Treatment and outcomes of an Australian cohort of outpatients with bipolar I or schizoaffective disorder over twenty-four months: implications for clinical practice

Abstract

Background: The Bipolar Comprehensive Outcomes Study (BCOS) is a 2-year, prospective, non-interventional, observational study designed to explore the clinical and functional outcomes associated with 'real-world' treatment of participants with bipolar I or schizoaffective disorder. All participants received treatment as usual. There was no study medication.

Methods: Participants prescribed either conventional mood stabilizers (CMS; n = 155) alone, or olanzapine with, or without, CMS (olanzapine ± CMS; n = 84) were assessed every 3 months using several measures, including the Young Mania Rating Scale, 21-item Hamilton Depression Rating Scale, Clinical Global Impressions Scale - Bipolar Version, and the EuroQol Instrument. This paper reports 24-month longitudinal clinical, pharmacological, functional, and socioeconomic data.

Results: On average, participants were 42 (range 18 to 79) years of age, 58%; were female, and 73%; had a diagnosis of bipolar I. Polypharmacy was the usual approach to pharmacological treatment; participants took a median of 5 different psychotropic medications over the course of the study, and spent a median proportion of time of 100%; of the study on mood stabilizers, 90%; on antipsychotics, 9%; on antidepressants, and 5%; on benzodiazepines/hypnotics. By 24 months, the majority of participants had achieved both symptomatic and syndromal remission of both mania and depression. Symptomatic relapse rates were similar for both the CMS alone (65%;) and the olanzapine ± CMS (61%;) cohorts.

Conclusions: Participants with bipolar I or schizoaffective disorder in this study were receiving complex medication treatments that were often discordant with recommendations made in contemporary major treatment guidelines. The majority of study participants demonstrated some clinical and functional improvements, but not all achieved remission of symptoms or syndrome.

Figure 1

Participant Disposition.¹ One participant withdrew consent after the first study visit; study entry results n = 239, post-study entry n = 238 (unless otherwise stated). ² Two participants died due to natural causes, one from suicide.

Figure 2

Proportion of Participants Experiencing Symptomatic¹ or Syndromal² Remission or Relapse into Mania or Depression. These are unadjusted data based on predominant treatment. Refer to Methods for the definitions of symptomatic relapse, symptomatic remission, syndromal relapse and syndromal remission for mania and depression. Groups were defined based on predominant treatment (PT; based on DDD units). PT-olanzapine refers to those participants (n = 57) in which olanzapine had the highest DDD unit value. PT-CMS refers to those participants (n = 121) in which a CMS had the highest DDD unit value. ¹Symptomatic remission: from a manic state is defined as a YMRS total score of ≤12 and HAMD₂₁ ≤8; from a depressive state is defined as a HAMD₂₁ total score of ≤8. Symptomatic relapse: to a manic state, is based on a YMRS total score of ≥15 after having met the criteria for symptomatic remission (mania); to a depressed state is based on a HAMD₂₁ total score of ≥15 after having met the criterion for symptomatic remission (depression). ²Syndromal remission: from a manic state is defined as all DSM-IV-TR ‘A’ and ‘B’ criteria for current manic episode are no worse than mild (≤3 on a 1 to 7 scale), and no more than two ‘B’ criteria are mild (=3 on a 1–7 scale); from a depressive state is defined as all DSM-IV-TR ‘A’ criteria for current major depressive episode are no worse than mild (≤3 on a 1–7 scale), and no more than three ‘A’ criteria are mild (=3 on a 1–7 scale). Syndromal relapse: to a manic state is based on meeting DSM-IV-TR criteria for current manic episode after having met the criteria for syndromal remission (mania); to a depressed state is based on meeting DSM-IV-TR criteria for current depressive episode after having met the criteria for syndromal remission (depression).

Figure 3

Patterns of Psychotropic Medications¹ Taken at First Visit.¹ Psychotropic medications included are: atypical antipsychotics (AA), antidepressants (AD), benzodiazepines (B), mood stabilizers (MS; olanzapine, lithium, valporate, and carbemazepine), and other (i.e., anticonvulsants, anticholinergics, anxiolytics, and hypnotics).

Figure 4

Treatment Patterns: Total Number of Psychotropic Medications¹ Taken During the Study.¹ Psychotropic medications included are: antipsychotics, antidepressants, benzodiazepines, mood stabilizers (olanzapine, lithium, valporate, and carbemazepine), anticonvulsants (lamotrigine), anticholinergics, anxiolytics, and hypnotics.

Figure 5

Mental and Physical Health Assessment at Each Visit During the 24-Month Study. Mental and Physical health were assessed using the Short-Form Health Survey (SF-36). ¹ Population norm as provided by the SF-36 organization http://www.sf-36.org/tools/SF36.shtml.