Metabolic SyndromeMetSNCT00534183
Metabolic Profile and Anthropometric Changes in Schizophrenia
A study testing Olanzapine, Risperidone and Haloperidol in people with Metabolic Syndrome and Diabetes, run by Central Institute of Psychiatry, Ranchi, India at 1 site in India.
Trial summary
"No clinical differences will be found between the three antipsychotics under study - olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. " Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Metabolic Syndrome, Diabetes, Obesity
- What is being tested?
- Olanzapine, Risperidone and Haloperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,006 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2006to Dec 2006
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-40 years
- Diagnosis of schizophrenia
- Drug naive on admission
Who cannot join
- Other psychiatric co-morbidity
- History of severe physical illness
- Alcohol and substance abuse or dependence
- History of pre-existing diabetes or hypertension
- Family history of hypertension or diabetes
Trial locations and contacts
1 site in 1 country.
About this study
"No clinical differences will be found between the three antipsychotics under study - olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. "
Read the detailed description
we aimed to study the effects of antipsychotics, olanzapine, risperidone and haloperidol on development of metabolic syndrome in a drug naïve population suffering from first episode schizophrenia and compared it with a matched healthy control group. We also aimed to examine the prevalence of metabolic syndrome as defined by the two most widely accepted definitions, the ATP IIIA and the IDF.
- Conditions
- Metabolic Syndrome, Diabetes, Obesity
- Being tested
- Olanzapine, Risperidone, Haloperidol
- Keywords
- Metabolic syndrome, Obesity, Diabetes
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Olanzapine in dose range of 10-20mg
RisperidoneDrug
Risperidone 1-6mg
HaloperidolDrug
Haloperidol 10-20mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Olanzapine Receives: Drug: Olanzapine |
| 2 | Active comparator | Risperidone Receives: Drug: Risperidone |
| 3 | Active comparator | haloperidol Receives: Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of metabolic profile
Measured: 6 weeks
Secondary outcomes (1)
Study of obesity and diabetes
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startJun 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Psychiatry, Ranchi, India
- Sponsor type
- University, hospital or other
- Investigators
- Sahoo Saddichha, DPM, Principal investigator, Central Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534183
- Sponsor's protocol ID
- CIPMETS001
- Acronym
- MetS
- Status last verified
- Sep 2007
- First submitted
- 21 Sep 2007
- Last updated
- 24 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.
PubMed 38958149Saddichha S, Manjunatha N, Ameen S, Akhtar S. Effect of olanzapine, risperidone, and haloperidol treatment on weight and body mass index in first-episode schizophrenia patients in India: a randomized, double-blind, controlled, prospective study. J Clin Psychiatry. 2007 Nov;68(11):1793-8. doi: 10.4088/jcp.v68n1120.
PubMed 18052574
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Profile and Anthropometric Changes in Schizophrenia
- ClinicalTrials.gov ID
- NCT00534183
- Acronym / sponsor ID
- MetS / CIPMETS001
- Conditions
- Metabolic Syndrome, Diabetes, Obesity
- Keywords
- Metabolic syndrome, Obesity, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,006 participants (actual)
- Lead sponsor
- Central Institute of Psychiatry, Ranchi, IndiaUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 24 Sep 2007 (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.
"No clinical differences will be found between the three antipsychotics under study - olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. "
Detailed description
we aimed to study the effects of antipsychotics, olanzapine, risperidone and haloperidol on development of metabolic syndrome in a drug naïve population suffering from first episode schizophrenia and compared it with a matched healthy control group. We also aimed to examine the prevalence of metabolic syndrome as defined by the two most widely accepted definitions, the ATP IIIA and the IDF.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: OlanzapineOlanzapine |
| 2 | Active comparator | Drug: RisperidoneRisperidone |
| 3 | Active comparator | Drug: Haloperidolhaloperidol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-40 years
- Diagnosis of schizophrenia
- Drug naive on admission
Key exclusion criteria (5 listed)
- Other psychiatric co-morbidity
- History of severe physical illness
- Alcohol and substance abuse or dependence
- History of pre-existing diabetes or hypertension
- Family history of hypertension or diabetes
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 |
|---|---|---|
| OlanzapineOlanzapine in dose range of 10-20mg | Drug | 1 |
| RisperidoneRisperidone 1-6mg | Drug | 2 |
| HaloperidolHaloperidol 10-20mg | Drug | 3 |
Primary outcome
Study of metabolic profile
Time frame: 6 weeks
1 secondary outcome
Study of obesity and diabetes
Time frame: 6 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 24 Sep 2007.
- Derived from this study: PubMed 38958149Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.
- Derived from this study: PubMed 18052574Saddichha S, Manjunatha N, Ameen S, Akhtar S. Effect of olanzapine, risperidone, and haloperidol treatment on weight and body mass index in first-episode schizophrenia patients in India: a randomized, double-blind, controlled, prospective study. J Clin Psychiatry. 2007 Nov;68(11):1793-8. doi: 10.4088/jcp.v68n1120.
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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.
Sahoo Saddichha, DPM principal investigator
Central Institute of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olanzapine, Risperidone and Haloperidol in people with Metabolic Syndrome and Diabetes, run by Central Institute of Psychiatry, Ranchi, India at 1 site in India.
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 5 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 24 Sep 2007. 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 India. 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?
Study of metabolic profile (time frame: 6 weeks). 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 NCT00534183, which also lists 2 linked publications.
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 24 Sep 2007.