Study of Blood Lactate Levels in Patients Treated With Antipsychotics

This study has been completed.
Sponsor:
Information provided by:
University of Split
ClinicalTrials.gov Identifier:
NCT01139463
First received: June 4, 2010
Last updated: June 7, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Movement Disorders
Lactic Acidosis
Drug: Haloperidol or olanzapine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics

Resource links provided by NLM:


Further study details as provided by University of Split:

Primary Outcome Measures:
  • Blood lactate levels [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Blood lactate levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Blood lactate levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Extrapyramidal side effects [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.

  • Extrapyramidal side effects [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Extrapyramidal side effects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: June 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139463

Locations
Croatia
Split Clinical Hospital Center
Split, Croatia, 21000
Sponsors and Collaborators
University of Split
Investigators
Principal Investigator: Trpimir Glavina, MD University of Split
  More Information

No publications provided by University of Split

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trpimir Glavina, University of Split
ClinicalTrials.gov Identifier: NCT01139463     History of Changes
Other Study ID Numbers: 500-03/06-01/74, 2181-147-06
Study First Received: June 4, 2010
Last Updated: June 7, 2010
Health Authority: Croatia: Ethics Committee

Keywords provided by University of Split:
antipsychotics
lactates
side effects

Additional relevant MeSH terms:
Acidosis
Acidosis, Lactic
Movement Disorders
Acid-Base Imbalance
Metabolic Diseases
Central Nervous System Diseases
Nervous System Diseases
Haloperidol
Olanzapine
Haloperidol decanoate
Antipsychotic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 23, 2014