Objective Patients with bipolar disorder suffer from significant cognitive impairment which contributes directly to functional disability in bipolar patients, yet few studies have targeted these symptoms for treatment and the optimal study design remains unclear. We evaluated the effects of the dopamine D2/D3 receptor agonist, pramipexole, on cognition in bipolar disorder. Methods 50 DSM-IV stable bipolar I outpatients enrolled in an 8-week, double-blind, randomized, placebo-controlled cognitive enhancement trial. Patients completed neurocognitive testing at baseline and at week 8. Symptoms and side effects were monitored weekly. Results Forty-five patients completed the study [Placebo (n=24); Pramipexole (n=21)] and groups were well-matched on demographic and clinical features. Primary cognitive analyses were negative; however, secondary analyses revealed some interesting results which serve to highlight several important methodological issues. Subsyndromal mood symptoms at baseline had a significant influence on the degree of improvement due to active drug, with strictly euthymic patients faring best. In addition, the degree of baseline cognitive impairment was also an important factor in treatment response. Conclusions Although largely interpreted as a negative cognitive enhancement trial, our data suggest a potentially beneficial effect of pramipexole on some aspects of cognition in a subgroup patients with bipolar disorder. These data highlight the importance of rigorous subject selection for cognitive trials in bipolar illness. Future studies will be necessary to determine the possible clinical and functional implications of these results. This trial was registered at http://www.clinicaltrials.gov/ with the identifier: NCT00597896.
Objective We conducted a retrospective investigation of potential clinical, demographic, and neuropsychological risk factors for suicide attempts in patients diagnosed with bipolar disorder. Method Participants included 67 adult inpatients and outpatients aged 18–60 years meeting DSM-IV criteria for bipolar disorder (bipolar I and II disorders, bipolar disorder not otherwise specified). We assessed demographic factors, mood symptoms, psychosis, trauma history, trait impulsivity, trait aggression, and reasons for living. The primary outcome measures were the Barratt Impulsiveness Scale-version II, Aggression Questionnaire, and 10 cognitive outcome variables. The cognitive outcome variables assessed cognitive performance across several domains, including processing speed, attention, verbal learning, and executive function. Another aspect of cognitive function, decision making, was assessed using the Iowa Gambling Task. The study was conducted from July 2007–July 2009. Results We found that nonattempters reported significantly higher trait impulsivity scores on the Barratt Impulsiveness Scale compared to attempters (t57 = 2.2, P = .03) and that, among attempters, lower trait impulsivity score was associated with higher scores of lethality of prior attempts (r25 = −0.53, P = .01). Analyses revealed no other group differences on demographic, clinical, or neurocognitive variables when comparing attempters versus nonattempters. Regression models failed to identify any significant predictors of past suicide attempt. Conclusions The largely negative results of our study are particularly important in highlighting the clinical dilemma faced by many clinicians when trying to predict which patients will make serious suicide attempts and which patients are at a lower risk for acting on suicidal thoughts. A limitation of our work is that we examined stable trait measures of impulsivity among a euthymic sample rather than mood state or the impact of mood state on traits. Overall, we conclude that suicidal behavior is extremely difficult to predict, even when comprehensive clinical and neurocognitive information is available.
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