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NCT Number: NCT01139463

Study of Blood Lactate Levels in Patients Treated With 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.

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Key information

Conditions

Movement Disorders Acid-Base Imbalance Acidosis Acidosis, Lactic Central Nervous System Diseases Lactic Acidosis Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Split Clinical Hospital Center

Split, 21000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haloperidol or olanzapine

Drug

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

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

    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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

University of Split

Other

Registry information

Official study title

Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 8, 2010
Registry last updated
Jun 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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