Study of Blood Lactate Levels in Patients Treated With Antipsychotics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics

Conditions
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Movement Disorders, Lactic Acidosis

Intervention / Treatment
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* Drug: Haloperidol or olanzapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Antipsychotic treatment<br>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<br>* Haloperidol tablet - 5 mg twice daily (morning and evening) by mouth Olanzapine tablet - 5 mg twice daily (morning and evening) by mouth<br>* Other names: Olzapin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lactate levels |  | 1 month | 
| Blood lactate levels |  | 3 months | 
| Blood lactate levels |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month | 
| 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. | 3 months | 
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antipsychotics, lactates, side effects