Trial Outcomes & Findings for Metabolic Signatures and Biomarkers in Schizophrenia (NCT NCT00466310)

NCT ID: NCT00466310

Last Updated: 2014-07-25

Results Overview

Plasmalogens are a subclass of glycerophospholipids and ubiquitous constituents of cellular membranes and serum lipoproteins. Several neurological disorders show decreased level of plasmalogens.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 71 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2014-07-25

Participant Flow

Unmedicated patients treated for a first psychotic episode (n = 20), and patients treated for psychotic relapse of schizophrenia or schizoaffective disorder(n = 20). Controls who had no personal history of psychotic illness or relatives with psychotic illnesses,(n = 31). Individuals receiving treatment for diabetes or hyperlipidemia were excluded.

Participant milestones

Measure	First Episode Schizophrenics Schizophrenia subjects with no prior episodes	Recurrent Episode Schizophrenics Schizophrenia subjects with at least one prior episode	Healthy Volunteers Fasting blood samples were drawn at baseline from 31 healthy matched controls.
Overall Study STARTED	20	20	31
Overall Study COMPLETED	20	20	31
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metabolic Signatures and Biomarkers in Schizophrenia

Baseline characteristics by cohort

Measure	First Episode Schizophrenics n=20 Participants These are subjects with no prior schizophrenic episodes	Recurrent Episode Schizophrenics n=20 Participants These subjects have had at least one prior schizophrenic episode.	Healthy Volunteers n=31 Participants Fasting blood samples were drawn at baseline from 31 healthy matched controls.	Total n=71 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants	20 Participants n=4 Participants	31 Participants n=27 Participants	71 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	27 years STANDARD_DEVIATION 9.8 • n=93 Participants	36.6 years STANDARD_DEVIATION 12.7 • n=4 Participants	37.9 years STANDARD_DEVIATION 9.1 • n=27 Participants	33.63 years STANDARD_DEVIATION 11.6 • n=483 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	5 Participants n=4 Participants	25 Participants n=27 Participants	37 Participants n=483 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	15 Participants n=4 Participants	6 Participants n=27 Participants	34 Participants n=483 Participants
Region of Enrollment United States	20 participants n=93 Participants	20 participants n=4 Participants	31 participants n=27 Participants	71 participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 17 of the 31 available controls were age and BMI matched to the schizophrenia subjects.

Plasmalogens are a subclass of glycerophospholipids and ubiquitous constituents of cellular membranes and serum lipoproteins. Several neurological disorders show decreased level of plasmalogens.

Outcome measures

Measure	First Episode Schizophrenics n=20 Participants Schizophrenia subjects with no prior episodes	Recurrent Episode Schizophrenics n=20 Participants Schizophrenia subjects with at least one prior episode	Healthy Volunteers n=17 Participants Fasting blood samples were drawn at baseline from 31 healthy matched controls.
Total Plasmalogen Levels in the Lipid Profile	57.65 nmoles/gram Standard Deviation 14.37	59.57 nmoles/gram Standard Deviation 15.87	75 nmoles/gram Standard Deviation 19.17

Adverse Events

First Episode Schizophrenics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Recurrent Episode Schizophrenics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Volunteers

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

Rima Kaddurah-Douk, Associate Professor

DUMC

Phone: 919-684-2611

Email: rima.kaddurah-daouk@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place