Study of Blood Lactate Levels in Patients Treated With Antipsychotics

Completed

• Conditions: Movement Disorders; Lactic Acidosis
• Interventions: Drug: Haloperidol or olanzapine

• Registration Number: NCT01139463
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-06
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-06
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-07
• Last Update Submitted: 2010-06-07
• Study First Posted: 2010-06-08
• Last Update Posted: 2010-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antipsychotic treatment	Haloperidol or olanzapine	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.

Primary Outcome Measures

Name	Time	Method
Blood lactate levels	6 months

Secondary Outcome Measures

Name	Time	Method
Extrapyramidal side effects	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.

Trial Locations

Locations (1)

Split Clinical Hospital Center; 🇭🇷 Split, Croatia