SchizophreniaNCT00264069
ADH.E.R.E.: Therapeutic ADHerence and Treatment Strategies: A Mental Health Registry
An observational study of Schizophrenia and Bipolar Disorder, run by Janssen-Cilag, S.A..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Depression
- What is being tested?
- antipsychotic and antidepressants
- How many people
- 2,622 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder/ bipolar disease/major depression
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia, Bipolar Disorder, Depression, Personality Disorder
- Being tested
- antipsychotic, antidepressants
- Keywords
- Adherence, Compliance, Schizophrenia, Bipolar Disorder, Depression, Personality Disorders, Registry
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depression, Personality Disorders, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antipsychoticDrug
as prescribed
antidepressantsDrug
as prescribed
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Drug: antipsychotic | |
| 002 | Not described Receives: Drug: antidepressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startJun 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial, Study director, Janssen-Cilag, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264069
- Sponsor's protocol ID
- CR005755
- Status last verified
- Apr 2010
- First submitted
- 9 Dec 2005
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study ADH.E.R.E.: "Therapeutic ADHerence and Treatment Strategies: Mental Health Registry"
- ClinicalTrials.gov ID
- NCT00264069
- Acronym / sponsor ID
- CR005755
- Conditions
- Schizophrenia, Bipolar Disorder, Depression, Personality Disorder
- Keywords
- Adherence, Compliance, Schizophrenia, Bipolar Disorder, Depression, Personality Disorders, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,622 participants (actual)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 12 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: antipsychotic |
| 002 | – | Drug: antidepressants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder/ bipolar disease/major depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antipsychoticas prescribed | Drug | 001 |
| antidepressantsas prescribed | Drug | 002 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Treatment Adherence and Strategies: A Mental Illness Registry (ADHERE study)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial study director
Janssen-Cilag, S.A.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar Disorder, run by Janssen-Cilag, S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.