A Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain

NCT00363376 | Completed Phase 3

• 2 other identifiers: 06-06-14-01F1D-MC-X269
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Gain

Keywords

olanzapine; zonisamide; weight gain; bipolar disorder; psychotic disorders

Outcome Measures

Primary Outcomes (1)

• change in weight from baseline to endpoint

  16 weeks

Secondary Outcomes (7)

• changes, from baseline to endpoint, in BMI

  16 weeks

• changes, from baseline to endpoint, in abdominal circumference

  16 weeks

• changes, from baseline to endpoint, in metabolic parameters

  16 weeks

• changes, from baseline to endpoint, in clinical global improvement of psychiatric symptoms

  16 weeks

• changes, from baseline to endpoint, in manic symptoms

  16 weeks

Study Arms (2)

Sugar pill

EXPERIMENTAL

olanzapine and placebo ("sugar pill")

Drug: zonisamide; Drug: olanzapine; Drug: Sugar Pill (placebo)

Zonisamide

EXPERIMENTAL

olanzapine and zonisamide (active drug)

Drug: zonisamide; Drug: olanzapine

Interventions

Zonisamide DRUG

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).

Also known as: Zonegran

Sugar pill; Zonisamide

olanzapine DRUG

olanzapine will be administered open-label at 5-20 mg/d titrated to optimize response and minimize side effects

Also known as: Zyprexa, Zydis

Sugar pill; Zonisamide

Sugar Pill (placebo) DRUG

sugar pill (placebo) for zonisamide

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• Eli Lilly and Company: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

The Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

Related Publications (1)

• 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.

  PMID: 22367654 RESULT

MeSH Terms

Conditions

Weight Gain; Bipolar Disorder; Psychotic Disorders

Interventions

Zonisamide; Olanzapine; Sugars

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Study Officials

• Susan McElroy, MD

  The Lindner Center of HOPE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 15, 2006
• Study Start: January 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 13, 2012

Record last verified: 2012-04

Locations

US (1)