Bipolar DisorderNCT00183495
Understanding Treatment Adherence Among Individuals With Bipolar Disorder
An observational study of Bipolar Disorder, run by Case Western Reserve University at 1 site in United States.
Trial summary
This study will examine how various factors, such as psychiatric symptoms, gender, social support, substance use, and attitudes toward medication, affect treatment adherence in individuals with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Aug 2007
- 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: Individuals with bipolar disorder receiving treatment at a Community Mental Health Clinic in Northeast Ohio.
Who may be able to join
- Clinical diagnosis of bipolar disorder type I for at least two years prior to study entry
- Has experienced an index depressive episode
- Received treatment with medication to stabilize mood for at least 6 months prior to study entry
- Able to participate in psychiatric interviews
- Lives in the Northeast Ohio area and is a patient at either Northeast Ohio Health Services or The Mood Disorders Clinic at University Hospitals of Cleveland
Who cannot join
- Unable/unwilling to participate in psychiatric interviews
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeast Ohio Health Services
Beachwood, Ohio, 44122
About this study
Official title: Determinants and Manifestation of Illness Behavior in Promoting Treatment Adherence Among Individuals With Bipolar Depression
This study will examine how various factors, such as psychiatric symptoms, gender, social support, substance use, and attitudes toward medication, affect treatment adherence in individuals with bipolar disorder.
Read the detailed description
Bipolar Disorder (BPD), also known as manic-depressive illness, is a disorder that causes frequent shifts in an individual's mood, energy, and ability to function. An individual with BPD may go through periods of mania, which are characterized by increased energy, irritability, and an excessively "high" euphoric mood. The manic periods are followed by periods of depression, which are characterized by decreased energy, feelings of hopelessness, and anxiety. BPD is a persistent and severe mental illness with a high suicide rate; it must be strictly managed through medication and therapy. Many BPD medications have been developed recently; however, there are still many individuals who do not respond well to medication treatment. Research has shown that the way individuals experience illness has an effect on their response to medication. The purpose of this study is to gain insight into how individuals with BPD perceive and respond to medication treatment. Factors such as gender, degree of social support, drug and alcohol usage, and attitudes towards medication will be evaluated to understand how they affect medication and treatment adherence.
This 6-month study will consist of 3 interviews. Each interview will last approximately 2 and ½ hours and will include numerous standardized psychological questionnaires. The questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; level of addiction to alcohol and drugs; availability of social support resources; and medication adherence.
- Conditions
- Bipolar Disorder
- Keywords
- Depression, Bipolar, Manic-Depressive Psychosis
- Medical subject headings
- Bipolar Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes toward Mood Stabilizers Questionnaire (AMSQ)
The AMSQ is a 19-item scale which is a modification of the Lithium Attitudes Questionnaire (LAQ) that evaluates an individual's attitude toward mood-stabilizing medication. The questions are in a yes/no format. The AMSQ has 7 subscales that represent key attitudinal domains with respect to adherence, as follows: 1. opposition to prophylaxis, 2. denial of therapeutic effectiveness, 3. fear of adverse effects, 4. difficulty with medication routines, 5. denial of illness severity, 6. negative attitude toward drugs in general, and 7. lack of information about mood stabilizers. Total scores range from 0 to 19. Higher scores on the total and each subscale represent more negative attitudes toward mood stabilizers.
Measured: Change from Baseline to 6 month visit
Brief Psychiatric Rating Scale (BPRS)
The BPRS measures levels of mania. There are 24 items, scored on a 7-point scale ranging from 0 to 6. Total scores range from 0 to 42, with higher scores indicating higher levels of mania.
Measured: Change from Baseline to 6 month visit
Addiction Severity Index (ASI)
A portion of the standardized instrument measuring level of addiction to alcohol and drugs. Items 1-14 of the Alcohol/Drug index were used. The ASI evaluated both lifetime and past-30 day use of a wide variety of commonly abused substances. Each question is divided by its maximum answer value and by the total number of questions in the composite. These individual results are then summed.
The six questions (A-F) that make up the alcohol composite score is determined by:
A/180 + B/180 + C/180 + D/24 + E/24 + log F/44.
The 13 questions (A-M) that make up the drug composite score is determined by:
A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 + H/390 + I/390 + J/390 + K/390 + L/52 + M/52.
Measured: Change from Baseline to 6 month visit
Interpersonal Suppose Evaluation List (ISEL)
The ISEL is a 40-item self-report questionnaire that was developed to assess availability of social support resources. A total index is composed of four subscales: tangible assistance (material aid), appraisal (availability of someone to talk to about life's problems), self-esteem (positive appraisal of self from others and positive comparison when comparing one's self with others) and belonging (people with whom one can do things). Response for each item is coded on a 4-point Likert scale ranging from definitely false to definitely true. Total scores range from 0 to 120, with higher scores indicating a higher availability of perceived social support.
Measured: Change from Baseline to 6 month visit
Tablets Routine Questionnaire (TRQ)
The TRQ evaluates adherence to medications via a brief self-report instrument that has been validated in populations with bipolar disorder medication adherence. The TRQ identifies nonadherent individuals, defined as those who miss 30% or more of their medication in the last week or month. Total scores are represented as a percentage and range from 0 to 100, with higher scores indicating a greater level of nonadherence (higher scores indicate worse adherence to medications).
Measured: Change from Baseline to 6 month visit
Hamilton Rating Scale for Depression (HAM-D)
The HAM-D measures form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Total scores range from 0-52, with higher scores indicating worse depression. The categories are as follows: 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score is 52.
Measured: Change from Baseline to 6 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionMar 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 140 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 School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183495
- Sponsor's protocol ID
- K23MH065599-01
- Other IDs
- K23MH065599-01, DAHBR 9K-TA
- Status last verified
- Jul 2019
- First submitted
- 13 Sep 2005
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Sajatovic M, Ignacio RV, West JA, Cassidy KA, Safavi R, Kilbourne AM, Blow FC. Predictors of nonadherence among individuals with bipolar disorder receiving treatment in a community mental health clinic. Compr Psychiatry. 2009 Mar-Apr;50(2):100-7. doi: 10.1016/j.comppsych.2008.06.008. Epub 2008 Aug 23.
PubMed 19216885Smilowitz S, Aftab A, Aebi M, Levin J, Tatsuoka C, Sajatovic M. Age-Related Differences in Medication Adherence, Symptoms, and Stigma in Poorly Adherent Adults With Bipolar Disorder. J Geriatr Psychiatry Neurol. 2020 Sep;33(5):250-255. doi: 10.1177/0891988719874116. Epub 2019 Sep 22.
PubMed 31542988Sajatovic M, Tatsuoka C, Cassidy KA, Klein PJ, Fuentes-Casiano E, Cage J, Aebi ME, Ramirez LF, Blixen C, Perzynski AT, Bauer MS, Safren SA, Levin JB. A 6-Month, Prospective, Randomized Controlled Trial of Customized Adherence Enhancement Versus Bipolar-Specific Educational Control in Poorly Adherent Individuals With Bipolar Disorder. J Clin Psychiatry. 2018 Sep 25;79(6):17m12036. doi: 10.4088/JCP.17m12036.
PubMed 30256551Sajatovic M, Micula-Gondek W, Tatsuoka C, Bialko C. The relationship of gender and gender identity to treatment adherence among individuals with bipolar disorder. Gend Med. 2011 Aug;8(4):261-8. doi: 10.1016/j.genm.2011.06.002. Epub 2011 Jul 16.
PubMed 21763217
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants and Manifestation of Illness Behavior in Promoting Treatment Adherence Among Individuals With Bipolar Depression
- ClinicalTrials.gov ID
- NCT00183495
- Acronym / sponsor ID
- K23MH065599-01
- Conditions
- Bipolar Disorder
- Keywords
- Depression, Bipolar, Manic-Depressive Psychosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 16 Sep 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.
This study will examine how various factors, such as psychiatric symptoms, gender, social support, substance use, and attitudes toward medication, affect treatment adherence in individuals with bipolar disorder.
Detailed description
Bipolar Disorder (BPD), also known as manic-depressive illness, is a disorder that causes frequent shifts in an individual's mood, energy, and ability to function. An individual with BPD may go through periods of mania, which are characterized by increased energy, irritability, and an excessively "high" euphoric mood. The manic periods are followed by periods of depression, which are characterized by decreased energy, feelings of hopelessness, and anxiety. BPD is a persistent and severe mental illness with a high suicide rate; it must be strictly managed through medication and therapy. Many BPD medications have been developed recently; however, there are still many individuals who do not respond well to medication treatment. Research has shown that the way individuals experience illness has an effect on their response to medication. The purpose of this study is to gain insight into how individuals with BPD perceive and respond to medication treatment. Factors such as gender, degree of social support, drug and alcohol usage, and attitudes towards medication will be evaluated to understand how they affect medication and treatment adherence.
This 6-month study will consist of 3 interviews. Each interview will last approximately 2 and ½ hours and will include numerous standardized psychological questionnaires. The questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; level of addiction to alcohol and drugs; availability of social support resources; and medication adherence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with bipolar disorder receiving treatment at a Community Mental Health Clinic in Northeast Ohio.
Key inclusion criteria (5 listed)
- Clinical diagnosis of bipolar disorder type I for at least two years prior to study entry
- Has experienced an index depressive episode
- Received treatment with medication to stabilize mood for at least 6 months prior to study entry
- Able to participate in psychiatric interviews
- Lives in the Northeast Ohio area and is a patient at either Northeast Ohio Health Services or The Mood Disorders Clinic at University Hospitals of Cleveland
Key exclusion criteria (1 listed)
- Unable/unwilling to participate in psychiatric interviews
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
Attitudes toward Mood Stabilizers Questionnaire (AMSQ)
Time frame: Change from Baseline to 6 month visit
The AMSQ is a 19-item scale which is a modification of the Lithium Attitudes Questionnaire (LAQ) that evaluates an individual's attitude toward mood-stabilizing medication. The questions are in a yes/no format. The AMSQ has 7 subscales that represent key attitudinal domains with respect to adherence, as follows: 1. opposition to prophylaxis, 2. denial of therapeutic effectiveness, 3. fear of adverse effects, 4. difficulty with medication routines, 5. denial of illness severity, 6. negative attitude toward drugs in general, and 7. lack of information about mood stabilizers. Total scores range from 0 to 19. Higher scores on the total and each subscale represent more negative attitudes toward mood stabilizers.
Brief Psychiatric Rating Scale (BPRS)
Time frame: Change from Baseline to 6 month visit
The BPRS measures levels of mania. There are 24 items, scored on a 7-point scale ranging from 0 to 6. Total scores range from 0 to 42, with higher scores indicating higher levels of mania.
Addiction Severity Index (ASI)
Time frame: Change from Baseline to 6 month visit
A portion of the standardized instrument measuring level of addiction to alcohol and drugs. Items 1-14 of the Alcohol/Drug index were used. The ASI evaluated both lifetime and past-30 day use of a wide variety of commonly abused substances. Each question is divided by its maximum answer value and by the total number of questions in the composite. These individual results are then summed. The six questions (A-F) that make up the alcohol composite score is determined by: A/180 + B/180 + C/180 + D/24 + E/24 + log F/44. The 13 questions (A-M) that make up the drug composite score is determined by: A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 + H/390 + I/390 + J/390 + K/390 + L/52 + M/52.
Interpersonal Suppose Evaluation List (ISEL)
Time frame: Change from Baseline to 6 month visit
The ISEL is a 40-item self-report questionnaire that was developed to assess availability of social support resources. A total index is composed of four subscales: tangible assistance (material aid), appraisal (availability of someone to talk to about life's problems), self-esteem (positive appraisal of self from others and positive comparison when comparing one's self with others) and belonging (people with whom one can do things). Response for each item is coded on a 4-point Likert scale ranging from definitely false to definitely true. Total scores range from 0 to 120, with higher scores indicating a higher availability of perceived social support.
Tablets Routine Questionnaire (TRQ)
Time frame: Change from Baseline to 6 month visit
The TRQ evaluates adherence to medications via a brief self-report instrument that has been validated in populations with bipolar disorder medication adherence. The TRQ identifies nonadherent individuals, defined as those who miss 30% or more of their medication in the last week or month. Total scores are represented as a percentage and range from 0 to 100, with higher scores indicating a greater level of nonadherence (higher scores indicate worse adherence to medications).
Hamilton Rating Scale for Depression (HAM-D)
Time frame: Change from Baseline to 6 month visit
The HAM-D measures form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Total scores range from 0-52, with higher scores indicating worse depression. The categories are as follows: 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score is 52.
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 31 Jul 2019.
- Results publication: PubMed 19216885Sajatovic M, Ignacio RV, West JA, Cassidy KA, Safavi R, Kilbourne AM, Blow FC. Predictors of nonadherence among individuals with bipolar disorder receiving treatment in a community mental health clinic. Compr Psychiatry. 2009 Mar-Apr;50(2):100-7. doi: 10.1016/j.comppsych.2008.06.008. Epub 2008 Aug 23.
- Derived from this study: PubMed 31542988Smilowitz S, Aftab A, Aebi M, Levin J, Tatsuoka C, Sajatovic M. Age-Related Differences in Medication Adherence, Symptoms, and Stigma in Poorly Adherent Adults With Bipolar Disorder. J Geriatr Psychiatry Neurol. 2020 Sep;33(5):250-255. doi: 10.1177/0891988719874116. Epub 2019 Sep 22.
- Derived from this study: PubMed 30256551Sajatovic M, Tatsuoka C, Cassidy KA, Klein PJ, Fuentes-Casiano E, Cage J, Aebi ME, Ramirez LF, Blixen C, Perzynski AT, Bauer MS, Safren SA, Levin JB. A 6-Month, Prospective, Randomized Controlled Trial of Customized Adherence Enhancement Versus Bipolar-Specific Educational Control in Poorly Adherent Individuals With Bipolar Disorder. J Clin Psychiatry. 2018 Sep 25;79(6):17m12036. doi: 10.4088/JCP.17m12036.
- Derived from this study: PubMed 21763217Sajatovic M, Micula-Gondek W, Tatsuoka C, Bialko C. The relationship of gender and gender identity to treatment adherence among individuals with bipolar disorder. Gend Med. 2011 Aug;8(4):261-8. doi: 10.1016/j.genm.2011.06.002. Epub 2011 Jul 16.
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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 School of Medicine
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 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 31 Jul 2019. 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?
Attitudes toward Mood Stabilizers Questionnaire (AMSQ) (time frame: Change from Baseline to 6 month visit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00183495, which also lists 4 linked publications.
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 31 Jul 2019.