Status:
TERMINATED
Decision Aid to Facilitate Shared Decision Making During Treatment in Schizophrenia
Lead Sponsor:
VA Nebraska Western Iowa Health Care System
Collaborating Sponsors:
US Department of Veterans Affairs
Nebraska Educational Biomedical Research Association
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
FEMALE
19-65 years
Phase:
NA
Brief Summary
We hypothesize that the use of a visual decision aid tool to educate patients regarding potential harm with respect to weight gain with olanzapine versus perphenazine can lead to better shared decisio...
Eligibility Criteria
Inclusion
- Patients with diagnosis of Schizophrenia or Schizoaffective Disorder as per by their medical record diagnosis.
- Patients currently on olanzapine therapy and BMI \>29.9.
- Patients treated with olanzapine for greater than or equal to 3 months prior to enrollment.
- Patient would be required to have either attempted dietary, lifestyles modifications and/or participated in weight loss programs.
- Patients with no history of psychiatric hospitalizations in past six months and judged by treating clinician to be suitable for antipsychotic medication switch.
- Patients with adequate decisional capacity to make a choice about participating in this research study.
- Patients, who are able to comprehend and satisfactorily comply with protocol requirements and have an ability to read and write English.
- Patients, who signed the written consent given prior to entering any study procedure.
Exclusion
- Patients with a history of treatment resistant schizophrenia or past trials with clozapine.
- Patients with a concurrent DSM-IV diagnosis of PTSD as per their medical record.
- Substance Dependence or Abuse (excluding nicotine) within one month prior to the screening visit.
- Patients with a history of non-response, intolerance or hypersensitivity ot perphenazine.
- Subjects with history of treatment of clozapine.
- Patients who based on history of mental status examination have a significant risk of committing suicide.
- Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
- Female patients who are pregnant, planning to become pregnant, or if of childbearing potential, not using an acceptable method of birth control.
- Patient currently receiving depot neuroleptics.
- Patients with visual impairments.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01420575
Start Date
October 1 2010
End Date
August 1 2012
Last Update
September 19 2012
Active Locations (1)
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1
Omaha Veterans Affairs Medical Center
Omaha, Nebraska, United States, 68105