Metabolic DisturbanceNCT06326840
Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment
A study testing Metformin in people with Metabolic Disturbance and Hyperprolactinemia, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to explore the potential of metformin in managing olanzapine-induced metabolic disturbance and hyperprolactinemia in patients with schizophrenia. The main questions it aims to answer are: 1. The effect of metformin on olanzapine-induced metabolic disturbance 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Disturbance, Hyperprolactinemia, Schizophrenia
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 May 2010to 10 Jun 2011
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged between 18 and 60 years
- diagnosed with schizophrenia under the Diagnostic and Statistical Manual of Mental Disorders-fourth edition criteria
- had been consistently treated with a stable dose of olanzapine for a minimum of three months
Who cannot join
- Exclusion criteria encompassed any mental disorder other than schizophrenia, ongoing substance abuse, and medical conditions that could interfere with glucoregulatory and endocrine assessment such as diabetes mellitus and other endocrine disorders. Additionally, severe cardiovascular, hepatic, or renal diseases, malignancy, epilepsy, and pregnancy were also reasons for exclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Models of Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment
The goal of this clinical trial is to explore the potential of metformin in managing olanzapine-induced metabolic disturbance and hyperprolactinemia in patients with schizophrenia. The main questions it aims to answer are:
- The effect of metformin on olanzapine-induced metabolic disturbance
- The effect of metformin on olanzapine-induced hyperprolactinemia
Participants will receive metformin 1500 mg/day for 8 weeks and assessments every 2 weeks.
Read the detailed description
The study was conducted in an inpatient setting, with the dosage of olanzapine remaining consistent throughout the study duration. All participants were administered 1500 mg/day of metformin for eight weeks. Vital signs were measured daily. Physical and neurological examinations were carried out on a weekly basis. Every two weeks, all participants underwent an assessment for general psychopathology. Blood samples were collected in the morning after an overnight fast at the beginning of the study and then every two weeks following the commencement of metformin treatment. Serum prolactin levels were determined through electrochemiluminescence immunoassays. Fasting serum levels of glucose, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides were measured using enzymatic colorimetric assays. Serum insulin and leptin levels were measured using electrochemiluminescence immunoassay kits.
- Conditions
- Metabolic Disturbance, Hyperprolactinemia, Schizophrenia
- Being tested
- Metformin
- Keywords
- schizophrenia, olanzapine, metabolic disturbance, prolactin
- Medical subject headings
- Hyperprolactinemia, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
All participants were administered 1500 mg/day of metformin for eight weeks. The trial design is single-group with no masking.
| Study group | Role | What they receive |
|---|---|---|
| metformin intervention | Experimental | All participants were administered 1500 mg/day of metformin for eight weeks. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose level
Glucose level was measured every 2 weeks.
Measured: 8 weeks
prolactin level
Prolactin level was assessed every 2 weeks.
Measured: 8 weeks
Insulin level
insulin level was measured every 2 weeks
Measured: 8 weeks
low-density lipoprotein cholesterol (LDL-C) level
LDL-C level was measured every 2 weeks
Measured: 8 weeks
high-density lipoprotein cholesterol (HDL-C) level
HDL-C level was measured every 2 weeks
Measured: 8 weeks
cholesterol level
cholesterol level was measured every 2 weeks
Measured: 8 weeks
triglycerides level
triglycerides level was measured every 2 weeks
Measured: 8 weeks
leptin level
leptin level was measured every 2 weeks
Measured: 8 weeks
Secondary outcomes (1)
Clinical Global Impression scale
The clinical global impression scale was applied every 2 weeks. The clinical global impression scale is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. The clinical global impression scale is rated from 0 (normal, not at all ill) to 7 (Among the most extremely ill patients).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start31 May 2010
- Primary completion10 Jun 2011
- Study completion10 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisturbanceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University
- Responsible party
- Sponsor
- Investigators
- Mong-Liang Lu, MD, Principal investigator, Taipei Meidcal University-Wan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326840
- Sponsor's protocol ID
- 98107
- Status last verified
- May 2010
- First submitted
- 23 Feb 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Models of Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment
- ClinicalTrials.gov ID
- NCT06326840
- Acronym / sponsor ID
- 98107
- Conditions
- Metabolic Disturbance, Hyperprolactinemia, Schizophrenia
- Keywords
- schizophrenia, olanzapine, metabolic disturbance, prolactin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University
- Study start
- 31 May 2010 (actual)
- Primary completion
- 10 Jun 2011 (actual)
- Study completion
- 10 Jun 2011 (actual)
- First posted
- 22 Mar 2024 (actual)
- 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.
The goal of this clinical trial is to explore the potential of metformin in managing olanzapine-induced metabolic disturbance and hyperprolactinemia in patients with schizophrenia. The main questions it aims to answer are:
- The effect of metformin on olanzapine-induced metabolic disturbance
- The effect of metformin on olanzapine-induced hyperprolactinemia
Participants will receive metformin 1500 mg/day for 8 weeks and assessments every 2 weeks.
Detailed description
The study was conducted in an inpatient setting, with the dosage of olanzapine remaining consistent throughout the study duration. All participants were administered 1500 mg/day of metformin for eight weeks. Vital signs were measured daily. Physical and neurological examinations were carried out on a weekly basis. Every two weeks, all participants underwent an assessment for general psychopathology. Blood samples were collected in the morning after an overnight fast at the beginning of the study and then every two weeks following the commencement of metformin treatment. Serum prolactin levels were determined through electrochemiluminescence immunoassays. Fasting serum levels of glucose, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides were measured using enzymatic colorimetric assays. Serum insulin and leptin levels were measured using electrochemiluminescence immunoassay kits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metformin intervention | Experimental | Drug: MetforminAll participants were administered 1500 mg/day of metformin for eight weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged between 18 and 60 years
- diagnosed with schizophrenia under the Diagnostic and Statistical Manual of Mental Disorders-fourth edition criteria
- had been consistently treated with a stable dose of olanzapine for a minimum of three months
Key exclusion criteria (1 listed)
- Exclusion criteria encompassed any mental disorder other than schizophrenia, ongoing substance abuse, and medical conditions that could interfere with glucoregulatory and endocrine assessment such as diabetes mellitus and other endocrine disorders. Additionally, severe cardiovascular, hepatic, or renal diseases, malignancy, epilepsy, and pregnancy were also reasons for exclusion.
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 |
|---|---|---|
| MetforminAll participants were administered 1500 mg/day of metformin for eight weeks. The trial design is single-group with no masking. | Drug | metformin intervention |
Primary outcome
Glucose level
Time frame: 8 weeks
Glucose level was measured every 2 weeks.
prolactin level
Time frame: 8 weeks
Prolactin level was assessed every 2 weeks.
Insulin level
Time frame: 8 weeks
insulin level was measured every 2 weeks
low-density lipoprotein cholesterol (LDL-C) level
Time frame: 8 weeks
LDL-C level was measured every 2 weeks
high-density lipoprotein cholesterol (HDL-C) level
Time frame: 8 weeks
HDL-C level was measured every 2 weeks
cholesterol level
Time frame: 8 weeks
cholesterol level was measured every 2 weeks
triglycerides level
Time frame: 8 weeks
triglycerides level was measured every 2 weeks
leptin level
Time frame: 8 weeks
leptin level was measured every 2 weeks
1 secondary outcome
Clinical Global Impression scale
Time frame: 8 weeks
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 22 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Mong-Liang Lu, MD principal investigator
Taipei Meidcal University-Wan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Metabolic Disturbance and Hyperprolactinemia, run by Taipei Medical University Hospital at 1 site in Taiwan.
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 1 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 22 Mar 2024. 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 Taiwan. 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?
Glucose level (time frame: 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.