Combination Pharmacotherapy and Psychotherapy for the Treatment of Major Depressive and Anxiety Disorders

Aaronson, Cindy J.; Katzman, Gary; Moster, Rachel

doi:10.1093/med:psych/9780199342211.003.0016

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“…However, it is crucial to acknowledge the significant limitations of this study . The sample was small (N = 15), the diagnoses limited to bipolar II, and the illness severity in the moderate range.…”

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“…In this context, Aaronson and colleagues present an important step forward in this single-arm open-label study of psilocybin in patients with bipolar II depression. In this study, 15 participants with bipolar II depression (mean [SD] duration, 2.5 [2.3] years) had their psychotropic medication tapered off and were given a high dose (25 mg) of psilocybin with psychological support before, during, and after the dose.…”

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“…Aaronson and colleagues are transparent about the design of the study and its limitations—but the limitations are still important to emphasize, given the cultural zeitgeist surrounding the potential of psychedelics. There are a number of influential commentators on the field of psychedelics without medical or scientific training, who have a tendency to seize on particular findings with either extreme fear or enthusiasm.…”

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Psilocybin in Bipolar II Study Provides Preliminary Data on Safety

Yaden,

Gukasyan,

Nayak

2024

JAMA Psychiatry

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Bipolar II disorder is a chronic condition characterized by episodes of depression and hypomania and is associated with increased morbidity and mortality. 1 For most patients, depressive episodes predominate the course of illness and can be more difficult to treat than unipolar depression. The use of serotonergic antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), is controversial due to an elevated risk of precipitating manic episodes and mood cycling. 1 Despite the need for more and better interventions, innovation has been limited.Meanwhile, a growing body of data suggests therapeutic potential for psilocybin in unipolar depression. Several randomized clinical trials have shown benefits for major depressive disorder, 2-4 including treatment-resistant unipolar depression. 5 A trial comparing psilocybin with active treatment with an SSRI yielded equivocal results nonsignificantly favoring psilocybin. 6 While it seems logical that this antidepressant potential might extend to bipolar depression, most psilocybin studies conducted in the past 2 decades have excluded individuals with a personal or family history of bipolar disorders from participating in trials. 7 This has largely been done out of reasonable caution due to clinical experience and anecdotal reports of psychedelics resulting in manic episodes in uncontrolled contexts. Yet empirical evidence regarding this risk has been limited. A survey study of participants with bipolar spectrum disorders, including those with bipolar I, found that 14% of the sample reported that taking a psychedelic in recreational settings triggered manic symptoms, although most reported benefits from these experiences. 8 In this context, Aaronson and colleagues 9 present an important step forward in this single-arm open-label study of psilocybin in patients with bipolar II depression. In this study, 15 participants with bipolar II depression (mean [SD] duration, 2.5 [2.3] years) had their psychotropic medication tapered off and were given a high dose (25 mg) of psilocybin with psychological support before, during, and after the dose. At 3 weeks, all participants had lower Montgomery-Åsberg Depression Rating scale scores, with a mean (SD) change of 24.0 (9.2) points and 12 (80%) meeting criteria for response and 11 (73%) for remission. This benefit appeared to endure: at 12 weeks, 12 participants (80%) met criteria for both response and remission. Most importantly, there were no significant adverse events, and Young Mania Rating Scale scores were unchanged before to after psilocybin treatment.The results of this trial are relevant for both efficacy and safety. However, the evidence for safety is far more compelling. Contrary to this study's findings, we suspect that most clinicians and researchers would have guessed that 1 or more Related article page 555 Opinion EDITORIAL jamapsychiatry.com (Reprinted) JAMA

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