Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine
Condition: Bipolar Disorder; Weight Gain
MeSH terms: Body Weight; Weight Gain; Bipolar Disorder
Intervention: Topiramate; Placebo
Intervention description: Oral topiramate 300-400mg/day for 12 weeks; Matched placebo to Experimental arm
Intervention MeSH terms: Topiramate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Weight Gain

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients, ages 10-18 years.

          2. Female patients of menarche must be using a medically accepted means of contraception
             (e.g. oral contraceptives, Depo-Provera, abstinence).

          3. 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.

          4. 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).

          5. Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16.

          6. Subjects should be fluent in English.

        Exclusion Criteria:

          1. Female patients who are either pregnant or lactating.

          2. Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory,
             cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical
             conditions.

          3. Any history of current or past diabetes that has been treated with pharmacological
             intervention.

          4. Neurological disorders including epilepsy, stroke, or severe head trauma.

          5. 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.

          6. Manic or mixed episode due to a general medical condition or substance-induced mania
             (DSM-IV-TR).

          7. Mental retardation (IQ <70).

          8. History of hypersensitivity to or intolerance of olanzapine or topiramate.

          9. Prior history of olanzapine or topiramate non-response or allergic reaction.

         10. DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.

         11. 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).

         12. Treatment with an injectable depot neuroleptic within less than one dosing interval
             between depot neuroleptic injections and day 0.

         13. Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except
             as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.

         14. 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.

         15. Major depressive disorder, dysthymic disorder, depressive disorder not otherwise
             specified.