ADH.E.R.E.: Therapeutic ADHerence and Treatment Strategies: A Mental Health Registry

May 18, 2011 updated by: Janssen-Cilag, S.A.

Study ADH.E.R.E.: "Therapeutic ADHerence and Treatment Strategies: Mental Health Registry"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Compliance (which refers to how well one follows a prescribed medication or therapy) varies among all types of diseases, but it is generally low for those outpatients with major mental illness. This leads to relapses and worsening of their condition, and worsening of their condition may lead to poor compliance. The purpose of the study is to record, analyze, and report how well patients with major mental illness in an outpatient setting follow the prescribed treatment plan for the first few months of a new treatment strategy (either a first-time therapy plan or a change to a therapy plan). Therapy plans include psychiatric counseling (psychotherapy), visits to the outpatient clinic, and taking prescribed drugs. "Compliance" is defined as actually doing what the plan says, including attending therapy sessions, going for clinic visits, and taking necessary medication. The study will look for individual factors for each patient that might influence lack of compliance, and then see whether some of the individual factors predict a lack of compliance in the group as a whole, which includes approximately 2500 patients. These factors include a diagnosis of schizophrenia compared with a diagnosis of another major mental illness such as depression, bipolar disorder, or personality disorder. Social and personal factors will also be recorded and analyzed to see whether they influence the patient's ability to follow the treatment plan. Examples are age, sex, education, race, urban versus rural lifestyle, family supportiveness, and substance abuse status. Other factors to be studied that may vary between patients who are either good, average, or poor at following their treatment plan include the number of hospital admissions for each patient, how long it has been since their last hospitalization, and the reason why their new therapy plan was changed or started. The study will also try to determine how physicians confirm the patient's reports of their adherence to their treatment plan. A physician may take blood to measure levels of the drug, count a patient's pills or injections, or simply ask the patient or a family member. Researchers will compare compliance when different classes of drugs are prescribed, such as antidepressants and antipsychotics, to determine whether a particular group of drugs is associated with improved compliance. The safety and effectiveness of the drugs prescribed might also influence whether patients take their medication, so these factors will be evaluated. Adverse events (unintended and undesirable effects that might be due to the treatments) will be recorded for each patient over the 3 months of the study, and the physician will record the results of a Global Clinical Impression scale that ranges from "No Illness" to "Extreme Illness" to record an overall impression of the patient's illness before and after treatment. Antipsychotics and antidepressants, as used in routine clinical practice. Study duration is 3 months.

Study Type

Observational

Enrollment (Actual)

2622

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
Drug: antipsychotic
as prescribed
002
Drug: antidepressants
as prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag, S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

June 1, 2005

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

December 9, 2005

First Submitted That Met QC Criteria

December 9, 2005

First Posted (Estimate)

December 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005755

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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