Bipolar DisorderPhase 3NCT00007761
Does Bipolar Disease Program (BDP) Intervention Improve Long Term Manic and Depressive Symptoms.
A Phase 3 study testing Bipolar Disorder Program and Usual (psychiatric) Care in people with Bipolar Disorder, run by US Department of Veterans Affairs at 13 sites in United States.
Trial summary
Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Bipolar Disorder Program and Usual (psychiatric) Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 1997to Dec 2003
- Phase
- Phase 3
- 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
Who may be able to join
- Patients with bipolar disorder. Index episode of manic, major depression or both requiring hospitalization on acute unit. At lease two hospitalizations, three or more months apart within the past 5 years.
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
VA Medical Center, Augusta
Augusta, Georgia, 30904
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, 02301
VA Medical Center, Cleveland
Cleveland, Ohio, 44106
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884
James H. Quillen VA Medical Center
Mountain Home, Tennessee, 37684
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, 85723
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
About this study
Official title: CSP #430 - Reducing The Efficacy-Effectiveness Gap In Bipolar Disorder
Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. The major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.
Read the detailed description
Primary Hypothesis: The primary hypotheses are that Bipolar Disease Program (BDP) intervention will significantly improve (1) manic and (2) depressive symptom scores, as well as Total Treatment Costs as compared to usual care of bipolar patients.
Secondary Hypothesis: Secondary hypotheses include significant improvement in BDP patients as compared to usual bipolar treatment care with respect to functional outcome, quality of life, intensity of somatotherapy, patient satisfaction, and provider attitudes.
Intervention: Usual (psychiatric) Care vs Bipolar Disorder Program
Primary Outcomes: The primary outcomes are: (1) Manic Symptom Score; (2) Depressive Symptom Score; and (3) Total Treatment Costs.
Study Abstract: Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. The major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.
Patients with bipolar disorder will be randomly assigned to either standard care or the high intensity ambulatory program for three years. Outcome variables will cover three distinct domains: disease-specific outcome (number, length, and severity of manic and depressive episodes), functional outcome (social and occupational role function and subjective quality of life), and total treatment costs (direct treatment costs and indirect costs of illness). Preliminary data indicate that these domains are related but not redundant. Each of these is relevant to patient well-being and to VHA management.
- Conditions
- Bipolar Disorder
- Being tested
- Bipolar Disorder Program, Usual (psychiatric) Care
- Keywords
- Bipolar Disease Program intervention
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar Disorder ProgramBehavioural
Usual (psychiatric) CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bipolar Disorder Program Receives: Behavioral: Bipolar Disorder Program |
| 2 | Active comparator | Usual (psychiatric) Care Receives: Behavioral: Usual (psychiatric) Care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2001 (estimated)
- Study startJul 1997
- Primary completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)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
- Interventional
- Phase
- Phase 3
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Mark S Bauer, MD BA, Study chair, VA Boston Healthcare System, Brockton Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007761
- Sponsor's protocol ID
- 430
- Status last verified
- Sep 2009
- First submitted
- 29 Dec 2000
- Last updated
- 24 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Pirraglia PA, Biswas K, Kilbourne AM, Fenn H, Bauer MS. A prospective study of the impact of comorbid medical disease on bipolar disorder outcomes. J Affect Disord. 2009 Jun;115(3):355-9. doi: 10.1016/j.jad.2008.09.020. Epub 2008 Oct 18.
PubMed 18930558Brown GR, McBride L, Bauer MS, Williford WO; Cooperative Studies Program 430 Study Team. Impact of childhood abuse on the course of bipolar disorder: a replication study in U.S. veterans. J Affect Disord. 2005 Dec;89(1-3):57-67. doi: 10.1016/j.jad.2005.06.012. Epub 2005 Oct 4.
PubMed 16213029Bauer MS, Williford WO, McBride L, McBride K, Shea NM. Perceived barriers to health care access in a treated population. Int J Psychiatry Med. 2005;35(1):13-26. doi: 10.2190/U1D5-8B1D-UW69-U1Y4.
PubMed 15977942Bauer MS, Altshuler L, Evans DR, Beresford T, Williford WO, Hauger R; VA Cooperative Study #430 Team. Prevalence and distinct correlates of anxiety, substance, and combined comorbidity in a multi-site public sector sample with bipolar disorder. J Affect Disord. 2005 Apr;85(3):301-15. doi: 10.1016/j.jad.2004.11.009.
PubMed 15780700Bauer MS, Mitchner L. What is a "mood stabilizer"? An evidence-based response. Am J Psychiatry. 2004 Jan;161(1):3-18. doi: 10.1176/appi.ajp.161.1.3.
PubMed 14702242Glick HA, McBride L, Bauer MS. A manic-depressive symptom self-report in optical scanable format. Bipolar Disord. 2003 Oct;5(5):366-9. doi: 10.1034/j.1399-5618.2003.00043.x.
PubMed 14525558Bauer MS. An evidence-based review of psychosocial treatments for bipolar disorder. Psychopharmacol Bull. 2001 Summer;35(3):109-34.
PubMed 12397882Bauer MS. A review of quantitative studies of adherence to mental health clinical practice guidelines. Harv Rev Psychiatry. 2002 May-Jun;10(3):138-53. doi: 10.1080/10673220216217.
PubMed 12023929Bauer MS. The collaborative practice model for bipolar disorder: design and implementation in a multi-site randomized controlled trial. Bipolar Disord. 2001 Oct;3(5):233-44. doi: 10.1034/j.1399-5618.2001.30502.x.
PubMed 11903206Bauer MS, Kirk GF, Gavin C, Williford WO. Determinants of functional outcome and healthcare costs in bipolar disorder: a high-intensity follow-up study. J Affect Disord. 2001 Aug;65(3):231-41. doi: 10.1016/s0165-0327(00)00247-0.
PubMed 11511403Vojta C, Kinosian B, Glick H, Altshuler L, Bauer MS. Self-reported quality of life across mood states in bipolar disorder. Compr Psychiatry. 2001 May-Jun;42(3):190-5. doi: 10.1053/comp.2001.23143.
PubMed 11349236Bauer MS, Vojta C, Kinosian B, Altshuler L, Glick H. The Internal State Scale: replication of its discriminating abilities in a multisite, public sector sample. Bipolar Disord. 2000 Dec;2(4):340-6. doi: 10.1034/j.1399-5618.2000.020409.x.
PubMed 11252648Sajatovic M, Biswas K, Kilbourne AK, Fenn H, Williford W, Bauer MS. Factors associated with prospective long-term treatment adherence among individuals with bipolar disorder. Psychiatr Serv. 2008 Jul;59(7):753-9. doi: 10.1176/ps.2008.59.7.753.
PubMed 18586992Altshuler L, Tekell J, Biswas K, Kilbourne AM, Evans D, Tang D, Bauer MS. Executive function and employment status among veterans with bipolar disorder. Psychiatr Serv. 2007 Nov;58(11):1441-7. doi: 10.1176/ps.2007.58.11.1441.
PubMed 17978254Bauer MS, McBride L, Williford WO, Glick H, Kinosian B, Altshuler L, Beresford T, Kilbourne AM, Sajatovic M; Cooperative Studies Program 430 Study Team. Collaborative care for bipolar disorder: Part II. Impact on clinical outcome, function, and costs. Psychiatr Serv. 2006 Jul;57(7):937-45. doi: 10.1176/ps.2006.57.7.937.
PubMed 16816277
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #430 - Reducing The Efficacy-Effectiveness Gap In Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00007761
- Acronym / sponsor ID
- 430
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disease Program intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 1997
- Primary completion
- Dec 2003 (actual)
- First posted
- 1 Jan 2001 (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.
Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. The major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.
Detailed description
Primary Hypothesis: The primary hypotheses are that Bipolar Disease Program (BDP) intervention will significantly improve (1) manic and (2) depressive symptom scores, as well as Total Treatment Costs as compared to usual care of bipolar patients.
Secondary Hypothesis: Secondary hypotheses include significant improvement in BDP patients as compared to usual bipolar treatment care with respect to functional outcome, quality of life, intensity of somatotherapy, patient satisfaction, and provider attitudes.
Intervention: Usual (psychiatric) Care vs Bipolar Disorder Program
Primary Outcomes: The primary outcomes are: (1) Manic Symptom Score; (2) Depressive Symptom Score; and (3) Total Treatment Costs.
Study Abstract: Based on highly promising preliminary data, it is proposed to conduct a multi-site randomized controlled trial of a high-intensity ambulatory treatment program for bipolar disorder against standard office-based, physician-centered care. The major characteristics of this program are that it emphasizes (1) aggressive guideline-driven pharmacotherapy, (2) continuity of care with identified primary mental health nurse clinicians supported by psychiatrist back-up, and (3) patient education to improve treatment alliance and illness management skills.
Patients with bipolar disorder will be randomly assigned to either standard care or the high intensity ambulatory program for three years. Outcome variables will cover three distinct domains: disease-specific outcome (number, length, and severity of manic and depressive episodes), functional outcome (social and occupational role function and subjective quality of life), and total treatment costs (direct treatment costs and indirect costs of illness). Preliminary data indicate that these domains are related but not redundant. Each of these is relevant to patient well-being and to VHA management.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Bipolar Disorder ProgramBipolar Disorder Program |
| 2 | Active comparator | Behavioral: Usual (psychiatric) CareUsual (psychiatric) Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with bipolar disorder. Index episode of manic, major depression or both requiring hospitalization on acute unit. At lease two hospitalizations, three or more months apart within the past 5 years.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bipolar Disorder Program | Behavioural | 1 |
| Usual (psychiatric) Care | Behavioural | 2 |
Primary outcome
Not reported in the source record.
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 24 Sep 2009.
- Results publication: PubMed 18930558Pirraglia PA, Biswas K, Kilbourne AM, Fenn H, Bauer MS. A prospective study of the impact of comorbid medical disease on bipolar disorder outcomes. J Affect Disord. 2009 Jun;115(3):355-9. doi: 10.1016/j.jad.2008.09.020. Epub 2008 Oct 18.
- Results publication: PubMed 16213029Brown GR, McBride L, Bauer MS, Williford WO; Cooperative Studies Program 430 Study Team. Impact of childhood abuse on the course of bipolar disorder: a replication study in U.S. veterans. J Affect Disord. 2005 Dec;89(1-3):57-67. doi: 10.1016/j.jad.2005.06.012. Epub 2005 Oct 4.
- Results publication: PubMed 15977942Bauer MS, Williford WO, McBride L, McBride K, Shea NM. Perceived barriers to health care access in a treated population. Int J Psychiatry Med. 2005;35(1):13-26. doi: 10.2190/U1D5-8B1D-UW69-U1Y4.
- Results publication: PubMed 15780700Bauer MS, Altshuler L, Evans DR, Beresford T, Williford WO, Hauger R; VA Cooperative Study #430 Team. Prevalence and distinct correlates of anxiety, substance, and combined comorbidity in a multi-site public sector sample with bipolar disorder. J Affect Disord. 2005 Apr;85(3):301-15. doi: 10.1016/j.jad.2004.11.009.
- Results publication: PubMed 14702242Bauer MS, Mitchner L. What is a "mood stabilizer"? An evidence-based response. Am J Psychiatry. 2004 Jan;161(1):3-18. doi: 10.1176/appi.ajp.161.1.3.
- Results publication: PubMed 14525558Glick HA, McBride L, Bauer MS. A manic-depressive symptom self-report in optical scanable format. Bipolar Disord. 2003 Oct;5(5):366-9. doi: 10.1034/j.1399-5618.2003.00043.x.
- Results publication: PubMed 12397882Bauer MS. An evidence-based review of psychosocial treatments for bipolar disorder. Psychopharmacol Bull. 2001 Summer;35(3):109-34.
- Results publication: PubMed 12023929Bauer MS. A review of quantitative studies of adherence to mental health clinical practice guidelines. Harv Rev Psychiatry. 2002 May-Jun;10(3):138-53. doi: 10.1080/10673220216217.
- Results publication: PubMed 11903206Bauer MS. The collaborative practice model for bipolar disorder: design and implementation in a multi-site randomized controlled trial. Bipolar Disord. 2001 Oct;3(5):233-44. doi: 10.1034/j.1399-5618.2001.30502.x.
- Results publication: PubMed 11511403Bauer MS, Kirk GF, Gavin C, Williford WO. Determinants of functional outcome and healthcare costs in bipolar disorder: a high-intensity follow-up study. J Affect Disord. 2001 Aug;65(3):231-41. doi: 10.1016/s0165-0327(00)00247-0.
- Results publication: PubMed 11349236Vojta C, Kinosian B, Glick H, Altshuler L, Bauer MS. Self-reported quality of life across mood states in bipolar disorder. Compr Psychiatry. 2001 May-Jun;42(3):190-5. doi: 10.1053/comp.2001.23143.
- Results publication: PubMed 11252648Bauer MS, Vojta C, Kinosian B, Altshuler L, Glick H. The Internal State Scale: replication of its discriminating abilities in a multisite, public sector sample. Bipolar Disord. 2000 Dec;2(4):340-6. doi: 10.1034/j.1399-5618.2000.020409.x.
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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.
Mark S Bauer, MD BA study chair
VA Boston Healthcare System, Brockton Campus
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bipolar Disorder Program and Usual (psychiatric) Care in people with Bipolar Disorder, run by US Department of Veterans Affairs at 13 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 1 inclusion and 0 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 24 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00007761, which also lists 23 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 24 Sep 2009.