Family Perspectives:Treatment of Psychiatric Illnesses With Atypical Long Acting Injectable Antipsychotic Medication

NCT ID: NCT00287027

Last Updated: 2007-01-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2006-12-31

Brief Summary

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.

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.

Conditions

Psychotic Disorders

Study Design

• Observational Model Type: DEFINED_POPULATION
• Study Time Perspective: PROSPECTIVE

Interventions

Risperdal Long Acting Injectable Antipsychotic Medication

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Medical Affairs

INDUSTRY

Sponsor Role: collaborator

National Alliance on Mental Illness New Hampshire

OTHER

Sponsor Role: lead

Principal Investigators

Alex deNesnera, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

NAMI NH

Concord, New Hampshire, United States

Countries

United States

Other Identifiers

CPHS#17558

Identifier Type: -

Identifier Source: org_study_id