Movement Disorders Clinical Trial
Official title:
Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics
Verified date | June 2010 |
Source | University of Split |
Contact | n/a |
Is FDA regulated | No |
Health authority | Croatia: Ethics Committee |
Study type | Observational |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Croatia | Split Clinical Hospital Center | Split |
Lead Sponsor | Collaborator |
---|---|
University of Split |
Croatia,
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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