both distributed in the individuals at random. It is similar to the more common chi squared.

Recruitment status

COMPLETED

Target enrollment

538 participants

Primary outcome timeframe

ten years

Results posted on

2016-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Schizophrenia Probands Persons who meet DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder.	Schizophrenia Relatives Subjects who are first degree relatives of subjects in Arm 1.	Controls Subjects who are unrelated to persons with schizophrenia and do not fulfill criteria for schizophrenia themselves.
Overall Study STARTED	179	179	180
Overall Study COMPLETED	179	179	180
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Schizophrenia Probands n=179 Participants Persons who meet DSM-IV criteria for schizophrenia or schizoaffective disorder	Schizophrenia Relatives n=179 Participants Persons who are first degree relatives of persons in Arm 1	Controls n=180 Participants Persons who are not related to persons in Arm 2 and do not have schizophrenia themselves.	Total n=538 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	179 Participants n=5 Participants	179 Participants n=7 Participants	180 Participants n=5 Participants	538 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	42 years n=5 Participants	41 years n=7 Participants	42 years n=5 Participants	42 years n=4 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	85 Participants n=7 Participants	93 Participants n=5 Participants	275 Participants n=4 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	94 Participants n=7 Participants	87 Participants n=5 Participants	263 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	23 Participants n=7 Participants	28 Participants n=5 Participants	72 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=5 Participants	156 Participants n=7 Participants	152 Participants n=5 Participants	466 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) Black or African American	40 Participants n=5 Participants	41 Participants n=7 Participants	40 Participants n=5 Participants	121 Participants n=4 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants	60 Participants n=7 Participants	60 Participants n=5 Participants	181 Participants n=4 Participants
Race (NIH/OMB) More than one race	33 Participants n=5 Participants	33 Participants n=7 Participants	34 Participants n=5 Participants	100 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	30 Participants n=5 Participants	30 Participants n=7 Participants	31 Participants n=5 Participants	91 Participants n=4 Participants
Region of Enrollment United States	179 participants n=5 Participants	179 participants n=7 Participants	180 participants n=5 Participants	538 participants n=4 Participants
Sensory gating ratio	68 percent STANDARD_DEVIATION 12 • n=5 Participants	49 percent STANDARD_DEVIATION 16 • n=7 Participants	34 percent STANDARD_DEVIATION 9 • n=5 Participants	58 percent STANDARD_DEVIATION 12 • n=4 Participants

PRIMARY outcome

Timeframe: ten years

Population: People with schizophrenia and their relatives in families and controls as members of single families were used to establish the log of the odds ratio.

Outcome measures

Outcome measures
Measure	Group 1 n=538 Participants Subjects who receive genetic study.	Schizophrenia Relatives Persons who are siblings or children of someone with schizophrenia	Controls Persons who do not have schizophrenia themselves and whose relatives do not have schizophrenia
Genetic Linkage	5.2 log (odds ratio)	—	—

PRIMARY outcome

Timeframe: 5 years

Population: Schizophrenia probands and relatives and controls.

h squared which ranges from 0 to 1. This number is similar to the more standard Pearson's correlation coefficient, except that the variable, in this case P50 sensory gating, is correlated across the statuses: schizophrenia proband (has the illness), schizophrenia relative (not ill but relative of someone who is), or control (not ill and has no known ill relative, P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds.

Outcome measures

Outcome measures
Measure	Group 1 n=1 Heritability Subjects who receive genetic study.	Schizophrenia Relatives n=1 Heritability Persons who are siblings or children of someone with schizophrenia	Controls n=1 Heritability Persons who do not have schizophrenia themselves and whose relatives do not have schizophrenia
Heritability Coefficient	0.5 coefficient	0.5 coefficient	0.1 coefficient

PRIMARY outcome

Timeframe: 1 day

Population: Probands with schizophrenia, their relatives, and controls. The log of the odds ratio summarizes data from the entire study population.

Log of the ODDS ratio of Linkage divided by the ODDS of no linkage from a maximum likelihood analysis conducted using the statistical program LINKAGE

Outcome measures

Outcome measures
Measure	Group 1 n=179 Participants Subjects who receive genetic study.	Schizophrenia Relatives n=180 Participants Persons who are siblings or children of someone with schizophrenia	Controls n=180 Participants Persons who do not have schizophrenia themselves and whose relatives do not have schizophrenia
Log of the ODDS of Linkage	5.2 units on a log scale	5.2 units on a log scale	1 units on a log scale

Adverse Events

Schizophrenia Probands

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Schizophrenia Relatives

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Freedman

Phone: 3037244940

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place