Study of Blood Lactate Levels in Patients Treated With Antipsychotics

Movement Disorders Clinical Trial

Official title:

Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139463
• Other study ID #: 500-03/06-01/74, 2181-147-06
• Status: Completed
• Phase: N/A
• First received: June 4, 2010
• Last updated: June 7, 2010
• Start date: June 2008
• Est. completion date: October 2009

Study information

• Verified date: June 2010
• Source: University of Split
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acidosis, Lactic
• Lactic Acidosis
• Movement Disorders

Intervention

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

Locations

Country	Name	City	State
Croatia	Split Clinical Hospital Center	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Split

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood lactate levels		1 month	No
Primary	Blood lactate levels		3 months	No
Primary	Blood lactate levels		6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No