«Psychedelics, OCD and Related Disorders: Setting Methodological Strategies for Future Studies»

Journal of Obsessive-Compulsive and Related Disorders, Год журнала: 2025, Номер unknown, С. 100951 - 100951

Опубликована: Март 1, 2025

Язык: Английский

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From Efficacy to Effectiveness: Evaluating Psychedelic Randomized Controlled Trials for Trustworthy Evidence‐Based Policy and Practice

Pharmacology Research & Perspectives, Год журнала: 2025, Номер 13(2)

Опубликована: Апрель 1, 2025

ABSTRACT The recent review of a new drug application for MDMA‐assisted therapy posttraumatic stress disorder by the United States' Food and Drug Administration (FDA) highlighted epistemological methodological challenges evidence assessments. Similar will also be faced in reviews other compounds early‐ late‐stage development, like psilocybin depression. regulatory demand two successful phase 3 randomized controlled trials (RCTs) seems problematic, given current lack agreement on what constitutes “success”, particularly when psychoactive administration is concomitant with (psycho)therapy. These complex arrangements challenge internal validity estimated average treatment effect through comparison conventional control conditions. This paper assumptions behind RCTs' “gold‐standard” status hierarchy evidence‐based medicine (EBM). Recapitulating known epistemic limits randomization blinding, it emphasizes urgent need to avoid extrapolation fallacy. resulting argument that degree trustworthiness efficacy—reported RCTs—will reliably predict effectiveness—in target populations outside RCTs—depends type psychedelic treatments regulated. If “stand‐alone” drugs large‐scale prescription consumption, should graded low. On hand, regulation drug‐assisted (psycho) therapies, can considered high. reason being these approaches are based different causal claims distinct external validities. Therefore, careful assessment support factors each recommended prevent detrimental consequences, from potential rejection effective therapies up medical reversal eventually approved drugs.

Язык: Английский

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Psilocybin-assisted psychotherapy as a rapid-acting treatment for cancer-related depression and anxiety: Evidence from a network meta-analysis

The International Journal of Psychiatry in Medicine, Год журнала: 2025, Номер unknown

Опубликована: Апрель 25, 2025

Objective To evaluate psilocybin’s efficacy in reducing depressive and anxiety symptoms cancer patients based on randomized controlled trials (RCTs). Methods This systematic review network meta-analysis (NMA) followed PRISMA Cochrane Handbook guidelines. PubMed, Embase Library data up to July 2024 were analyzed. Two RCTs met the inclusion criteria. Changes Beck Depression Inventory (BDI) State-Trait Anxiety (STAI) scores assessed day 1 2-week follow-up. The risk of bias was evaluated with Risk Bias Tool 2.0. Results Psilocybin significantly reduced BDI at post-administration (MD = −2.26; P 0.01), though effects not sustained 2 weeks. STAI state showed substantial reductions both −11.52; < 0.001) weeks −12.66; 0.001). trait also improved 14. highest psilocybin dose (0.3 mg/kg) most effective, SUCRA values 87.81% (BDI), 91.58% (STAI state), 94.2% trait). Conclusions Findings suggest may rapidly reduce patients, but methodological limitations, including small number trials, necessitate cautious interpretation. Larger, high-quality are needed verify its clinical potential.

Язык: Английский

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Treating posttraumatic stress disorder and alcohol use disorder comorbidity: Current pharmacological therapies and the future of MDMA-integrated psychotherapy

Journal of Psychopharmacology, Год журнала: 2023, Номер 37(12), С. 1182 - 1189

Опубликована: Ноя. 27, 2023

Posttraumatic stress disorder (PTSD) and alcohol use (AUD) frequently co-occur in patients who have experienced trauma. This comorbidity leads to a vicious cycle where PTSD symptoms beget heavy drinking vice versa. There are no FDA-approved medications treat PTSD-AUD; therefore, individuals suffering from this treated with medication approved the disorders separately or off-label pharmacological interventions. However, these limited their efficacy for treating PTSD-AUD comorbidity. Emerging research on nonclassical psychedelic drug 3,4-methylenedioxymethamphetamine (MDMA) suggests that it may be an effective used conjunction psychotherapy. The following reviews current clinical pharmacotherapies, as well MDMA-integrative psychotherapy they pertain AUD isolation co-occurrence. Future directions role of psychedelic-integrative therapy treatment discussed.

Язык: Английский

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Psychedelika und Dissoziativa in der Psychiatrie: Herausforderungen in der Behandlung

Der Nervenarzt, Год журнала: 2024, Номер 95(9), С. 803 - 810

Опубликована: Авг. 28, 2024

With the discovery of antidepressive effects ketamine and increasing withdrawal pharmaceutical industry from development new psychotropic drugs, psychiatric research into clinical application hallucinogens in psychiatry has literally blossomed last two decades. Promising results for various treatment approaches with psychedelic agents, such lysergic acid diethylamide (LSD) psilocybin, dissociative as esketamine, have raised great hopes among researchers, clinicians patients recent years, so that there was already talk a era psychiatry. As one first these substances, December 2019 intranasal esketamine approved USA EU treatment-resistant depression Switzerland followed 2020. Recently, psilocybin Australia, Canada compassionate use exceptional cases depression, while large approval studies agents are currently ongoing worldwide. The medical ketamine/esketamine is considered to be safe; however, all forms it crucial importance that, addition hopes, specific challenges must also carefully assessed. Excessive expectations an insufficient risk-benefit estimation detrimental reputation treating physician. Although possible paradigm shift care mental health being discussed, this review article consciously concentrates on risks methodological weaknesses carried out far.

Язык: Английский

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Randomized Controlled Trials of Psilocybin‐Assisted Therapy in the Treatment of Major Depressive Disorder: Systematic Review and Meta‐Analysis

Acta Psychiatrica Scandinavica, Год журнала: 2024, Номер unknown

Опубликована: Дек. 3, 2024

ABSTRACT Introduction There is growing interest in the use of psychedelic‐assisted therapy (PAT) for major depressive disorder (MDD), including treatment‐resistant depression. We used randomized controlled trial (RCT) data to compare summary estimates change depression ratings with PAT versus comparator treatments MDD. also compared response and remission rates, adverse effects. Methods searched MEDLINE, EMBASE, Cochrane Central Register Controlled Trials (CENTRAL), SCOPUS from inception till April 2024. Our primary efficacy outcome was 1‐week (or nearest) between‐group ratings. Secondary outcomes were changes at days 2, 14, 42 study‐defined rates week 1 nearest). Safety reported pooled random‐effects meta‐analyses using standardized mean difference (SMD; Hedges g ) continuous risk ratio (RR) categorical outcomes. Results found 6 eligible RCTs (pooled N = 427), all on psilocybin. The SMD −0.72 [95% CI, −0.95 −0.49; I 2 17%; 5 RCTs; n 403], favouring PAT; results similar 42. [RR 3.42; 95% 2.35–4.97; 0%; 4 373] 3.66; 2.26–5.92; favored PAT. group had a small but significantly increased developing any event 1.20; 1.01–1.42; 43%; higher experiencing headache 1.78; 1.10–2.86; 52%; dizziness 6.52; 1.19–35.87; 3 269]. Low heterogeneity characterized most analyses findings sensitivity analyses. Conclusion Antidepressant effects psilocybin‐assisted are superior (with least medium effect sizes) interventions up weeks postintervention.

Язык: Английский

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Design and Methodology of the First Open-Label Trial of MDMA-Assisted Therapy for Veterans with Post-Traumatic Stress Disorder and Alcohol Use Disorder: Considerations for a Randomized Controlled Trial

Contemporary Clinical Trials Communications, Год журнала: 2024, Номер 41, С. 101333 - 101333

Опубликована: Июль 20, 2024

Posttraumatic stress disorder and alcohol use (PTSD, AUD) commonly co-occur are associated with more severe symptomatology than either alone, increased risk of suicide, poorer response to existing treatments. A promising therapeutic intervention is the integration 3,4-methylenedioxymethamphetamine (MDMA) psychotherapy. The Federal Drug Administration (FDA) designated MDMA assisted therapy (MDMA-AT) as a Breakthrough Therapy for PTSD based on results from six Phase 2 clinical trials. Case data first study evaluating MDMA-AT AUD found treatment was well tolerated significantly reduced post treatment. This manuscript reports premise, design, methodology open-label trial military veterans (N=12) AUD. Neuroimaging biomarker included evaluate brain changes, neuroinflammation, pre-post component (comorbidity) regulatory processes (Schedule I drug) setting up this long complex. research community will benefit work establish common outcomes, standardized protocols, assessments FDA approval. NCT05943665

Язык: Английский

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What should constitute a control condition in psychedelic drug trials?

Nature Mental Health, Год журнала: 2024, Номер unknown

Опубликована: Сен. 30, 2024

Язык: Английский

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