ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Blood Lactate Levels in Patients Treated With Antipsychotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01139463
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : June 8, 2010
Sponsor:
Information provided by:
University Hospital of Split

Brief 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.


Condition or disease Intervention/treatment
Movement Disorders Lactic Acidosis Drug: Haloperidol or olanzapine

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
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics
Study Start Date : June 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139463


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

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
First Posted: June 8, 2010    Key Record Dates
Last Update Posted: June 8, 2010
Last Verified: June 2010

Keywords provided by University Hospital of Split:
antipsychotics
lactates
side effects

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