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

This study has been terminated.
Sponsor:
Collaborator:
Janssen Medical Affairs
Information provided by:
National Alliance on Mental Illness New Hampshire
ClinicalTrials.gov Identifier:
NCT00287027
First received: February 2, 2006
Last updated: January 4, 2007
Last verified: January 2007
  Purpose

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.


Condition Intervention
Psychotic Disorders
Drug: Risperdal Long Acting Injectable Antipsychotic Medication

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Family Perspectives:Treatment of Psychiatric Illnesses With Atypical Long Acting Injectable Antipsychotic Medication

Resource links provided by NLM:


Further study details as provided by National Alliance on Mental Illness New Hampshire:

Estimated Enrollment: 60
Study Start Date: February 2006
Estimated Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287027

Locations
United States, New Hampshire
NAMI NH
Concord, New Hampshire, United States, 03301
Sponsors and Collaborators
National Alliance on Mental Illness New Hampshire
Janssen Medical Affairs
Investigators
Principal Investigator: Alex deNesnera, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00287027     History of Changes
Other Study ID Numbers: CPHS#17558
Study First Received: February 2, 2006
Last Updated: January 4, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by National Alliance on Mental Illness New Hampshire:
psychotic disorders
family burden
long acting injectible antipsychotic medication

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014