Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)

Lilly

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Treatments: Drug: Sublingual orally disintegrating olanzapine (SODO); Drug: Oral olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00303602

10268

F1D-CA-S063

Details and patient eligibility

About

This study is testing if under the tongue olanzapine for schizophrenia, related psychosis, schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that is swallowed, in patients who are already gaining weight on olanzapine.

Enrollment: 149 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Patients must):

• Be at least 18 years old
• Have gained weight while taking olanzapine
• Be able to visit the doctor's office seven times over 4 months (17 weeks)

Exclusion Criteria (Patients must NOT):

• Have started a weight loss program within the last 8 weeks
• Have an illness that might affect patient's weight during the study
• Have an allergy to phenylalanine, mannitol or saccharine
• Be taking any medication (except for olanzapine) that might affect patient's weight

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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149 participants in 2 patient groups

A

Experimental group

Description:

Sublingual orally disintegrating olanzapine (SODO)

Treatment:

Drug: Sublingual orally disintegrating olanzapine (SODO)

B

Active Comparator group

Description:

Oral olanzapine

Treatment:

Drug: Oral olanzapine