Weight GainPhase 3NCT00363376
A Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain
A Phase 3 study testing zonisamide and olanzapine in people with Weight Gain, run by Lindner Center of HOPE at 1 site in United States.
Trial summary
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of zonisamide therapy in the prevention of weight gain associated with olanzapine treatment for psychotic or bipolar disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Gain
- What is being tested?
- zonisamide and olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Feb 2011
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria for entering this study will include all of the following:
- Subjects must be 18 years of age or older.
- Subjects must have schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, psychotic disorder NOS, or bipolar I, II, or NOS disorder as defined by DSM-IV-TR criteria.
- Subjects must have a BMI > 22.
- Subjects must sign the Informed Consent Document after the nature of the trial has been fully explained.
- If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, intrauterine device) for at least one month prior to study entry and throughout the study.
- If exposed to olanzapine in the past, subjects must be free of olanzapine for > 3 months prior to randomization to study medication.
Who cannot join
- Criteria for exclusion from this study will be any of the following:
- Subjects with clinically significant suicidal or homicidal ideation.
- Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a psychotic or mood disorder secondary to substance use or a general medical disorder; or a DSM-IV diagnosis of a substance use disorder within the past six months.
- Cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months.
- Subjects who are allergic to or who have demonstrated hypersensitivity to or significant adverse event from olanzapine.
- Subjects who are allergic to or who have demonstrated hypersensitivity to zonisamide.
- Women who are pregnant or nursing.
- Subjects who have received an experimental drug or used an experimental device within 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of zonisamide therapy in the prevention of weight gain associated with olanzapine treatment for psychotic or bipolar disorders.
Read the detailed description
This is a single center, 16-week, randomized, double-blind, placebo-controlled, parallel group, flexible-dose study in 60 outpatients with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, psychotic disorder NOS, or bipolar disorder types I, II, or NOS by DSM-IV-TR criteria43 with a BMI > 22 for whom treatment with olanzapine (5-20 mg/day) would be appropriate as monotherapy or adjunctive therapy. Subjects who meet entry criteria will be randomized to treatment with olanzapine plus zonisamide or olanzapine plus placebo. All subjects will receive Personal Wellness Solution Counseling (http://www.zyprexa.com/hcp/hcp_patient_c_solutions_print.jsp). Both before and after randomization to zonisamide or placebo, patients will not be permitted to have any other major psychotropic medications (antipsychotics, mood stabilizers, antidepressants, or anxiolytics) added to their medication regimens. The primary outcome measure will be change in weight. Secondary outcome measures will include the Young Mania Rating Scale (YMRS),44 the Inventory for Depressive Symptoms (IDS),45 the Positive and Negative Symptoms Scale (PANSS),46 the Clinician Global Improvement (CGI) scale,47 the Binge Eating Scale (BES) 48, BMI, waist circumference, and metabolic variables (fasting lipids, glucose, insulin).
Subjects will be inpatients or outpatients at the time of randomization to olanzapine-zonisamide or olanzapine-placebo. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms, and the presence of treatment-emergent adverse events will be monitored and recorded.
- Conditions
- Weight Gain
- Being tested
- zonisamide, olanzapine, Sugar Pill (placebo)
- Keywords
- olanzapine, zonisamide, weight gain, bipolar disorder, psychotic disorders
- Medical subject headings
- Weight Gain, Bipolar Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zonisamideDrug
Also called Zonegran
Zonisamide will be administered at an initial dose of 100 mg/d for 7 days. Subsequently, zonisamide may be increased, based on clinical response and tolerability, by 100mg/d every 7 days to a maximum of 600 mg/d by the end of the sixth week of treatment. The maximum amount of zonisamide allowed during the study will be 600 mg/day. The minimum amount of zonisamide allowed during the study will be 100 mg/d. Zonisamide will initially be given as a single pm dose, but alterations in dosing will be permitted to reduce side effects (e.g., as BID dosing to reduce nausea).
olanzapineDrug
Also called Zyprexa, Zydis
olanzapine will be administered open-label at 5-20 mg/d titrated to optimize response and minimize side effects
ZonisamideDrug
Also called Zonegran
zonisamide ranging from 100mg to 600mg daily
Sugar Pill (placebo)Drug
sugar pill (placebo) for zonisamide
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Experimental | olanzapine and placebo ("sugar pill") Receives: Drug: zonisamide; Drug: olanzapine; Drug: Sugar Pill (placebo) |
| Zonisamide | Experimental | olanzapine and zonisamide (active drug) Receives: Drug: zonisamide; Drug: olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in weight from baseline to endpoint
Measured: 16 weeks
Secondary outcomes (7)
changes, from baseline to endpoint, in BMI
Measured: 16 weeks
changes, from baseline to endpoint, in abdominal circumference
Measured: 16 weeks
changes, from baseline to endpoint, in metabolic parameters
Measured: 16 weeks
changes, from baseline to endpoint, in clinical global improvement of psychiatric symptoms
Measured: 16 weeks
changes, from baseline to endpoint, in manic symptoms
Measured: 16 weeks
changes, from baseline to endpoint, in depressive symptoms
Measured: 16 weeks
changes, from baseline to endpoint, in psychotic symptoms
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJan 2008
- Primary completionFeb 2011
- Study completionFeb 2011
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 Weight GainStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Susan McElroy, MD, Principal investigator, The Lindner Center of HOPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363376
- Sponsor's protocol ID
- 06-06-14-01
- Other IDs
- F1D-MC-X269
- Status last verified
- Apr 2012
- First submitted
- 9 Aug 2006
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
McElroy SL, Winstanley E, Mori N, Martens B, McCoy J, Moeller D, Guerdjikova AI, Keck PE Jr. A randomized, placebo-controlled study of zonisamide to prevent olanzapine-associated weight gain. J Clin Psychopharmacol. 2012 Apr;32(2):165-72. doi: 10.1097/JCP.0b013e3182488758.
PubMed 22367654
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain
- ClinicalTrials.gov ID
- NCT00363376
- Acronym / sponsor ID
- 06-06-14-01
- Conditions
- Weight Gain
- Keywords
- olanzapine, zonisamide, weight gain, bipolar disorder, psychotic disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, University of Cincinnati
- Study start
- Jan 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Aug 2006 (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 specific aim of this study is to evaluate the efficacy, tolerability, and safety of zonisamide therapy in the prevention of weight gain associated with olanzapine treatment for psychotic or bipolar disorders.
Detailed description
This is a single center, 16-week, randomized, double-blind, placebo-controlled, parallel group, flexible-dose study in 60 outpatients with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, psychotic disorder NOS, or bipolar disorder types I, II, or NOS by DSM-IV-TR criteria43 with a BMI > 22 for whom treatment with olanzapine (5-20 mg/day) would be appropriate as monotherapy or adjunctive therapy. Subjects who meet entry criteria will be randomized to treatment with olanzapine plus zonisamide or olanzapine plus placebo. All subjects will receive Personal Wellness Solution Counseling (http://www.zyprexa.com/hcp/hcp_patient_c_solutions_print.jsp). Both before and after randomization to zonisamide or placebo, patients will not be permitted to have any other major psychotropic medications (antipsychotics, mood stabilizers, antidepressants, or anxiolytics) added to their medication regimens. The primary outcome measure will be change in weight. Secondary outcome measures will include the Young Mania Rating Scale (YMRS),44 the Inventory for Depressive Symptoms (IDS),45 the Positive and Negative Symptoms Scale (PANSS),46 the Clinician Global Improvement (CGI) scale,47 the Binge Eating Scale (BES) 48, BMI, waist circumference, and metabolic variables (fasting lipids, glucose, insulin).
Subjects will be inpatients or outpatients at the time of randomization to olanzapine-zonisamide or olanzapine-placebo. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms, and the presence of treatment-emergent adverse events will be monitored and recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Experimental | Drug: zonisamide, Drug: olanzapine, Drug: Sugar Pill (placebo)olanzapine and placebo ("sugar pill") |
| Zonisamide | Experimental | Drug: zonisamide, Drug: olanzapineolanzapine and zonisamide (active drug) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be 18 years of age or older.
- Subjects must have schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, psychotic disorder NOS, or bipolar I, II, or NOS disorder as defined by DSM-IV-TR criteria.
- Subjects must have a BMI > 22.
- Subjects must sign the Informed Consent Document after the nature of the trial has been fully explained.
- If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, intrauterine device) for at least one month prior to study entry and throughout the study.
Key exclusion criteria (8 listed)
- Subjects with clinically significant suicidal or homicidal ideation.
- Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a psychotic or mood disorder secondary to substance use or a general medical disorder; or a DSM-IV diagnosis of a substance use disorder within the past six months.
- Cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months.
- Subjects who are allergic to or who have demonstrated hypersensitivity to or significant adverse event from olanzapine.
- Subjects who are allergic to or who have demonstrated hypersensitivity to zonisamide.
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 |
|---|---|---|
| zonisamideAlso: ZonegranZonisamide will be administered at an initial dose of 100 mg/d for 7 days. Subsequently, zonisamide may be increased, based on clinical response and tolerability, by 100mg/d every 7 days to a maximum of 600 mg/d by the end of the sixth week of treatment. The maximum amount of zonisamide allowed during the study will be 600 mg/day. The minimum amount of zonisamide allowed during the study will be 100 mg/d. Zonisamide will initially be given as a single pm dose, but alterations in dosing will be permitted to reduce side effects (e.g., as BID dosing to reduce nausea). | Drug | Sugar pill, Zonisamide |
| olanzapineAlso: Zyprexa, Zydisolanzapine will be administered open-label at 5-20 mg/d titrated to optimize response and minimize side effects | Drug | Sugar pill, Zonisamide |
| ZonisamideAlso: Zonegranzonisamide ranging from 100mg to 600mg daily | Drug | Zonisamide |
| Sugar Pill (placebo)sugar pill (placebo) for zonisamide | Drug | Sugar pill |
Primary outcome
change in weight from baseline to endpoint
Time frame: 16 weeks
7 secondary outcomes
changes, from baseline to endpoint, in BMI
Time frame: 16 weeks
changes, from baseline to endpoint, in abdominal circumference
Time frame: 16 weeks
changes, from baseline to endpoint, in metabolic parameters
Time frame: 16 weeks
changes, from baseline to endpoint, in clinical global improvement of psychiatric symptoms
Time frame: 16 weeks
changes, from baseline to endpoint, in manic symptoms
Time frame: 16 weeks
changes, from baseline to endpoint, in depressive symptoms
Time frame: 16 weeks
changes, from baseline to endpoint, in psychotic symptoms
Time frame: 16 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 13 Apr 2012.
- Results publication: PubMed 22367654McElroy SL, Winstanley E, Mori N, Martens B, McCoy J, Moeller D, Guerdjikova AI, Keck PE Jr. A randomized, placebo-controlled study of zonisamide to prevent olanzapine-associated weight gain. J Clin Psychopharmacol. 2012 Apr;32(2):165-72. doi: 10.1097/JCP.0b013e3182488758.
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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.
Susan McElroy, MD principal investigator
The Lindner Center of HOPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zonisamide and olanzapine in people with Weight Gain, run by Lindner Center of HOPE at 1 site 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 7 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: finished, as of the sponsor's last update on 13 Apr 2012. 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 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
change in weight from baseline to endpoint (time frame: 16 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 NCT00363376, 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 13 Apr 2012.