Bipolar DisorderNCT00763581
Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients
An observational study of Bipolar Disorder, run by Case Western Reserve University at 1 site in United States.
Trial summary
This study will attempt to increase understanding of why bipolar disorder patients do or do not take their medications by conducting in-depth interviews with them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jan 2009
- 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: Twenty adults (10 men and 10 women) receiving standard outpatient mental health treatment at Connections, a community mental health clinic (CMHC).
Who may be able to join
- Clinical diagnosis of bipolar disorder (BPD) Type I or Type II, as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
- Demonstrated history of poor medication adherence, as determined by self-report or clinician report. In this study, self-reported treatment nonadherence will be identified with the Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 30% or more of medication within either the past week or past month (those missing 30% or more within past week will be considered to be non-adherent over the past month). Clinician-assessed nonadherence will be identified via a clinician version of the TRQ to identify nonadherence of 30% or more over the past 30 days.
- BPD of at least 2 years' duration
- Treatment with medication to stabilize mood for at least 6 months
- A Clinical Global Impression (CGI-BP) overall bipolar illness score of 4 or higher
Who cannot join
- Unable or unwilling to participate in psychiatric interviews, as based on the clinical opinion of the investigator or the treating clinician
- High risk of suicide, as seen in factors such as active suicidal ideation, recent suicide attempt, or current suicidal intent or plan
- Inability to speak English
- Receiving treatment involuntarily
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)
This study will attempt to increase understanding of why bipolar disorder patients do or do not take their medications by conducting in-depth interviews with them.
Read the detailed description
Disruptive manic and depressive episodes prevent bipolar disorder (BPD) sufferers from living healthy, functional lives. Relapse rates for BPD are high, between 70% and 90%, with approximately half of those relapses occurring in the first 2 years after remission. High rates of relapse and no substantial improvements in illness outcomes for many patients despite advances in drug treatment may be related to a common problem: medication nonadherence. Nine in 10 individuals with BPD have seriously considered medication withdrawal, and one third of individuals with BDP do not take 30% or more of their prescribed medications. The researchers in this study will identify BPD patients who do not take their medications as prescribed and conduct interviews with them. By obtaining an understanding of subjective reasons for medication nonadherence, this study will pave the way for better interventions to ensure BDP patients take the medications that will help them.
Participation in this study will consist of a single visit, lasting between 1.5 and 3 hours. All participants will have a history of medication nonadherence. Participants will be asked to fill out questionnaires and undergo a structured interview with a researcher. The interview will be audio recorded. The questionnaires and interview will assess BPD symptoms, attitudes toward medications, and to what extent patients are taking their medications. Researchers will also measure the number of pills used in participants' prescriptions by counting how many pills are left in each prescription bottle.
- Conditions
- Bipolar Disorder
- Keywords
- Patient Non-Adherence, Patient Non-Compliance, Patient Nonadherence, Patient Noncompliance, Patient Refusal of Treatment, Treatment Refusal, Refusal of Treatment
- Medical subject headings
- Bipolar Disorder, Patient Compliance, Treatment Refusal
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Experience of Medication Interview (SEMI) TAD BD, a qualitative instrument modified from the original SEMI
Measured: An average of 4 hours
Secondary outcomes (4)
Hamilton Rating Scale for Depression (HAM-D)
Measured: An average of 4 hours
Young Mania Rating Scale (YMRS)
Measured: An average of 4 hours
Brief Psychiatric Rating Scale (BPRS)
Measured: An average of 4 hours
Clinical Global Impression for Bipolar Disorder (CGI-BP)
Measured: An average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Martha Sajatovic, MD, Case Western Reserve University
- Investigators
- Martha Sajatovic, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763581
- Sponsor's protocol ID
- R34MH078967-01
- Other IDs
- R34MH078967-01, R34MH078967, DAHBR 96-BHA
- Status last verified
- Jan 2017
- First submitted
- 19 Sep 2008
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)
- ClinicalTrials.gov ID
- NCT00763581
- Acronym / sponsor ID
- R34MH078967-01
- Conditions
- Bipolar Disorder
- Keywords
- Patient Non-Adherence, Patient Non-Compliance, Patient Nonadherence, Patient Noncompliance, Patient Refusal of Treatment, Treatment Refusal, Refusal of Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Oct 2008 (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.
This study will attempt to increase understanding of why bipolar disorder patients do or do not take their medications by conducting in-depth interviews with them.
Detailed description
Disruptive manic and depressive episodes prevent bipolar disorder (BPD) sufferers from living healthy, functional lives. Relapse rates for BPD are high, between 70% and 90%, with approximately half of those relapses occurring in the first 2 years after remission. High rates of relapse and no substantial improvements in illness outcomes for many patients despite advances in drug treatment may be related to a common problem: medication nonadherence. Nine in 10 individuals with BPD have seriously considered medication withdrawal, and one third of individuals with BDP do not take 30% or more of their prescribed medications. The researchers in this study will identify BPD patients who do not take their medications as prescribed and conduct interviews with them. By obtaining an understanding of subjective reasons for medication nonadherence, this study will pave the way for better interventions to ensure BDP patients take the medications that will help them.
Participation in this study will consist of a single visit, lasting between 1.5 and 3 hours. All participants will have a history of medication nonadherence. Participants will be asked to fill out questionnaires and undergo a structured interview with a researcher. The interview will be audio recorded. The questionnaires and interview will assess BPD symptoms, attitudes toward medications, and to what extent patients are taking their medications. Researchers will also measure the number of pills used in participants' prescriptions by counting how many pills are left in each prescription bottle.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty adults (10 men and 10 women) receiving standard outpatient mental health treatment at Connections, a community mental health clinic (CMHC).
Key inclusion criteria (5 listed)
- Clinical diagnosis of bipolar disorder (BPD) Type I or Type II, as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
- Demonstrated history of poor medication adherence, as determined by self-report or clinician report. In this study, self-reported treatment nonadherence will be identified with the Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 30% or more of medication within either the past week or past month (those missing 30% or more within past week will be considered to be non-adherent over the past month). Clinician-assessed nonadherence will be identified via a clinician version of the TRQ to identify nonadherence of 30% or more over the past 30 days.
- BPD of at least 2 years' duration
- Treatment with medication to stabilize mood for at least 6 months
- A Clinical Global Impression (CGI-BP) overall bipolar illness score of 4 or higher
Key exclusion criteria (4 listed)
- Unable or unwilling to participate in psychiatric interviews, as based on the clinical opinion of the investigator or the treating clinician
- High risk of suicide, as seen in factors such as active suicidal ideation, recent suicide attempt, or current suicidal intent or plan
- Inability to speak English
- Receiving treatment involuntarily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective Experience of Medication Interview (SEMI) TAD BD, a qualitative instrument modified from the original SEMI
Time frame: An average of 4 hours
4 secondary outcomes
Hamilton Rating Scale for Depression (HAM-D)
Time frame: An average of 4 hours
Young Mania Rating Scale (YMRS)
Time frame: An average of 4 hours
Brief Psychiatric Rating Scale (BPRS)
Time frame: An average of 4 hours
Clinical Global Impression for Bipolar Disorder (CGI-BP)
Time frame: An average of 4 hours
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 1 Feb 2017.
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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.
Martha Sajatovic, MD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Case Western Reserve University at 1 site in United States.
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 5 inclusion and 4 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Subjective Experience of Medication Interview (SEMI) TAD BD, a qualitative instrument modified from the original SEMI (time frame: An average of 4 hours). 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 1 Feb 2017.