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Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine

Primary Purpose

Bipolar Disorder, Weight Gain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Topiramate

Placebo

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Weight Gain

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients, ages 10-18 years.
Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.
Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) bipolar disorder, type I and currently display an acute manic or mixed episode as determined by K-SADS (Geller et al 2000).
Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16.
Subjects should be fluent in English.

Exclusion Criteria:

Female patients who are either pregnant or lactating.
Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
Any history of current or past diabetes that has been treated with pharmacological intervention.
Neurological disorders including epilepsy, stroke, or severe head trauma.
Clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices. Clinically abnormal ECG.
Manic or mixed episode due to a general medical condition or substance-induced mania (DSM-IV-TR).
Mental retardation (IQ <70).
History of hypersensitivity to or intolerance of olanzapine or topiramate.
Prior history of olanzapine or topiramate non-response or allergic reaction.
DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.
Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline Children's Depression Rating Scale suicide score of >3).
Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.
Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.
Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified.

Sites / Locations

University of Cincinnati Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Topiramate Group

Placebo Group

Arm Description

Patients' initial dose of topiramate 25mg bid, which was titrated over 18 days to 150 mg bid (with flexibility to titrate to 200mg bid) as tolerated.

Sugar pill

Outcomes

Primary Outcome Measures

Change in Body Mass Index (BMI)

For all participants, BMI was computed using Change in BMI [kg/m2 (weight/height2)] over 12 weeks from Baseline to Week 12.

Change in Body Weight

For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.

Secondary Outcome Measures

Tolerability of Topiramate

To examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.

Full Information

NCT ID

NCT00394095

First Posted

October 27, 2006

Last Updated

April 3, 2013

Sponsor

University of Cincinnati

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00394095

Brief Title

Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine

Official Title

A Double-Blind, Randomized, Placebo-Controlled, Pilot Study of Topiramate vs. Placebo in Combination With Olanzapine for the Prevention of Weight Gain in Manic or Mixed Youth With Bipolar Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cincinnati

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder. The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.

Detailed Description

After consent and screening, patients will be initiated on 5mg or 10mg per day of olanzapine. Olanzapine doses will be titrated to 10-20 mg of olanzapine over one week, to a maximum of 20mg by day 21. Patients will also receive either topiramate (25mg bid titrated over 18 days to 150 mg bid. with flexibility to titrate to 200mg bid) or matched placebo. Topiramate will be initiated at a dose of 25 mg bid and will be increased by 25 mg bid every three days as tolerated. Patients will be evaluated by a blinded (to treatment status and adverse events) rater.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder, Weight Gain

Keywords

Bipolar Disorder, Weight Gain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Topiramate Group

Arm Type

Experimental

Arm Description

Patients' initial dose of topiramate 25mg bid, which was titrated over 18 days to 150 mg bid (with flexibility to titrate to 200mg bid) as tolerated.

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Sugar pill

Intervention Type

Drug

Intervention Name(s)

Topiramate

Other Intervention Name(s)

Topamax

Intervention Description

Oral topiramate 300-400mg/day for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar pill

Intervention Description

Matched placebo to Experimental arm

Primary Outcome Measure Information:

Title

Change in Body Mass Index (BMI)

Description

For all participants, BMI was computed using Change in BMI [kg/m2 (weight/height2)] over 12 weeks from Baseline to Week 12.

Time Frame

12 weeks

Title

Change in Body Weight

Description

For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Tolerability of Topiramate

Description

To examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients, ages 10-18 years. Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence). Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation. Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) bipolar disorder, type I and currently display an acute manic or mixed episode as determined by K-SADS (Geller et al 2000). Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16. Subjects should be fluent in English. Exclusion Criteria: Female patients who are either pregnant or lactating. Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions. Any history of current or past diabetes that has been treated with pharmacological intervention. Neurological disorders including epilepsy, stroke, or severe head trauma. Clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices. Clinically abnormal ECG. Manic or mixed episode due to a general medical condition or substance-induced mania (DSM-IV-TR). Mental retardation (IQ <70). History of hypersensitivity to or intolerance of olanzapine or topiramate. Prior history of olanzapine or topiramate non-response or allergic reaction. DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months. Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline Children's Depression Rating Scale suicide score of >3). Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0. Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants. Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV. Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melissa P DelBello, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cincinnati Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267-0559

Country

United States

12. IPD Sharing Statement

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Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine

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