NCT00466310

Brief Summary

We plan to use a metabolomics lipid platform to map biochemical signatures in unmedicated schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug aripiprazole and compare that to lipid perturbations induced by risperidone. These drugs have inherently different risk for metabolic adverse effects and patients respond to them differently. Metabolic signatures for the drugs capture significant biochemical information that could explain part of the basis for varied drug response within individuals and will highlight pathways implicated in drug action and in disease pathogenesis possibly enabling new drug design strategies. In addition, we will compare patients to healthy controls at baseline in regard lipid profiles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_1 schizophrenia

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 3, 2013

Completed
Last Updated

July 25, 2014

Status Verified

March 1, 2013

Enrollment Period

1.9 years

First QC Date

April 25, 2007

Results QC Date

April 5, 2011

Last Update Submit

July 11, 2014

Conditions

Schizophrenia

Keywords

SchizophreniaMetabolomics

Outcome Measures

Primary Outcomes (1)

  • Total Plasmalogen Levels in the Lipid Profile

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

    Baseline

Study Arms (3)

Aripiprazole for 4 weeks

ACTIVE COMPARATOR

Blood is drawn for baseline. 20 Subjects are randomly assigned to receive Aripiprazole for weeks weeks with a starting dose of 10mg/day and the dose will be titrated to a maximum of 30mg /day based on effectiveness and tolerability. After 4 weeks of treatment, blood will be drawn again for metabolomics.

Drug: Aripiprazole

Risperidone for 4 weeks

ACTIVE COMPARATOR

Blood will be drawn for baseline evaluation. 20 Subjects will be randomly assigned to receive risperidone at a starting dose of 2mg/day, and can be increased to 6mg/day based on response of the subject. After 4 weeks of medication, blood is drawn again.

Drug: Risperidone

Healthy volunteers

OTHER

Fasting blood samples will be drawn from healthy volunteers to match age, race and gender with the research subjects for comparison.

Other: Healthy volunteers

Interventions

AripiprazoleDRUG

Aripiprazole for 4 weeks

Also known as: Abilify
Aripiprazole for 4 weeks
RisperidoneDRUG

Subjects will be randomized to risperidone for 4 weeks

Also known as: Risperdal
Risperidone for 4 weeks
Healthy volunteersOTHER

Healthy volunteers

Healthy volunteers

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years
  • Diagnosis of schizophrenia
  • Actively psychotic
  • No more than a single dose of antipsychotic in the preceding 2 weeks

You may not qualify if:

  • Mental retardation, epilepsy or history of head trauma
  • Substance use disorder that explains the majority of the psychopathology
  • Pregnant or lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Umstead Hospital

Butner, North Carolina, 27509, United States

Location

Related Publications (2)

  • Storey JD, Tibshirani R. Statistical significance for genomewide studies. Proc Natl Acad Sci U S A. 2003 Aug 5;100(16):9440-5. doi: 10.1073/pnas.1530509100. Epub 2003 Jul 25.

    PMID: 12883005BACKGROUND

  • Kaddurah-Daouk R, McEvoy J, Baillie R, Zhu H, K Yao J, Nimgaonkar VL, Buckley PF, Keshavan MS, Georgiades A, Nasrallah HA. Impaired plasmalogens in patients with schizophrenia. Psychiatry Res. 2012 Aug 15;198(3):347-52. doi: 10.1016/j.psychres.2012.02.019. Epub 2012 Apr 16.

    PMID: 22513041RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

AripiprazoleRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPyrimidinonesPyrimidines

Limitations and Caveats

Limited to patients admitted to Psychiatric facility

Results Point of Contact

Title
Rima Kaddurah-Douk, Associate Professor
Organization
DUMC
rima.kaddurah-daouk@duke.edu
919-684-2611

Study Officials

  • Rima Kaddurah-Daouk, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

February 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2011

Last Updated

July 25, 2014

Results First Posted

January 3, 2013

Record last verified: 2013-03

Locations

US(1)