Study of Blood Lactate Levels in Patients Treated With Antipsychotics

June 7, 2010 updated by: University Hospital of Split

Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics

Blood lactate levels in patients receiving typical or atypical antipsychotics have not been described in the literature.

The goal of this study is to assess the dynamics of lactate levels in the blood from typical or atypical antipsychotics not confounded by prior antipsychotic treatments, the investigators conducted a prospective study of lactate levels in patients receiving antipsychotic medication. The investigators hypothesized that 6 months of treatment with haloperidol or olanzapine would result in a change in blood lactate levels and extrapyramidal side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to compare the blood lactate levels in patients receiving typical or atypical antipsychotics.

Subjects included sixty patients with psychotic disorder were assigned to treatment for 6 months with haloperidol (typical antipsychotic), N=30 or olanzapine (atypical antipsychotic), N=30. Blood lactate levels, other metabolic parameters, and scores on the extrapyramidal symptom rating scale (ESRS) were assessed.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • Split Clinical Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The population consists of patients from the psychiatric inpatient and outpatient sections of a primary care hospital.

Description

Inclusion Criteria:

  • Men aged 20 - 50 years
  • Not taking any antipsychotic medication 1 month prior to the study
  • Diagnosed psychotic disorder

Exclusion Criteria:

  • Female
  • Tobacco use
  • Diabetes mellitus
  • Baseline lactate blood level over 2.0 mmol/L

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Antipsychotic treatment
Patients were not taking any medications - apart from the prescribed antipsychotic - for a period of 1 month prior to the study with psychotic relapse or newly diagnosed psychotic disorder were recruited from psychiatric inpatient and outpatient clinics of the Split Clinical Hospital.
Drug: Haloperidol or olanzapine
Haloperidol tablet - 5 mg twice daily (morning and evening) by mouth Olanzapine tablet - 5 mg twice daily (morning and evening) by mouth
Other Names:
  • Haldol
  • Olzapin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood lactate levels
Time Frame: 1 month
1 month
Blood lactate levels
Time Frame: 3 months
3 months
Blood lactate levels
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extrapyramidal side effects
Time Frame: 1 month
The extrapyramidal symptom rating scale (ESRS) was used for assessment of four types of antipsychotic induced movement disorders: parkinsonism, akathisia, dystonia, and tardive dyskinesia referred to as extrapyramidal side effects in this study.
1 month
Extrapyramidal side effects
Time Frame: 3 months
The extrapyramidal symptom rating scale (ESRS) was used for assessment of four types of antipsychotic induced movement disorders: parkinsonism, akathisia, dystonia, and tardive dyskinesia referred to as extrapyramidal side effects in this study.
3 months
Extrapyramidal side effects
Time Frame: 6 months
The extrapyramidal symptom rating scale (ESRS) was used for assessment of four types of antipsychotic induced movement disorders: parkinsonism, akathisia, dystonia, and tardive dyskinesia referred to as extrapyramidal side effects in this study.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Split

Investigators

  • Principal Investigator: Trpimir Glavina, MD, University Hospital of Split

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 4, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 8, 2010

Study Record Updates

Last Update Posted (Estimate)

June 8, 2010

Last Update Submitted That Met QC Criteria

June 7, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 500-03/06-01/74, 2181-147-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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