Movement DisordersNCT01139463
Study of Blood Lactate Levels in Patients Treated With Antipsychotics
An observational study of Movement Disorders and Lactic Acidosis, run by University of Split at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Movement Disorders, Lactic Acidosis
- What is being tested?
- Haloperidol or olanzapine
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- Jun 2008to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Study population: The population consists of patients from the psychiatric inpatient and outpatient sections of a primary care hospital.
Who may be able to join
- Men aged 20 - 50 years
- Not taking any antipsychotic medication 1 month prior to the study
- Diagnosed psychotic disorder
Who cannot join
- Female
- Tobacco use
- Diabetes mellitus
- Baseline lactate blood level over 2.0 mmol/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics
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.
Read the detailed 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.
- Conditions
- Movement Disorders, Lactic Acidosis
- Being tested
- Haloperidol or olanzapine
- Keywords
- antipsychotics, lactates, side effects
- Medical subject headings
- Movement Disorders, Acidosis, Lactic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haloperidol or olanzapineDrug
Also called Haldol, Olzapin
Haloperidol tablet - 5 mg twice daily (morning and evening) by mouth Olanzapine tablet - 5 mg twice daily (morning and evening) by mouth
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Haloperidol or olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lactate levels
Measured: 1 month
Blood lactate levels
Measured: 3 months
Blood lactate levels
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 1 month
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.
Measured: 3 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split
- Sponsor type
- University, hospital or other
- Investigators
- Trpimir Glavina, MD, Principal investigator, University of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139463
- Sponsor's protocol ID
- 500-03/06-01/74, 2181-147-06
- Status last verified
- Jun 2010
- First submitted
- 4 Jun 2010
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21328719
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics
- ClinicalTrials.gov ID
- NCT01139463
- Acronym / sponsor ID
- 500-03/06-01/74, 2181-147-06
- Conditions
- Movement Disorders, Lactic Acidosis
- Keywords
- antipsychotics, lactates, side effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of SplitUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antipsychotic treatment | – | Drug: Haloperidol or olanzapinePatients 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The population consists of patients from the psychiatric inpatient and outpatient sections of a primary care hospital.
Key inclusion criteria (3 listed)
- Men aged 20 - 50 years
- Not taking any antipsychotic medication 1 month prior to the study
- Diagnosed psychotic disorder
Key exclusion criteria (4 listed)
- Female
- Tobacco use
- Diabetes mellitus
- Baseline lactate blood level over 2.0 mmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haloperidol or olanzapineAlso: Haldol, OlzapinHaloperidol tablet - 5 mg twice daily (morning and evening) by mouth Olanzapine tablet - 5 mg twice daily (morning and evening) by mouth | Drug | Antipsychotic treatment |
Primary outcome
Blood lactate levels
Time frame: 1 month
Blood lactate levels
Time frame: 3 months
Blood lactate levels
Time frame: 6 months
3 secondary outcomes
Extrapyramidal side effects
Time frame: 1 month
Extrapyramidal side effects
Time frame: 3 months
Extrapyramidal side effects
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
- Derived from this study: PubMed 21328719Glavina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trpimir Glavina, MD principal investigator
University of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders and Lactic Acidosis, run by University of Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lactate levels (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01139463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2010.