SchizophreniaPhase 2NCT00734435
Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects
A Phase 2 study testing zonisamide SR plus olanzapine in people with Schizophrenia and Schizoaffective Disorder, run by Orexigen Therapeutics, Inc at 9 sites in United States.
Trial summary
The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa) Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- What is being tested?
- zonisamide SR plus olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2008to Dec 2008
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects,18-55 years of age
- Outpatients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder
- Body mass index (BMI) between 22-35 kg/m2 (inclusive)
- Negative serum pregnancy test in women of child-bearing potential
- If women of child-bearing potential, must be non-lactating and agree to use an acceptable form of contraception, which in all cases, includes one type of barrier method, throughout the study period and for 30 days after discontinuation of study drug
- Subject requires a change in antipsychotic treatment and olanzapine is deemed by the Investigator to be a reasonable antipsychotic treatment choice
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- No clinically significant abnormality on ECG
- No clinically significant laboratory abnormality
- Negative urine drug screen
- Must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule
- Must be able to read and understand English
Who cannot join
- Diagnosis of substance dependence within the 6 months prior to randomization
- diagnosis of substance abuse (except for nicotine and caffeine) within the 3 months prior to randomization
- Suicidal behavior or ideation within 3 months prior to randomization, or any current suicidal ideation or intent
- Presence of dementia or other organic brain syndrome
- Serious or unstable medical illnesses
- Known, uncorrected narrow-angle glaucoma
- Diagnosis of eating disorder as defined by DSM-IV within 6 months prior to randomization
- Require treatment with any typical or atypical antipsychotic in addition to olanzapine
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Florida Clincal Research Center
Bradenton, Florida, 34208
Brooklyn Medical Institute
Brooklyn, New York, 11223
Larue D. Carter Hospital
Indianapolis, Indiana, 46222
Florida Clinical Research Center
Maitland, Florida, 34208
Synergy Research
National City, California, 91950
American Medical Research
Oak Brook, Illinois, 60523
UCI Medical Center
Orange, California, 92868
CNRI San Diego
San Diego, California, 92126
About this study
Official title: A Proof of Concept, Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Study of Zonisamide Sustained Release (SR) 360 mg Versus Placebo in the Prevention of Weight Gain Associated With Olanzapine Therapy for Psychosis
The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)
- Being tested
- zonisamide SR plus olanzapine, Placebo plus olanzapine
- Keywords
- schizophrenia, schizophreniform, schizoaffective disorder, Zyprexa, olanzapine
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zonisamide SR plus olanzapineDrug
Also called Zyprexa
zonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period)
Placebo plus olanzapineDrug
Also called Zyprexa
Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Zonisamide SR 360 mg and olanzapine 10-20 mg daily Receives: Drug: zonisamide SR plus olanzapine |
| 2 | Placebo comparator | Placebo and olanzapine 10-20 mg daily Receives: Drug: Placebo plus olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in total body weight
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Sponsor Decision- Financial Considerations
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orexigen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Breier, MD, Principal investigator, Larue D. Carter HospitalMohammed Alam, MD, Principal investigator, American Medical ResearchGerald Maguire, MD, Principal investigator, UCI Medical CenterZinoviy Benzar, MD, Principal investigator, Brooklyn Medical InstituteMohammed Bari, MD, Principal investigator, Synergy ResearchTran Johnson, MD, Principal investigator, CNRIEduard Gfeller, MD, Principal investigator, Florida Clinical Research Center, Maitland FloridaAndrew Cutler, MD, Principal investigator, Florida Clinical Research Center, Bradenton Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734435
- Sponsor's protocol ID
- OZ-101
- Status last verified
- Nov 2012
- First submitted
- 12 Aug 2008
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept, Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Study of Zonisamide Sustained Release (SR) 360 mg Versus Placebo in the Prevention of Weight Gain Associated With Olanzapine Therapy for Psychosis
- ClinicalTrials.gov ID
- NCT00734435
- Acronym / sponsor ID
- OZ-101
- Keywords
- schizophrenia, schizophreniform, schizoaffective disorder, Zyprexa, olanzapine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision- Financial Considerations
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Orexigen Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Aug 2008 (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.
The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: zonisamide SR plus olanzapineZonisamide SR 360 mg and olanzapine 10-20 mg daily |
| 2 | Placebo comparator | Drug: Placebo plus olanzapinePlacebo and olanzapine 10-20 mg daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female subjects,18-55 years of age
- Outpatients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder
- Body mass index (BMI) between 22-35 kg/m2 (inclusive)
- Negative serum pregnancy test in women of child-bearing potential
- If women of child-bearing potential, must be non-lactating and agree to use an acceptable form of contraception, which in all cases, includes one type of barrier method, throughout the study period and for 30 days after discontinuation of study drug
Key exclusion criteria (8 listed)
- Diagnosis of substance dependence within the 6 months prior to randomization
- diagnosis of substance abuse (except for nicotine and caffeine) within the 3 months prior to randomization
- Suicidal behavior or ideation within 3 months prior to randomization, or any current suicidal ideation or intent
- Presence of dementia or other organic brain syndrome
- Serious or unstable medical illnesses
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 |
|---|---|---|
| zonisamide SR plus olanzapineAlso: Zyprexazonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period) | Drug | 1 |
| Placebo plus olanzapineAlso: ZyprexaPlacebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period) | Drug | 2 |
Primary outcome
Percentage change in total body weight
Time frame: Baseline to Week 16
Results and safety
The study was stopped early (reason given: Sponsor Decision- Financial Considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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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.
Alan Breier, MD principal investigator
Larue D. Carter Hospital
Mohammed Alam, MD principal investigator
American Medical Research
Gerald Maguire, MD principal investigator
UCI Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zonisamide SR plus olanzapine in people with Schizophrenia and Schizoaffective Disorder, run by Orexigen Therapeutics, Inc at 9 sites in United States.
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 11 inclusion and 8 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: stopped early, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Sponsor Decision- Financial Considerations). Results are not available in the source record.
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?
Percentage change in total body weight (time frame: Baseline to Week 16). 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 29 Nov 2012.