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Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine

University Hospitals (UH) logo

University Hospitals (UH)

Status and phase

Terminated
Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: Olanzapine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00194064
F1DMC-X136

Details and patient eligibility

About

Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days in the hospital to observe response to medication. Patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli Lilly and Company.

Enrollment

18 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The subject satisfied Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of Bipolar Disorder, most recently manic
  • The patient is willing to be hospitalized on an inpatient psychiatric unit for a minimum of seven (7) days.
  • Subject has been treated with lithium in the past.
  • Subject has been treated with divalproex or carbamazepine in the past.
  • Subject has been treated with Haldol or haloperidol in the past.

Exclusion criteria

  • Subjects lacks the capacity to provide informed consent
  • Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators
  • Subject has been dependent on a drug (other than nicotine or caffeine) in the last three (3) months.

Trial design

18 participants in 1 patient group

Olanzapine
Experimental group
Description:
Subjects were be started on a standardized minimum first-day dose of 15 mg olanzapine. After the first day of therapy, the daily dose was either increased or decreased, as clinically indicated, by 5 mg, within an allowed range of 5 to 40 mg
Treatment:
Drug: Olanzapine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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