Research report
The Stanley Foundation Bipolar Treatment Outcome Network: II. Demographics and illness characteristics of the first 261 patients

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Abstract

Background: Since recent NIMH Bipolar Disorder Workshops highlighted the dearth of longitudinal and controlled studies of bipolar illness, the Stanley Foundation Bipolar Network (SFBN) has recruited a large cohort of patients with bipolar disorder to begin to address these issues. This report describes the demographics and course of illness characteristics of this study population. Methods: The first 261 outpatients to be diagnosed by the Structured Clinical Interview for DSM-IV (SCID) and complete a detailed patient and a brief clinician questionnaire are described. All patients met DSM-IV criteria for bipolar I (n=211), bipolar II (n=42), or NOS (n=5) or schizoaffective (n=3), bipolar type. Chi-square and t-tests were used to examine statistically significant associations among important demographic and descriptive items. Results: The general demographic and illness characteristics were similar to those in many bipolar clinical samples and not dissimilar from those reported in epidemiological surveys. The majority of patients had been hospitalized, with almost half reporting a worsening of illness over time, and two-thirds were not asymptomatic between episodes. First treatment for patients had been delayed by an average of 10 years from illness onset (by SCID). Almost a third of patients had attempted suicide at least once, and 30% reported current suicidal ideation at study entry. A total of 62% reported moderate to severe impact of the illness on occupational functioning. Early onset bipolar illness (≤17 years old) was associated with increased frequency of mood switches, worsening course of illness, and history of early abuse (physical, verbal, or sexual). Conclusion: The SFBN represents a sample of predominantly BP I patients largely recruited from the community who will be followed in detail longitudinally, participate in clinical trials, and thus help advance our understanding and treatment of this life-threatening medical disorder. While there is a broad range of illness characteristics and severity, the majority of patients have been severely impacted by their illness despite the availability of multiple conventional treatment approaches in the community. These data further underscore the need for development of new and earlier treatment interventions. Limitation: The SFBN population is limited by the lack of random selection and represents a cohort willing to be treated and followed intensively in academic tertiary referral centers. While its characteristics are similar to many clinical study populations, the generalizability to non-clinic populations remains uncertain.

Introduction

The National Institute of Mental Health Bipolar Disorder Workshops of 1989 and 1994 emphasized the need for greater research on bipolar illness (Prien and Potter, 1990, Prien and Rush, 1996). They focused on the problem of limited data from controlled clinical trials which would help define best treatments for all aspects of the illness, but particularly for bipolar depression and the maintenance phase of the illness. Among the recommendations to emerge from these NIMH workshops was the development of a consortium of academic centers, patient advocacy groups, and the pharmaceutical industry, to increase the number and representativeness of patients in study populations and controlled clinical trials, and to help develop methods and assessment devices that would accurately describe illness course and be acceptable to review committees.

There are intrinsic difficulties in studying patients with bipolar disorder, in particular — as recognized in the recent DSM-IV — the heterogeneity of the illness including bipolar I and II (American Psychiatric Association, 1994), as well as mixed or dysphoric mania and a great many course specifiers (Post et al., 1998). Additionally, the illness is characterized by unpredictability such that the presentation may vary broadly across the population and within individuals (Kraepelin, 1921, Roy-Byrne et al., 1985, Coryell et al., 1992, Akiskal et al., 1995, Kramlinger and Post, 1996). Most longitudinal studies of patients with bipolar disorder, many of which have made substantial contributions to the understanding of the illness, have, nevertheless, been limited by infrequent follow-up periods and lack of systematic clinical outcome measures (Morrison et al., 1973).

The Stanley Foundation Bipolar Network (SFBN or Network), a group of clinical research centers dedicated to the study of patients with bipolar disorder, was established in 1994 in order to address many of the priorities raised at the NIMH workshops. The Network rationale and methods are discussed in detail in a companion article in this issue of the journal (Leverich et al., 2001, this issue).

In brief, the SFBN recruited (and continues to recruit) a large cohort of patients with bipolar disorder for longitudinal study and treatment using uniform measures and clinical evaluations. Patients are followed long-term, at a minimum of monthly visits, with recognized, well-validated cross-sectional rating scales and daily prospective life chart ratings (Leverich et al., 2001, this issue; Leverich and Post, 1996, Leverich and Post, 1998). Additionally, they are offered participation in randomized open or blind clinical trials and treatment as appropriate to the current status of their illness.

This paper describes the characteristics of the first 261 patients who entered the SFBN. The demographic and clinical characteristics of these patients, including diagnoses (McElroy et al., 2001), illness variables (Leverich et al., 2002), and family history are presented and discussed. This initial report provides the basis for further descriptive studies of Axis I and II comorbidity, longitudinal follow-up, and response to treatment (in randomized or open clinical trials from the SFBN) in a large cohort of well-described patients with bipolar illness.

Section snippets

Methods

The Stanley Foundation Bipolar Network (SFBN or Network) consists of four sites in the United States (Los Angeles, Dallas, Cincinnati, and Bethesda) and one site in Europe (Utrecht, Netherlands) (see Leverich et al., 2001, this issue, for a detailed review of methods). Patients recruited into the Network were outpatients referred from within each site’s clinic or new patients joining the clinic. In many cases, patients were referred by local physicians or by self-referral from local advocacy

Demographic and socioeconomic characteristics

Table 1 displays sex, ethnicity, age, and marital status of the SFBN patient group in comparison to other major patient and population samples. In particular, the gender distribution was the closest of the comparison groups to the US population. The ethnic distribution of patients was not diverse, with over 90% of Anglo-European (Caucasian) descent, and the major underrepresented group relative to the US population was African-American. Age distribution was similar to that in the NDMDA survey (

Discussion

The first 261 patients to enter the SFBN are described including their SCID-based diagnosis and questionnaire-based demographics, family history, and illness course characteristics. These data, in conjunction with the detailed reports of the considerable Axis I (McElroy et al., 2001) and Axis II (Leverich et al., 2000) comorbidity, provide a descriptive basis for later reports which will examine prognostic indicators, the impact of standard and novel treatments, and potential predictors of

Acknowledgements

This study was also supported by a grant from the Theodore and Vada Stanley Foundation.

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