Clinical features associated with poor pharmacologic adherence in bipolar disorder: results from the STEP-BD study.

Background: Poor medication adherence is common among bipolar patients.

Method: We examined prospective data from 2 cohorts of individuals from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study (1999-2005) with bipolar disorder. Clinical and sociodemographic features associated with missing at least 25% of doses of at least 1 medication were assessed using logistic regression, and a risk stratification model was developed and validated.

Deficits in psychological well-being and quality-of-life in minor depression: implications for DSM-V.

Objective: To examine deficits in psychological well-being (PWB) and quality-of-life (QOL) in minor depressive disorder (Min D).

Method: Ninety-three subjects entering a treatment study for Min D were assessed using the QOL, Enjoyment and satisfaction questionnaire (Q-LES-Q), and the Psychological Well-Being Scale (PWBS). Scores were compared with major depressive disorder (MDD) and normative community samples.

Genetic association study of treatment response with olanzapine/fluoxetine combination or lamotrigine in bipolar I depression.

Objective: To evaluate common genetic variations for association with symptomatic improvement in bipolar I depression following treatment with olanzapine/fluoxetine combination (OFC) or lamotrigine.

Method: Symptom improvement was assessed in 88 OFC-treated and 85 lamotrigine-treated white patients with bipolar I depression in the 7-week acute period of a randomized, double-blind study comparing OFC (6/25, 6/50, 12/25, or 12/50 mg/d [olanzapine/fluoxetine]) with lamotrigine (titrated to 200 mg/d). The original study was conducted from November 2003 to August 2004.

Stability of symptoms across major depressive episodes in bipolar disorder.

Objective: Some studies suggest that depressive subtypes, defined by groups of symptoms, have predictive or diagnostic utility. These studies make the implicit assumption of stability of symptoms across episodes in mood disorders, which has rarely been investigated.

Methods: We examined prospective data from a cohort of 3,750 individuals with bipolar I or II disorder participating in the Systematic Treatment Enhancement Program for Bipolar Disorder study, selecting a subset of individuals who experienced two depressive episodes during up to two years of follow-up.

Galantamine-ER for cognitive dysfunction in bipolar disorder and correlation with hippocampal neuronal viability: a proof-of-concept study.

Background: Many subjects with bipolar disorder experience significant cognitive dysfunction, even when euthymic, but few studies assess biological correlates of or treatment strategies for cognitive dysfunction.

Method: Nineteen subjects with bipolar disorder in remission, who reported subjective cognitive deficits, were treated with open-label galantamine-ER 8-24 mg/day for 4 months. Ten healthy volunteers matched for age and gender were also assessed.

What have we learned about bipolar disorder from STEP-BD and other practical trials?

Certain developments are informing the treatment of patients with bipolar disorder. Results from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study and other pragmatic clinical trials are providing practical information on relapse/recurrence, comorbidities, and pharmacologic and psychosocial treatment. Also, the Bipolar Trials Network (BTN) has been established to provide an infrastructure for National Institutes of Health (NIH) and trials with high public health significance.

Diagnosing and treating patients with symptoms of depression.

Because patients with bipolar disorder spend more time experiencing depression than mania, bipolar disorder may be incorrectly diagnosed as unipolar depression. Patients presenting with depressive symptoms should be evaluated for present and lifetime mania symptomatology to ensure a correct diagnosis. Once a bipolar disorder diagnosis has been made, appropriate treatment choices, including mood stabilizers, antipsychotics, psychotherapy, and, in some cases, adjunctive antidepressants, can be made.

Psychosocial interventions as adjunctive therapy for bipolar disorder.

Evidence suggests that adjunctive psychosocial interventions in bipolar disorder are clinically beneficial and cost effective when used in conjunction with pharmacotherapy. Appropriate adjunctive psychosocial interventions in bipolar disorder have been found to be associated with improved treatment adherence, greater stability, fewer hospitalizations, fewer days hospitalized, less need for crisis interventions, decreased relapse risk, and fewer acute episodes. Specific types of therapy that have shown efficacy include bipolar-specific cognitive-behavioral therapy, family-focused therapy, interpersonal and social rhythm therapy, and systematic care management.

Correlates of subjective and objective burden among caregivers of patients with bipolar disorder.

Objective: We examined the relationship between mood symptoms and episodes in patients with bipolar disorder and burden reported by their primary caregivers.

Method: Data on subjective and objective burden reported by 500 primary caregivers for 500 patients with bipolar disorder participating in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) were collected using semistructured interviews. Patient data were collected prospectively over 1 year.

Effectiveness of adjunctive antidepressant treatment for bipolar depression.

Background: Episodes of depression are the most frequent cause of disability among patients with bipolar disorder. The effectiveness and safety of standard antidepressant agents for depressive episodes associated with bipolar disorder (bipolar depression) have not been well studied. Our study was designed to determine whether adjunctive antidepressant therapy reduces symptoms of bipolar depression without increasing the risk of mania.

Psychosocial strategies to improve concordance and adherence in bipolar disorder.

Half of patients with bipolar disorder may exhibit poor medication compliance, and relapse often occurs even when patients take their medication as prescribed. Psychosocial strategies can help patients to recognize the need for treatment and, therefore, improve medication adherence. Another benefit of psychosocial strategies is that they aid patients in controlling their moods.

Childhood antecedent disorders to bipolar disorder in adults: a controlled study.

Objective: The aim of the study was to examine antecedent childhood psychiatric disorders in adult patients with bipolar disorder.

Method: Using structured diagnostic interviews, childhood psychiatric diagnoses of 83 referred patients with diagnosed DSM-IV bipolar disorder were compared to those of 308 adults without mood disorders.

Results: Patients with bipolar disorder had significantly higher rates of childhood disruptive behavior disorders (ADHD, oppositional-defiant disorder, and conduct disorder), childhood anxiety disorders (separation anxiety and overanxious disorder), and enuresis, compared to patients without mood disorders.

The integration of measurement and management for the treatment of bipolar disorder: a STEP-BD model of collaborative care in psychiatry.

Patients with bipolar disorder are among the most challenging to treat. These patients frequently present with complex mood and other symptoms that change over time, complex psychiatric and medical comorbid conditions, and multiple medications. Clinicians rarely systematically assess or measure all of these factors and instead rely on memory and general impressions.

Treatment-resistant bipolar depression: a STEP-BD equipoise randomized effectiveness trial of antidepressant augmentation with lamotrigine, inositol, or risperidone.

Objective: Clinicians have few evidence-based options for the management of treatment-resistant bipolar depression. This study represents the first randomized trial of competing options for treatment-resistant bipolar depression and assesses the effectiveness and safety of antidepressant augmentation with lamotrigine, inositol, and risperidone.

Method: Participants (N=66) were patients with bipolar I or bipolar II disorder enrolled in the NIMH Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD).

Current management of bipolar affective disorder: is it reflective of the BAP guidelines?

In October 2003 the British Association of Psychopharmacology (BAP) published evidence-based guidelines on the management of bipolar disorder. The aim of this study was to assess whether the guidelines could provide the basis for examining clinical decisions and the extent to which practice accords with these guidelines. Case notes of out patients with bipolar disorder were reviewed.

The role of pharmacologic treatment guidelines for bipolar disorder.

With the growth in the number of pharmacologic options available for the treatment of bipolar disorder, clinicians face a challenge in appropriately selecting and sequencing newer and older treatments. Because evidence-based practice has been suggested as a way to improve outcomes across specialties in medicine, a number of practice guidelines and treatment algorithms for bipolar disorder have been developed to aid clinical decision-making. Most of these guidelines and algorithms are based on detailed reviews of the medical literature, with an emphasis on systematic reviews and randomized, controlled trials.

Strategies for improving treatment of bipolar disorder: integration of measurement and management.

Objective: Bipolar disorder is a common and complex condition associated with high rates of disability and high health care costs. The aim of this article is to provide an overview of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD).

Method: The Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) was conceived in response to an NIMH request for proposals to study the effectiveness of treatments for Bipolar Disorder.

Administration of antidepressants. Single versus split dosing: a meta-analysis.

Objective: To evaluate the literature comparing antidepressant effects of multiple daily dosing versus single daily dosing of antidepressants.

Method: Studies comparing efficacy of single versus multiple daily dosing of antidepressants were reviewed. Data from the clinical trials meeting our inclusion criteria was subgrouped according to the half-life of the antidepressant drug studied.