NCT00287027

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 5, 2007

Status Verified

January 1, 2007

First QC Date

February 2, 2006

Last Update Submit

January 4, 2007

Conditions

Psychotic Disorders

Keywords

psychotic disordersfamily burdenlong acting injectible antipsychotic medication

Interventions

Risperdal Long Acting Injectable Antipsychotic MedicationDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NAMI NH

Concord, New Hampshire, 03301, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Alex deNesnera, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2006

First Posted

February 6, 2006

Study Start

February 1, 2006

Study Completion

December 1, 2006

Last Updated

January 5, 2007

Record last verified: 2007-01

Locations

US(1)