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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01139463
Other study ID # 500-03/06-01/74, 2181-147-06
Secondary ID
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


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
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