SchizophreniaPhase 4NCT00486005
Weight Gain Management in Patients With Schizophrenia
A Phase 4 study testing Olanzapine Hydrochloride and Nizatidine in people with Schizophrenia, run by Eli Lilly and Company at 1 site in Brazil.
Trial summary
Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with schizophrenia who have been under treatment with olanzapine for at least two months and evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent adverse events, changes in vital signs, laboratory… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine Hydrochloride and Nizatidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2003to Oct 2003
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, men or women, with age of 18 to 65 years
- Patients must have schizophrenia that meets disease diagnostic criteria as defined in DSM-IV Sections 295.10, 295.20, 295.30, or 295.90 and not to be in a clinically acute phase, in accordance with the judgment of the investigator
- Patients in use of 5 mg/day and 20 mg/day of olanzapine for a period not less than 2 months and not greater than 6 months and that have increased at least 5% of their corporal weight since the beginning of the treatment with olanzapine.
- The individuals must be trustworthy, and have a level of understanding enough to carry out all the tests and examinations demanded for the protocol, to understand the nature of the study and to have signed the informed consent
- Women with potential to become pregnant must be using a medically acceptable and reliable means of birth control.
Who cannot join
- Participation in a clinical study of another drug in investigation within a period of 1 month (30 days) before the entrance in the study (Visit 1)
- People who have used clozapine within a period of 12 months before the beginning of the study
- People with diagnosis of diabetes mellitus types I or II without adjusted clinical control or have initiated the medication use for glycemic control in the last 6 months
- DSM-IV substance (except nicotine and caffeine) dependence within the past 30 days
- Current participation in programs of weight loss
Trial locations and contacts
1 site in 1 country.
Brazil1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Rio de Janeiro
About this study
Official title: Weight Gain Management in Patients With Schizophrenia During Treatment With Olanzapine in Association With Nizatidine
Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with schizophrenia who have been under treatment with olanzapine for at least two months and evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent adverse events, changes in vital signs, laboratory results and extrapyramidal effects.
- Conditions
- Schizophrenia
- Being tested
- Olanzapine Hydrochloride, Nizatidine, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine HydrochlorideDrug
NizatidineDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of olanzapine associated to nizatidine compared to olanzapine associated to placebo to prevent/control weight gain
Secondary outcomes (2)
Compare the effect of olanzapine with nizatidine or placebo evaluated by the average alteration between the groups in cognitive control of appetite, disinhibition and susceptibility to hunger, variation of weight and total punctuation in BPRS
Compare the security of the association of olanzapine with nizatidine and olanzapine and placebo in relation to laboratory values, vital signs, and incidence of extrapyramidal symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startFeb 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486005
- Sponsor's protocol ID
- 7932
- Other IDs
- F1D-BL-HGLA
- Status last verified
- Jun 2007
- First submitted
- 11 Jun 2007
- Last updated
- 13 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Gain Management in Patients With Schizophrenia During Treatment With Olanzapine in Association With Nizatidine
- ClinicalTrials.gov ID
- NCT00486005
- Acronym / sponsor ID
- 7932
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Oct 2003 (actual)
- First posted
- 13 Jun 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.
Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with schizophrenia who have been under treatment with olanzapine for at least two months and evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent adverse events, changes in vital signs, laboratory results and extrapyramidal effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients, men or women, with age of 18 to 65 years
- Patients must have schizophrenia that meets disease diagnostic criteria as defined in DSM-IV Sections 295.10, 295.20, 295.30, or 295.90 and not to be in a clinically acute phase, in accordance with the judgment of the investigator
- Patients in use of 5 mg/day and 20 mg/day of olanzapine for a period not less than 2 months and not greater than 6 months and that have increased at least 5% of their corporal weight since the beginning of the treatment with olanzapine.
- The individuals must be trustworthy, and have a level of understanding enough to carry out all the tests and examinations demanded for the protocol, to understand the nature of the study and to have signed the informed consent
- Women with potential to become pregnant must be using a medically acceptable and reliable means of birth control.
Key exclusion criteria (5 listed)
- Participation in a clinical study of another drug in investigation within a period of 1 month (30 days) before the entrance in the study (Visit 1)
- People who have used clozapine within a period of 12 months before the beginning of the study
- People with diagnosis of diabetes mellitus types I or II without adjusted clinical control or have initiated the medication use for glycemic control in the last 6 months
- DSM-IV substance (except nicotine and caffeine) dependence within the past 30 days
- Current participation in programs of weight loss
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 |
|---|---|---|
| Olanzapine Hydrochloride | Drug | – |
| Nizatidine | Drug | – |
| Placebo | Drug | – |
Primary outcome
Evaluate the effect of olanzapine associated to nizatidine compared to olanzapine associated to placebo to prevent/control weight gain
2 secondary outcomes
Compare the effect of olanzapine with nizatidine or placebo evaluated by the average alteration between the groups in cognitive control of appetite, disinhibition and susceptibility to hunger, variation of weight and total punctuation in BPRS
Compare the security of the association of olanzapine with nizatidine and olanzapine and placebo in relation to laboratory values, vital signs, and incidence of extrapyramidal symptoms
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 13 Jun 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olanzapine Hydrochloride and Nizatidine in people with Schizophrenia, run by Eli Lilly and Company at 1 site in Brazil.
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 5 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 13 Jun 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluate the effect of olanzapine associated to nizatidine compared to olanzapine associated to placebo to prevent/control weight gain. 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 13 Jun 2007.