Clinical Trial: Study of Blood Lactate Levels in Patients Treated With Antipsychotics

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.


Sponsor: University Hospital of Split

Current Primary Outcome:

  • Blood lactate levels [ Time Frame: 1 month ]
  • Blood lactate levels [ Time Frame: 3 months ]
  • Blood lactate levels [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Extrapyramidal side effects [ Time Frame: 1 month ]
    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.
  • Extrapyramidal side effects [ Time Frame: 3 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.
  • Extrapyramidal side effects [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: University Hospital of Split

Dates:
Date Received: June 4, 2010
Date Started: June 2008
Date Completion:
Last Updated: June 7, 2010
Last Verified: June 2010