NCT00264069

Brief Summary

The purpose of this study is to find out how well new treatment plans are followed by outpatients with major mental illnesses (schizophrenia, bipolar disorder, depression, personality disorder) and to determine the relationship between a diagnosis of schizophrenia and compliance with a treatment plan.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,622

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Shorter than P25 for all trials

Status
completed

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

June 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

December 9, 2005

Last Update Submit

May 18, 2011

Conditions

Keywords

AdherenceComplianceSchizophreniaBipolar DisorderDepressionPersonality DisordersRegistry

Outcome Measures

Primary Outcomes (1)

  • Comparison of compliance with different classes of drugs (such as antidepressants and antipsychotics), to determine whether a particular group of drugs is associated with improved compliance.

    3 months

Secondary Outcomes (1)

  • Comparison of compliance with different classes of drugs (such as antidepressants and antipsychotics), to determine whether a particular group of drugs is associated with improved compliance

    3 months

Study Arms (2)

001

Drug: antipsychotic

002

Drug: antidepressants

Interventions

as prescribed

001

as prescribed

002

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients diagnosed with schizophrenia, bipolar disorder or depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) classification characteristics who have been given a new therapy plan (that may include drug treatment for mental illness, visits to a mental health care worker, or other treatments such as non-medication type of treatments); patients either scheduled for treatment in the next 3 months or already treated for the past 3 months.

You may qualify if:

  • Outpatients diagnosed with schizophrenia, bipolar disorder or depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) classification characteristics who have been given a new therapy plan (that may include drug treatment for mental illness, visits to a mental health care worker, or other treatments such as non-medication type of treatments)
  • Patients either scheduled for treatment in the next 3 months or already treated for the past 3 months

You may not qualify if:

  • Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder/ bipolar disease/major depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

SchizophreniaBipolar DisorderDepressionPersonality DisordersPatient Compliance

Interventions

Antipsychotic AgentsAntidepressive Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersBehavioral SymptomsBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Tranquilizing AgentsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesPsychotropic Drugs

Study Officials

  • Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

    Janssen-Cilag, S.A.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

June 1, 2005

Study Completion

June 1, 2006

Last Updated

May 19, 2011

Record last verified: 2010-04