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

This study has been completed.
Sponsor:
Information provided by:
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT00264069
First received: December 9, 2005
Last updated: May 18, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention
Schizophrenia
Bipolar Disorder
Depression
Personality Disorder
Drug: antipsychotic
Drug: antidepressants

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study ADH.E.R.E.: "Therapeutic ADHerence and Treatment Strategies: Mental Health Registry"

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag, S.A.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2622
Study Start Date: June 2005
Study Completion Date: June 2006
Groups/Cohorts Assigned Interventions
001 Drug: antipsychotic
as prescribed
002 Drug: antidepressants
as prescribed

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  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: NCT00264069

Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
  More Information

Additional Information:
No publications provided

Responsible Party: Country Medical Director, Janssen-Cilag S.A., Spain
ClinicalTrials.gov Identifier: NCT00264069     History of Changes
Other Study ID Numbers: CR005755
Study First Received: December 9, 2005
Last Updated: May 18, 2011
Health Authority: Spain: Spanish Drug Agency

Keywords provided by Janssen-Cilag, S.A.:
Adherence
Compliance
Schizophrenia
Bipolar Disorder
Depression
Personality Disorders
Registry

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Personality Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Antidepressive Agents
Antipsychotic Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2014