Many well-controlled trials in the past 4 years have evaluated new medications for treating bipolar disorder. It’s time to build a consensus on how this data may apply to clinical practice.
This year, our group will re-examine the Texas Medication Algorithm Project (TMAP) treatment algorithms for bipolar I disorder.
What makes TMAP unique? It is the first project to evaluate treatment algorithm use in community mental health settings for patients with a history of mania (see Box).1-5 Severely, persistently ill outpatients such as these are seldom included in research but are frequently seen in clinical practice.
To preview for psychiatrists the changes expected in 2004, this article describes the goals of TMAP and the controlled study on which the medication algorithms are based. We review the medication algorithms of 2000 as a starting point and present the evidence that is changing clinical practice.
Guiding principles of TMAP
A treatment algorithm is no substitute for clinical judgment; rather, medication guidelines and algorithms are guideposts to help the clinician and patient collaboratively develop the most effective medication strategy with the fewest side effects.
TMAP goals: Best patient outcomes, best use of health care resources
The Texas Medication Algorithm Project (TMAP)1-3 is a public and academic collaboration started in 1996 to develop evidence- and consensus-based medication treatment algorithms for schizophrenia, major depressive disorder, and bipolar disorder.
TMAP’s goal is to establish “best practices” to encourage uniformity of care, achieve the best possible patient outcomes, and use mental health care dollars most efficiently. The project includes four phases, in which the treatment algorithms were developed, compared with treatment-as-usual, put into practice, and will undergo periodic updates.4 The next update begins this year.
The comparison of algorithms for treating bipolar mania/hypomania and depression included 409 patients (mean age 38 to 40) with bipolar I disorder or schizoaffective disorder, bipolar type. These patients were severely and persistently mentally ill, from a diverse ethnic population, and significantly impaired in functioning.
During 12 months of treatment, psychiatric symptoms diminished more rapidly in patients in the algorithm group—as measured by the Brief Psychiatric Rating Scale (BPRS-24)—compared with those receiving usual treatment. After the first 3 months, the usual-treatment patients also showed diminished symptoms. At study’s end, symptom severity between the groups was not significantly different; both groups showed improvement.
Manic and psychotic symptoms—measured by Clinician-Administered Rating Scale subscales (CARS-M)5—improved significantly more in the algorithm group in the first 3 months, and this gap between the two groups was sustained for 12 months. Depressive symptoms declined, but no overall differences were noted between the two groups. Side effect rates and functioning were also similar.
TMAP’s treatment manual (see Related resources) describes clinicians’ preferred tactics and decision points, which we summarize here. The guidelines are an ongoing effort to apply evidence-based medicine to everyday practice and are meant to be adapted to patient needs.
Treatment goals that guided TMAP algorithm development are:
- symptomatic remission
- full return of psychosocial functioning
- prevention of relapse and recurrence.
Suggestions came from controlled clinical trials, open trials, retrospective data analyses, expert clinical consensus, and input from consumers.
Treatment selection. Initial algorithm stages recommend simple treatments (in terms of safety, tolerability, and side effects), whereas later stages recommend more-complicated regimens. A patient’s symptoms, comorbid conditions, and treatment history guide treatment selection. Patients may enter an algorithm at any stage, depending on their clinical presentation and medication history.
The clinician may consider patient preference when deciding among equivalent medications. The algorithm strongly encourages patients and families to participate, such as by keeping daily mood charts and completing symptom and side-effect checklists. When clinicians face a choice among medication brands, generics, or forms (such as immediate- versus slow-release), agents with greater tolerability are preferred.
Patient management. When patients enter the algorithm, clinic visits are frequent (such as every 2 weeks). Follow-up appointments address medication adherence, dosage adjustments, and side effects or adverse reactions.
If a patient’s symptoms show no change after two treatment stages, re-evaluate the diagnosis and consider mitigating factors such as substance abuse. Patients who complete acute treatment should receive continuation treatment.
Documentation. Clinicians are advised to document decision points and the rationale for treatment choices made outside the algorithm package.
Treating mania or hypomania
After clinical evaluation confirms the diagnosis of bipolar illness,4 the TMAP mania/hypomania algorithm (Algorithm 1) splits into three treatment pathways:
- euphoric mania/hypomania
- mixed or dysphoric mania/hypomania
- psychotic mania.
These pathways recognize the need for differing approaches to initial monotherapy and later two-drug combinations. If a patient develops persistent or severe depressive symptoms, the bipolar algorithm for a major depressive episode (Algorithm 2) is used during depressive periods with the primary mania algorithm.