Bipolar DisorderNCT00183703
Understanding Treatment Adherence Among Individuals With Rapid Cycling Bipolar Disorder
An observational study of Bipolar Disorder, run by Case Western Reserve University at 2 sites in United States.
Trial summary
This study will examine how various factors, such as psychiatric symptoms, gender, quality of life, and attitudes toward medication, affect treatment adherence in individuals with rapid cycling 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
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 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: The population includes 20 individuals receiving treatment at an academic medical center and 20 individuals seeking treatment at a community mental health clinic.
Who may be able to join
- Clinical diagnosis of rapid cycling variant of bipolar disorder type I; diagnosed 2 to 20 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
- 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
2 sites in 1 country.
United States2 sites
Northeast Ohio Health Services
Beachwood, Ohio, 44122
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Official title: Rapid Cycling Bipolar Disorder (RCBPD), Subjective Illness Experience and Gender
This study will examine how various factors, such as psychiatric symptoms, gender, quality of life, and attitudes toward medication, affect treatment adherence in individuals with rapid cycling 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. Rapid cycling bipolar disorder (RCBPD) is a type of BPD in which the individual experiences four or more episodes of mania and depression per year. The rapid shift between the manic and depressive episodes makes it imperative that individuals with RCBPD strictly manage their illness with medication. 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 RCBPD 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 study will consist of 1 visit, which will last approximately 2 and ½ hours and will include an anthropological interview and numerous standardized psychological questionnaires. The interview and questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; expectations regarding recovery, stigma, and quality of life; and medication adherence.
- Conditions
- Bipolar Disorder
- Keywords
- Depression, Bipolar, Manic-Depressive Psychosis
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Qualitative Interview | Participants with rapid cycling bipolar disorder (RCBPD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Subjective Experience of Medication Interview (SEMI)
The Subjective Experience of Medication Interview (SEMI) is a qualitative, semi-structured assessment of subjective experience of mental illness, which requires approximately 60-120 minutes to administer. Illness experience domains assessed include illness attitudes, attributions and behaviors, social relations, treatment history and medication experience, self-medication, quality of life, stigma, culture/ethnicity, and health care logistics. The SEMI has been modified for use in populations with Bipolar Disorder.
Measured: Baseline
Secondary outcomes (7)
Hamilton Depression Rating Scale (HAMD)
A rater administered rating to scale to measure symptoms of depression, and is the most commonly utilized rating scale to assess depressive symptoms in bipolar depression clinical studies.
Measured: Baseline
Clinical Global Impression (CGI)
Global illness severity is measured with the Clinical Global Impressions (CGI), a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.66-0.41.
Measured: Baseline
Insight and Treatment Attitudes Questionnaire (ITAQ)
An 11-item rating scale to evaluate patient recognition of illness and need for treatment in psychiatric illness. Each ITAQ item is scored on a 0 to 2 scale (0 = no insight, 2 = good insight), and the scale has high interrater reliability (r=0.82, p<.001) (McEvoy 1981). Construct validity, checked by correlating scores with an open interview is also good (r=.85, p<.001).
Measured: Baseline
Illness Behavior Questionnaire (IBQ)
A 62-item instrument designed to measure a respondent's attitudes, ideas, affects and attributions in relation to illness. The IBQ is a self-reported scale, in which the respondent answers "yes" or "no" to each question regarding illness experience and subjective response. There are seven major subscales derived through factor analysis. The IBQ has very good stability, with one-to-twelve week test-retest correlations ranging from .67-.85 for the subscales. It has good face and content validity.
Measured: Baseline
Attitude Towards Mood Stabilizers Questionnaire (AMSQ)
A modification of the Lithium Attitudes Questionnaire (Harvey 1991) which evaluates an individual's attitudes towards mood stabilizing medication (Adams and Scott 2000). The AMSQ comprises 19 items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information about mood stabilizers (1 item). Higher scores on each subscale represent more negative attitudes toward mood stabilizers. Reliability for the 19 items ranges from 57.6 % to 96.9%.
Measured: Baseline
Multidimensional Health Locus of Control Scale (MHLC)
An 18-item instrument that measures three dimensions of locus of control of reinforcement as it pertains to health (internal, IHLC: external-chance, CHLC: and external powerful others, PHLC). Scoring is from 6-36 with higher scores indicating stronger beliefs. The internal consistency reliability using Cronbach's alpha ranges from .67 to .77 for the three dimensions, and the measure has fairly good criterion validity (Wallston 1978).
Measured: Baseline
Treatment Adherence
Treatment adherence will be evaluated in the following three ways: 1) The primary measure will be the Tablet Routines Questionnaire (TRQ, Peet 1991) which is a validated assessment of adherence among individuals with bipolar disorders (Scott 2002, Peet 1991), 2) Blood level of mood stabilizing and antipsychotic medications will be identified from the patient record. This has been identified as a standard of care in numerous guidelines for the treatment of bipolar disorder (American Psychiatric Association 2000, Goldberg 2000). 3) Adherence with clinic visits for the previous three month time period will be calculated as a percentage.
Measured: Baseline
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 startJul 2004
- Primary completionNov 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cross-sectional
- Enrolment
- 40 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
- NCT00183703
- Sponsor's protocol ID
- K23MH065599-02
- Other IDs
- K23MH065599-02
- Status last verified
- Feb 2019
- First submitted
- 14 Sep 2005
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Sajatovic M, Jenkins JH, Cassidy KA, Muzina DJ. Medication treatment perceptions, concerns and expectations among depressed individuals with Type I Bipolar Disorder. J Affect Disord. 2009 Jun;115(3):360-6. doi: 10.1016/j.jad.2008.10.002. Epub 2008 Nov 8.
PubMed 18996600Sajatovic M, Jenkins JH, Safavi R, West JA, Cassidy KA, Meyer WJ, Calabrese JR. Personal and societal construction of illness among individuals with rapid-cycling bipolar disorder: a life-trajectory perspective. Am J Geriatr Psychiatry. 2008 Sep;16(9):718-26. doi: 10.1097/JGP.0b013e3180488346. Epub 2007 Dec 10.
PubMed 18070834
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Cycling Bipolar Disorder (RCBPD), Subjective Illness Experience and Gender
- ClinicalTrials.gov ID
- NCT00183703
- Acronym / sponsor ID
- K23MH065599-02
- Conditions
- Bipolar Disorder
- Keywords
- Depression, Bipolar, Manic-Depressive Psychosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2004
- Primary completion
- Nov 2006 (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, quality of life, and attitudes toward medication, affect treatment adherence in individuals with rapid cycling 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. Rapid cycling bipolar disorder (RCBPD) is a type of BPD in which the individual experiences four or more episodes of mania and depression per year. The rapid shift between the manic and depressive episodes makes it imperative that individuals with RCBPD strictly manage their illness with medication. 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 RCBPD 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 study will consist of 1 visit, which will last approximately 2 and ½ hours and will include an anthropological interview and numerous standardized psychological questionnaires. The interview and questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; expectations regarding recovery, stigma, and quality of life; and medication adherence.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualitative Interview | – | –Participants with rapid cycling bipolar disorder (RCBPD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population includes 20 individuals receiving treatment at an academic medical center and 20 individuals seeking treatment at a community mental health clinic.
Key inclusion criteria (4 listed)
- Clinical diagnosis of rapid cycling variant of bipolar disorder type I; diagnosed 2 to 20 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
- 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
The Subjective Experience of Medication Interview (SEMI)
Time frame: Baseline
The Subjective Experience of Medication Interview (SEMI) is a qualitative, semi-structured assessment of subjective experience of mental illness, which requires approximately 60-120 minutes to administer. Illness experience domains assessed include illness attitudes, attributions and behaviors, social relations, treatment history and medication experience, self-medication, quality of life, stigma, culture/ethnicity, and health care logistics. The SEMI has been modified for use in populations with Bipolar Disorder.
7 secondary outcomes
Hamilton Depression Rating Scale (HAMD)
Time frame: Baseline
Clinical Global Impression (CGI)
Time frame: Baseline
Insight and Treatment Attitudes Questionnaire (ITAQ)
Time frame: Baseline
Illness Behavior Questionnaire (IBQ)
Time frame: Baseline
Attitude Towards Mood Stabilizers Questionnaire (AMSQ)
Time frame: Baseline
Multidimensional Health Locus of Control Scale (MHLC)
Time frame: Baseline
Treatment Adherence
Time frame: Baseline
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 6 Feb 2019.
- Results publication: PubMed 18996600Sajatovic M, Jenkins JH, Cassidy KA, Muzina DJ. Medication treatment perceptions, concerns and expectations among depressed individuals with Type I Bipolar Disorder. J Affect Disord. 2009 Jun;115(3):360-6. doi: 10.1016/j.jad.2008.10.002. Epub 2008 Nov 8.
- Results publication: PubMed 18070834Sajatovic M, Jenkins JH, Safavi R, West JA, Cassidy KA, Meyer WJ, Calabrese JR. Personal and societal construction of illness among individuals with rapid-cycling bipolar disorder: a life-trajectory perspective. Am J Geriatr Psychiatry. 2008 Sep;16(9):718-26. doi: 10.1097/JGP.0b013e3180488346. Epub 2007 Dec 10.
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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
2 sites 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 2 sites 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 4 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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The Subjective Experience of Medication Interview (SEMI) (time frame: Baseline). 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 NCT00183703, which also lists 2 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 6 Feb 2019.