• Home
  • Store
    • Newsletter Subscriptions
    • Multimedia
    • Books
    • eBooks
    • ABPN SA Courses
    • Social Work Courses
  • CME Center
  • Multimedia
    • Podcast
    • Webinars
    • Blog
    • Psychiatry News Videos
    • Medication Guide Videos
  • Newsletters
    • General Psychiatry
    • Child Psychiatry
    • Addiction Treatment
    • Hospital Psychiatry
    • Geriatric Psychiatry
    • Psychotherapy and Social Work
  • FAQs
  • Med Fact Book App
  • Log In
  • Register
  • Welcome
  • Sign Out
  • Subscribe
Home » The STEP-BD Study: An Introduction

The STEP-BD Study: An Introduction

August 1, 2006
From The Carlat Psychiatry Report
Issue Links: Learning Objectives | Editorial Information | PDF of Issue

The STEP-BD study, an NIMH-funded study of bipolar disorder, has enrolled its last patient, and we have already begun to see the first results filtering through to the psychiatric journals.

STEP-BD stands for “Systematic Treatment Enhancement Program for Bipolar Disorder,” and it is the latest installment in a recent trend in psychiatric research known as “effectiveness studies.” These studies have in common an effort to enroll large numbers of real world patients, using few exclusion criteria, in order to make the results more generalizable to our practices. In prior issues, we have reviewed two other effectiveness trials: the CATIE trial (TCPR Feb 2006) and the STAR-D trial ( TCPR May 2006).

The STEP-BD study enrolled a total of 4,360 patients. In order to be enrolled, patients merely had to meet criteria for bipolar disorder I, II, NOS, or cyclothymia. They could be teetotalers or substance abusers, high-powered executives or chronically homeless. There were essentially no exclusion criteria.

On study entry, patients were assigned a “STEP-BD-certified” psychiatrist. These psychiatrists received 20 hours of training on best practice procedures for how to treat patients with bipolar disorder. These “best practices” were written by a committee of bipolar disorder experts, who identified nine different clinical decision points corresponding to nine common clinical situations in the treatment of bipolar patients. At each decision point, there is a defined Standard Care Pathway with a “menu of reasonable choices.” This is not really a strict treatment algorithm, but rather a series of loose guidelines meant to point treaters in the appropriate directions.

Patients were seen every three months for the first year, then every six months thereafter. They were encouraged to stay in the trial for five years.

The first three major STEP-BD findings

1.Even gold-standard treatment isn’t terribly effective. One of the first papers focused on 1469 patients who had been followed for two years (Am J Psychiatry 2006;163:217-224). After up to two years of best practices treatment, 58.4% of these patients met criteria for full recovery, defined as not meeting more than two DSM-IV criteria for depression or mania for eight consecutive weeks. Note that this is a much more stringent outcome measure than is typically used in controlled trials, in which “response” is measured as a 50% reduction in symptoms at a single time point. The group of 858 patients who recovered by STEP-BD criteria were observed further, and 48.5% of them suffered a recurrence at some point during the study (416 patients), more commonly to a depressive episode (72%) than to a manic, hypomanic, or mixed episode (28%). Not surprisingly, having residual symptoms was associated with a greater chance of recurrence.

What are the practical implications of these data? Patients who present to a bipolar disorder specialist in an acute episode of bipolar disorder (depressed or manic), have slightly better than a 50/50 chance of recovering in two years. Once recovered, there is a 50% chance of relapsing. This may not sound very heartening, but Gary Sachs, STEP-BD’s lead investigator, takes a more optimistic view of the data in this month’s interview (pages 5-6).

2. For treatment-refractory bipolar depression, Lamictal and Inositol beat Risperdal. The STEP-BD study randomly assigned treatment-refractory patients with bipolar depression to one of three adjunctive treatments: lamotrigine (up to 250 mg QD), inositol (up to 25 g QD), or risperidone (up to 6 mg QD) for up to 16 weeks (Am J Psychiatry 2006;163:210-216). All patients were already on a mood stabilizer (lithium, Depakote, or Tegretol) and one or two antidepressants. The recovery rates were: Lamictal, 23.8%, inositol, 17.4%, risperidone, 4.6%. While these numbers may look different, the differences aren’t statistically significantly because of the small number of subjects. Nonetheless, it’s a bit humiliating for Risperdal, which could not outperform inositol, an isomer of glucose that is used by our neurons transmitting information from neurotransmitters.

3. Yes, Depakote really does cause polycystic ovariansyndrome. It’s a notion that has been around for a while: Depakote may increase the risk of developing polycystic ovarian syndrome (PCOS). While a prior study of bipolar women suggested that this happens, the sample was not high enough to yield a statistically significant result. The large sample size of STEP-BD allowed investigators to evaluate 230 women (ages 18-44) for the development of symptoms of PCOS (menstrual irregularities, hirsutism, acne, male-pattern hair loss, elevated testosterone). They found PCOS symptoms in nine of 86 women on valproate (10.5%) as opposed to only two of 144 women on a nonvalproate anticonvulsant or lithium (1.4%). The upshot? Warn woman about these potential side effects before starting them on Depakote (Biol Psychiatry 2006;59:1078-1086).

TCPR Verdict:
STEP-BD -- the findings are rolling out.
General Psychiatry
KEYWORDS bipolar_disorder
    www.thecarlatreport.com
    Issue Date: August 1, 2006
    SUBSCRIBE NOW
    Table Of Contents
    Bipolar Disorder in Children: Is the Diagnosis Valid?
    The STEP-BD Study: An Introduction
    Do Antidepressants Cause Switching?
    Bipolar II Disorder: A Useful Concept?
    Understanding the STEP-BD Study
    CATIE, STAR*D, STEP-BD
    DOWNLOAD NOW
    Featured Book
    • MFB7e_Print_App_Access.png

      Medication Fact Book for Psychiatric Practice, Seventh Edition (2024) - Regular Bound Book

      The updated 2024 reference guide covering the most commonly prescribed medications in psychiatry.
      READ MORE
    Featured Video
    • KarXT (Cobenfy)_ The Breakthrough Antipsychotic That Could Change Everything.jpg
      General Psychiatry

      KarXT (Cobenfy): The Breakthrough Antipsychotic That Could Change Everything

      Read More
    Featured Podcast
    • shutterstock_2622607431.jpg
      General Psychiatry

      Should You Test MTHFR?

      MTHFR is a...
      Listen now
    Recommended
    • Join Our Writing Team

      July 18, 2024
      WriteForUs.png
    • Insights About a Rare Transmissible Form of Alzheimer's Disease

      February 9, 2024
      shutterstock_2417738561_PeopleImages.com_Yuri A.png
    • How to Fulfill the DEA's One Time, 8-Hour Training Requirement for Registered Practitioners

      May 24, 2024
      DEA_Checkbox.png
    • Join Our Writing Team

      July 18, 2024
      WriteForUs.png
    • Insights About a Rare Transmissible Form of Alzheimer's Disease

      February 9, 2024
      shutterstock_2417738561_PeopleImages.com_Yuri A.png
    • How to Fulfill the DEA's One Time, 8-Hour Training Requirement for Registered Practitioners

      May 24, 2024
      DEA_Checkbox.png
    • Join Our Writing Team

      July 18, 2024
      WriteForUs.png
    • Insights About a Rare Transmissible Form of Alzheimer's Disease

      February 9, 2024
      shutterstock_2417738561_PeopleImages.com_Yuri A.png
    • How to Fulfill the DEA's One Time, 8-Hour Training Requirement for Registered Practitioners

      May 24, 2024
      DEA_Checkbox.png

    About

    • About Us
    • CME Center
    • FAQ
    • Contact Us

    Shop Online

    • Newsletters
    • Multimedia Subscriptions
    • Books
    • eBooks
    • ABPN Self-Assessment Courses

    Newsletters

    • The Carlat Psychiatry Report
    • The Carlat Child Psychiatry Report
    • The Carlat Addiction Treatment Report
    • The Carlat Hospital Psychiatry Report
    • The Carlat Geriatric Psychiatry Report
    • The Carlat Psychotherapy Report

    Contact

    carlat@thecarlatreport.com

    866-348-9279

    PO Box 626, Newburyport MA 01950

    Follow Us

    Please see our Terms and Conditions, Privacy Policy, Subscription Agreement, Use of Cookies, and Hardware/Software Requirements to view our website.

    © 2025 Carlat Publishing, LLC and Affiliates, All Rights Reserved.