Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

Treatment Resistant Depression

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

No data exist on how to address the almost 70% of patients on antidepressant medications who do not achieve symptom relief. Using a cohort of patients on approximately 1 year of SSRI medication (standard of care)it would be of great economic and medical value to determine which adjuvant treatment options provide improvements in symptom relief (e.g. remission).The recent approval of atypical antipsychotics as an expensive branded product option may not be as effective as alternative adjuvant therapies. Presently buproprion, mood stabilizers, and other medications are used in combination with SSRIs.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Adult (>18 years)patients on SSRI medications for approximately 1 year with Chronic major depressive disorder, bipolar type 2, ADD, ADHD,Obsessive compulsive disorder, anxiety disorders

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Presently, "real world" use of SSRI medications occurs in chronic dosing regimens(>1 year).Patients on long term SSRI medications are not a homogeneous population. Present data for remission only examine about 15 weeks of drug therapy with equivalent outcomes for the agents tested (see attached; STAR*D data). A treatment resistant major depressive disorder appears after long term (approx 1 year)SSRI medication in which many of the original presenting symptoms appear. Defining adequate adjuvant treatment options which can increase remission rates in long term SSRI treated patients will have a major impact on costs of care, mental health system utilization and most importantly patient outcomes.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

No comparative effectiveness data exists on adults whose depressive illness had been treated successfully with SSRIs for greater than 1 year yet exhibit a treatment resistant major depressive disorder. Defining a prospective management protocol for treatment resistant MDD will have significant impact on patient outcomes, mental health system utilization and fully burdened costs of care.

Describe any health-related risks, side effects, or harms that you are concerned about.

None

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Depression and other mental health disorders

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

None

Importance

Describe why this topic is important.

In “real world” clinical settings many patients on long term (>1 year) antidepressant medications experience a treatment resistant major depressive disorder (MDD) which remains unresolved. This treatment resistant MDD presents as a late appearing set of symptoms which include anhedonia (distinct from original presenting symptom), malaise, and an inability to engage interest in previously rewarding stimuli. No comparative effectiveness data exists on adults whose depressive illness had been treated successfully with SSRIs for approximately 1 year yet exhibit a treatment resistant major depressive disorder. Defining a prospective management protocol for treatment resistant MDD will have significant impact on both patients and the delivery system.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

I am a psychopharmacologist who is submitting SBIR grants to examine portions of this treatment resistant major depressive disorder cohort with academic associates. If funded these studies will begin to define how to approach comparative effectiveness research in treatment resistant MDD. However, SBIR funding will not support the scope of this comparative effectiveness research effort.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

There are no guidelines for effective approaches in treatment resistant major depressive disorder (approx 1 year of SSRI). An ability to identify and prospectively manage the 70% of patients on antidepressant medications who do not achieve remission will greatly advance the ability to improve treatment outcomes in major depressive disorders.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

Our research group is examining preliminary studies in how to prospectively identify those patients who are likely to experience treatment resistant major depressive disorders. The heterogeneity of an MDD diagnosis makes study design complicated. In addition, comparative effectiveness research will require combinations of therapy presently not supported by our SBIR grant submissions. Leverage of the STAR*D multicenter trials will provide an efficient platform from which to begin these important studies.

Describe the timeframe in which an answer to your question is needed.

At least 2-3 years if supported adequately.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Improvements in therapies for treatment resistant MDD will increase remission rates, decrease mental health care system utilization and dramatically decrease the fully burdened costs of care for this wide spread chronic condition.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

Our research group is examining preliminary studies in how to prospectively identify those patients who are likely to experience treatment resistant major depressive disorders. The heterogeneity of an MDD diagnosis makes study design complicated. In addition, comparative effectiveness research will require combinations of therapy presently not supported by our SBIR grant submissions. Leverage of the STAR*D multicenter trials will provide an efficient platform from which to begin these important studies.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program