Status:
COMPLETED
Study of Amantadine for Weight Stabilization During Olanzapine Treatment
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Psychotic Disorder
Schizophreniform Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Weight gain associated with antipsychotic medication use is a major side effect that limits the tolerability of these drugs. This often significant weight gain adversely affects health, increasing ris...
Detailed Description
Screening: Screening will include demographics, medical and psychiatric histories and a clinical interview to determine psychiatric diagnosis. Screening will also include a physical examination and la...
Eligibility Criteria
Inclusion
- Ages 18-65
- Male and female
- DSM IV diagnosis of psychotic episode (brief psychotic disorder, schizophreniform disorder, schizophrenia, schizoaffective disorder)or mood disorder with psychotic features
- Subjects may have lifetime exposure to antipsychotic medications other than olanzapine of up to 8 weeks
- Olanzapine monotherapy is appropriate treatment as judged by their treating physician.
- Less than 12 weeks of olanzapine monotherapy treatment at entrance into phase 1.
- Able to consent
- Female subjects require medically acceptable means of birth control which includes tubal ligation, hysterectomy, condoms, oral contraceptives, IUD, cervical cap, diaphragm, transdermal contraceptive patch, and abstinence.
Exclusion
- Current treatment with lithium, depakote, carbamazepine, lamotrigine, mirtazapine, corticosteroids, or stimulants (methamphetamine, etc).
- Known sensitivity or contraindication to amantadine
- Suicidal or homicidal risk
- Pregnant, desiring to become pregnant during the study period, or lactating
- Serious or unstable medical illness that require ongoing treatment with medication
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00287352
Start Date
May 1 2005
End Date
September 1 2009
Last Update
May 2 2011
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599