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CompletedNCT01139463Updated Jun 8, 2010

Study of Blood Lactate Levels in Patients Treated With Antipsychotics

An observational study in Movement Disorders and Lactic Acidosis, sponsored by University Hospital of Split. Completed at 1 site in Croatia. Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2010-06-08.

Sponsored by University Hospital of Split · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
20 Years to 50 Years
Sex
Male
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Study summary

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.

Read the 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.

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Conditions studied

  • Movement Disorders
  • Lactic Acidosis

Keywords

  • antipsychotics
  • lactates
  • side effects
03

In context

Movement Disorders

320 studies on the registry are indexed under Movement Disorders; 98 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 132 observational studies indexed under Movement Disorders.

Browse Movement Disorders studies →

Lead sponsor

University Hospital of Split is the lead sponsor of 29 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)

Groups and cohorts

  • 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

Interventions

  • DrugHaloperidol or olanzapine

    Haloperidol tablet - 5 mg twice daily (morning and evening) by mouth Olanzapine tablet - 5 mg twice daily (morning and evening) by mouth

    Also known as: Haldol, Olzapin

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What researchers measure

Primary outcomes

  1. Blood lactate levels

    Time frame: 1 month

  2. Blood lactate levels

    Time frame: 3 months

  3. Blood lactate levels

    Time frame: 6 months

Secondary outcomes

  1. Extrapyramidal side effects

    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.

    Time frame: 1 month

  2. Extrapyramidal side effects

    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.

    Time frame: 3 months

  3. Extrapyramidal side effects

    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.

    Time frame: 6 months

07

Study locations

1 site
  • Split Clinical Hospital Center
    Split, 21000, Croatia
08

References and documents

Publications

  • Glavina T, Mrass D, Dodig T, Glavina G, Pranic S, Uglesic B. Blood lactate levels in patients receiving first- or second- generation antipsychotics. Croat Med J. 2011 Feb;52(1):41-7. doi: 10.3325/cmj.2011.52.41. PubMed 21328719 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01139463
Lead sponsor
University Hospital of Split
First posted
Jun 8, 2010
Start date
Jun 2008
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Jun 8, 2010

Study contacts

Trpimir Glavina, MD
principal investigator · University Hospital of Split

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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