July 7, 2004 — Patients treated with an algorithm-based program for major depressive disorder (MDD) had better outcomes than those treated with usual care, according to the results of a prospective trial published in the July issue of the Archives of General Psychiatry.
"Because no one treatment is a panacea, clinicians often use a sequence of treatment steps (either monotherapies or combinations) to increase the likelihood of response or remission," write Madhukar H. Trivedi, MD, from the University of Texas Southwestern Medical Center in Dallas, and colleagues. "Decision tree-based algorithms hold the promise of increased consistency of treatment across practitioners, which in turn should lead to better clinical outcomes and more efficient use of health care resources."
The Texas Medication Algorithm project compared algorithm-guided treatment (ALGO) for MDD with treatment as usual (TAU) in four ALGO clinics, six TAU clinics, and four clinics offering TAU to patients with MDD but ALGO to patients with schizophrenia or bipolar disorder.
Outpatients with MDD were divided into ALGO and TAU groups. The ALGO group included patients who were starting antidepressant therapy or who needed a change of antidepressant medication. The TAU group initially met the same criteria. Because medication changes were less frequent in the TAU group, patients were also recruited if their Brief Psychiatric Rating Scale (BPRS) total score was higher than the median for that clinic's routine quarterly evaluation of each patient.
All patients improved during the one-year study (P < .001). However, ALGO patients had significantly greater symptom reduction than TAU patients on the 30-item Inventory of Depressive-Symptomatology Clinician Rated (IDS-C30) scale, the 30-item Inventory of Depressive Symptomatology-Self-Report (IDS-SR30) scale, and 12-item Short-Form Health Survey (SF-12) mental health score (P = .046).
Study limitations include lack of randomization, lack of blinding of the outcome assessors, and varying degrees of algorithm adherence.
"The ALGO intervention package during one year was superior to TAU for patients with MDD based on clinician-rated and self-reported symptoms and overall mental functioning," the authors write. "At the practitioner level, we need to explore mechanisms to increase algorithm adherence, including academic detailing, continuous quality improvement, and computerized decision support systems."
The National Institutes of Mental Health and various governmental agencies, pharmaceutical companies, and private foundations supported this project and some of its investigators.
Arch Gen Psych. 2004;61:669-680
Learning Objectives for This Educational Activity
Upon completion of this activity, participants will be able to: Describe components of the ALGO vs. TAU intervention for patients with MDD.Compare the effect of the ALGO intervention with TAU in an outpatient psychiatric setting.
MDD affects 7% to 12% of men and 20% to 25% of women in their lifetime. Ten percent to 30% of those with MDD have a chronic course with episodes that last two or more years. MDD accounts for up to 60% of psychiatric hospitalizations and 8% to 15% of patients commit suicide. Patients in the U.S. public mental health sector tend to have severe symptoms, poor daily functioning, concurrent medical conditions, and alcohol and other substance abuse. Undertreatment is common and adherence to therapy is a problem. Efficacy trials indicate that one third of patients respond to medications with remission in six to eight weeks with higher remission rates in longer trials. One study by Hirschfield and colleagues published in the September 2001 issue of the British Journal of Psychiatry reported that in the longer term 10% to 30% of patients who do not respond to initial treatment, subsequently, develop depressive relapses within four to six months. Few studies have addressed the optimal management of patients with unsatisfactory clinical responses.
The authors of this descriptive longitudinal study offered an ALGO intervention compared with the TAU approach to MDD patients in the public health mental sector attending 14 psychiatric outpatient clinics to examine the one-year impact on clinician and patient-rated depression and quality-of-life outcomes.
ALGO is an enriched disease-management model that includes a set of physician protocols addressing medication management (using a manual, didactic training, and biweekly telephone expert consultation), on-site clinical coordinator support for patient services, patient and family education program with a manual for the patient, for MDD patients with and without psychosis. Decision points are at weeks 4, 6, 8, 10, and 12. Goals are to enhance adherence and optimal medication selection and dosage with minimal adverse-effect burden.
Patients from 4 clinics offering ALGO were compared with those from 6 clinics offering TAU only and 4 offering ALGO to patients with schizophrenia and bipolar disorder but not MDD patients for one year.8 of 14 clinics were rural in setting. Ethnicity was described as 12% to 90% white, 2% to 86% Hispanic, and 0.3% to 58% black across the 14 clinics.Inclusion criteria were older than 18 years, psychotic or nonpsychotic MDD requiring medication change, starting antidepressant therapy, or higher than median BPRS-24 score.Exclusion criteria were schizophrenia, bipolar disorder, mental retardation, or primary diagnosis of obsessive compulsive or eating disorder and inpatient detoxification at time of study.Both groups had equal access to the same medications. The TAU group received nonprotocol-driven usual care as determined by patient needs at each visit.Physician adherence to ALGO protocols was not reported. Assessors of outcomes were not blinded to assignment.Primary outcome was change in clinician-assessed IDS-C30 score. A 4.4-point difference in this score is equivalent to a 3-point difference on the Hamilton Rating Scale for Depression.Secondary outcomes were IDS-SR30, BPRS-24, patient-rated health-related quality of life using the SF-12-Mental Health Summary and Patient Perception of Benefits instrument, and burden of adverse effects.Percentage of patients available for analyses were 100% at 3 months, 99.5% at 6 months, 83.2% at 9 months, and 75.9% at 12 months. The analytic sample (intent-to-treat) consisted of 175 in the ALGO and 175 in the TAU groups.Both groups had significant declines in IDS-C30 scores, and the decline was significantly greater for ALGO than TAU patients in the first 3 months. The magnitude of difference was 4.5 points.On the IDS-SR30, there was also significantly greater symptom reduction associated with the ALGO group compared with the TAU group, with a magnitude difference of 7.5 points between the two groups.The benefits in the ALGO group for both outcomes were accounted for by patients with very severe and severe baseline IDS-C30 scores and worse functioning as indicated by the SF-12 score.By clinician rating, twice as much symptom reduction occurred with ALGO as with TAU. By patient-rating, three times as much benefit was noted by the ALGO group.Mental functioning by the SF-12- Mental Health Summary instrument improved significantly more with the ALGO than the TAU group, with no discernable catch up by the TAU group for one year.Even among responders, substantial symptoms remained at the end of one year.Differences in growth rates in adverse effects during follow-up were not significantly different.
Pearls for Practice
The ALGO intervention model for patients with MDD included a set of physician protocols addressing medication management, on-site clinical coordinator support for patient services, and patient and family education program with a manual for the patient. The TAU group received nonprotocol-driven usual care for MDD as determined by patient needs at each visit.The ALGO intervention for one year is associated with significantly better clinician and patient-reported symptom control, therapy adherence, and quality of life compared with TAU for MDD patients in the public sector.
This is a part of article Algorithm-Based Program Effective for Major Depressive Disorder Taken from "Celexa Citalopram 10Mg" Information Blog