- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00287027
Family Perspectives:Treatment of Psychiatric Illnesses With Atypical Long Acting Injectable Antipsychotic Medication
January 4, 2007 updated by: National Alliance on Mental Illness New Hampshire
Patients who have schizophrenia, schizoaffective disorder, a psychotic disorder, and are being treated with a medication called Risperidone Long Acting Injectable medication or another antipsychotic medication are candidates for the study.
The purpose of the study is to find out from patients' family how they feel the medication has affected their relationship with them.
The study will involve meeting with family members three times over the course of one year.
The first time will be at New Hampshire Hospital (NHH) or at a community mental health center and the follow up times will be at a convenient place and time for the family member (s), in the community.
We will ask them to answer questions from the Family Burden Interview and Quality of Life Questionnaire.
The family will not be charged for any test that is completed solely for this study.
The family will be provided a travel stipend to meet with the researchers.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Patients who have schizophrenia, schizoaffective disorder, a psychotic disorder, and are being treated with a medication called Risperidone Long Acting Injectable medication or another antipsychotic medication are candidates for the study.
The purpose of the study is to find out from patients' family how they feel the medication has affected their relationship with them.The study will involve meeting with family members three times over the course of one year.
The first time will be at New Hampshire Hospital (NHH) or at a community mental health center and the follow up times will be at a convenient place and time for the family member (s), in the community.
We will ask them to answer questions from the Family Burden Interview and Quality of Life Questionnaire.
The family will not be charged for any test that is completed solely for this study.
The family will be provided a travel stipend to meet with the researchers.We do not see that there will be any risks to the family.
We will be interviewing the patient's family, and they will be sharing information as to how they feel their relationship with the patient is going.
All efforts will be made to keep this information confidential; however, there may be unforeseen circumstances that could lead to breaching of confidentiality.
If the family expresses need for help the research staff will make recommendations for referral to a provider.
Study Type
Observational
Enrollment
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Hampshire
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Concord, New Hampshire, United States, 03301
- NAMI NH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Inclusion criteria:Families of adults between the ages of 18-65 who have a diagnosis of Schizophrenia, Schizoaffective Disorder, Psychotic Disorder NOS, and whose loved one gave permission for them to be contacted.
- Either a) a family member whose adult consumer started on Risperidone Long Acting Injection within one month, while at New Hampshire Hospital and/or at a Community Mental Health Center and who consented to participate; or b) a family member whose adult consumer was switched from one antipsychotic medication to another (excluding clozapine) within one month, while at New Hampshire Hospital and/or at a Community Mental Health Center and who consented to participate.
- Families that have at least 4 hours per week contact with their loved one with mental illness for 2 of the 4 weeks preceding the medication change.
Exclusion Criteria:
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alex deNesnera, MD, Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
February 2, 2006
First Submitted That Met QC Criteria
February 2, 2006
First Posted (Estimate)
February 6, 2006
Study Record Updates
Last Update Posted (Estimate)
January 5, 2007
Last Update Submitted That Met QC Criteria
January 4, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPHS#17558
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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