Study of Blood Lactate Levels in Patients Treated With Antipsychotics

NCT01139463 | Completed DMC

• 1 other identifier: 500-03/06-01/74, 2181-147-06
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Movement Disorders; Lactic Acidosis

Keywords

antipsychotics; lactates; side effects

Outcome Measures

Primary Outcomes (3)

• Blood lactate levels

  1 month

• Blood lactate levels

  3 months

• Blood lactate levels

  6 months

Secondary Outcomes (3)

• Extrapyramidal side effects

  1 month

• Extrapyramidal side effects

  3 months

• Extrapyramidal side effects

  6 months

Study Arms (1)

Antipsychotic treatment

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

Interventions

Haloperidol or olanzapine DRUG

Haloperidol tablet - 5 mg twice daily (morning and evening) by mouth Olanzapine tablet - 5 mg twice daily (morning and evening) by mouth

Also known as: Haldol, Olzapin

Antipsychotic treatment

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population consists of patients from the psychiatric inpatient and outpatient sections of a primary care hospital.

You may qualify if:

• Men aged 20 - 50 years
• Not taking any antipsychotic medication 1 month prior to the study
• Diagnosed psychotic disorder

You may not qualify if:

• Female
• Tobacco use
• Diabetes mellitus
• Baseline lactate blood level over 2.0 mmol/L

Sponsors & Collaborators

• University of Split: lead

Study Sites (1)

Split Clinical Hospital Center

Split, 21000, Croatia

Location

Related Publications (1)

• Glavina T, Mrass D, Dodig T, Glavina G, Pranic S, Uglesic B. Blood lactate levels in patients receiving first- or second- generation antipsychotics. Croat Med J. 2011 Feb;52(1):41-7. doi: 10.3325/cmj.2011.52.41.

  PMID: 21328719 DERIVED

MeSH Terms

Conditions

Movement Disorders; Acidosis, Lactic

Interventions

Haloperidol; Olanzapine

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Trpimir Glavina, MD

  University of Split

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 8, 2010
• Study Start: June 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 8, 2010

Record last verified: 2010-06

Locations

CR (1)