Cardio Risk of Acute Schizophrenia Olanzapine Duke

NCT00672464 | Withdrawn Phase 4

• 2 other identifiers: Pro00006916None (investigator sponsored)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Objective: To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk (as estimated by elevation in non-HDL cholesterol levels) during the treatment of schizophrenia with olanzapine. Secondary Objective(s): To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk (as estimated by elevation in triglyceride levels) during the treatment of schizophrenia with olanzapine. To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk (as estimated by C-reactive protein levels) during the treatment of schizophrenia with olanzapine

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective; Cardiovascular; Olanzapine; Metformin; Simvastatin

Outcome Measures

Primary Outcomes (1)

• To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk (as estimated by elevation in non-HDL cholesterol levels) during the treatment of schizophrenia with olanzapine.

  28 days

Secondary Outcomes (1)

• To compare added metformin and/or added simvastatin versus no intervention in reducing or eliminating increased cardiovascular risk during the treatment of schizophrenia with olanzapine.

  28 days

Study Arms (5)

Olanzapine only

ACTIVE COMPARATOR

Newly Admitted Patients with Schizophrenia or Schizoaffective Disorder Who Are Receiving Olanzapine

Drug: Olanzapine

Added Metformin

EXPERIMENTAL

Newly Admitted Patients with Schizophrenia or Schizoaffective Disorder Who Are Receiving Olanzapine with Added Metformin

Drug: Olanzapine; Drug: Metformin

Added Simvastatin

EXPERIMENTAL

Newly Admitted Patients with Schizophrenia or Schizoaffective Disorder Who Are Receiving Olanzapine with Added Simvastatin

Drug: Olanzapine; Drug: Simvastatin

Added Metf. + Simv.

EXPERIMENTAL

Newly Admitted Patients with Schizophrenia or Schizoaffective Disorder Who Are Receiving Olanzapine with Added Metformin and Simvastatin

Drug: Olanzapine; Drug: Metformin; Drug: Simvastatin

Matched Controls

NO INTERVENTION

Matched Control Subjects by age, race, and gender

Interventions

Olanzapine DRUG

Olanzapine zydis 15 mg QHS for 28 days

Added Metf. + Simv.; Added Metformin; Added Simvastatin; Olanzapine only

Metformin DRUG

Metformin capsules will be started at 500 mg twice a day (before breakfast and before dinner) for days 1-3, then 500 mg before breakfast and 1000 mg before dinner for days 4-7, and then 1000 mg twice a day thereafter.

Added Metf. + Simv.; Added Metformin

Simvastatin DRUG

Simvastatin will be started at 10 mg at bed time for the first week and 20 mg at bedtime thereafter.

Added Metf. + Simv.; Added Simvastatin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• We will include patients who come to us free of antipsychotic medication, i.e., patients with chronic schizophrenia (with at least one prior psychiatric hospitalization) who have been off antipsychotic medication for at least 3 weeks and who are newly hospitalized for treatment of an acute psychotic relapse; these patients will be male or female, 18-60 years of age, meet DSM-IV criteria for schizophrenia, and have scores \>=4 on at least two of the PANSS Positive subscale items.

You may not qualify if:

• We will exclude patients whose psychoses are predominantly affective in nature or explainable on the basis of substance abuse or a co-morbid medical condition, patients with diabetes mellitus, epilepsy, mental retardation, or organic mental syndromes, and patients currently taking metformin or a statin.

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

John Umstead Hospital

Butner, North Carolina, 27509, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Olanzapine; Metformin; Simvastatin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines; Organic Chemicals; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Joseph P McEvoy, MD

  Duke University Medical Center, Dep't. Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2008
• First Posted: May 6, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

US (2)