Drug and Alcohol Rehabilitation: Durability of Improvement in Posttraumatic Stress Disorder Symptoms and Absence of Harmful Effects or Drug Dependency After 3,4-Methylenedioxymethamphetamine-Assisted Psychotherapy: A Prospective Long-Term Follow-Up Study.

Durability of improvement in posttraumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study.

Filed under: Drug and Alcohol Rehabilitation

J Psychopharmacol. 2012 Nov 20;
Mithoefer MC, Wagner MT, Mithoefer AT, Jerome L, Martin SF, Yazar-Klosinski B, Michel Y, Brewerton TD, Doblin R

We report follow-up data evaluating the long-term outcomes for the first completed trial of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for chronic, treatment-resistant post-traumatic stress disorder (PTSD) (Mithoefer et al., 2011). All of the 19 subjects who received MDMA-assisted treatment in the original trial participated in the long-term follow-up (LTFU), with 16 out of 19 completing all of the long-term outcome measures, which were administered from 17 to 74 months after the original study’s final MDMA session (mean = 45.4; SD = 17.3). Our primary outcome measure used was the Clinician-Administered PTSD Scale (CAPS). Secondary outcome measures were the Impact of Events Scale-Revised (IES-R) and the Neuroticism Extroversion Oppenness Personality Inventory-Revised (NEO PI-R) Personality Inventory. We also collected a long-term follow-up questionnaire. Results for the 16 CAPS completers showed there were no statistical differences between mean CAPS score at LTFU (mean = 23.7; SD = 22.8) (t(matched) = 0.1; df = 15, p = 0.91) and the mean CAPS score previously obtained at Study Exit (mean = 24.6, SD = 18.6). On average, subjects maintained statistically and clinically-significant gains in symptom relief, although two of these subjects did relapse. It was promising that we found the majority of these subjects with previously severe PTSD who were unresponsive to existing treatments had symptomatic relief provided by MDMA-assisted psychotherapy that persisted over time, with no subjects reporting harm from participation in the study.
HubMed – drug

The Hamilton Rating Scale for Depression: The making of a “gold standard” and the unmaking of a chronic illness, 1960-1980.

Filed under: Drug and Alcohol Rehabilitation

Chronic Illn. 2012 Nov 21;
Worboys M

OBJECTIVES: To show why and how the Hamilton Rating Scale for Depression became the ‘Gold Standard’ for assessing therapies from the mid-1960s and how it was used to frame depression as a short-term and curable illness rather than a chronic one. METHODS: My approach is that of the social construction of knowledge, identifying the interests, institutional contexts and practices that produce knowledge claims and then mapping the social processes of their circulation, validation and acceptance. RESULTS: The circulation and validation of Hamilton Rating Scale for Depression was relatively slow and it became a ‘Gold Standard’ ‘from below’, from an emerging consensus amongst psychiatrists undertaking clinical trials for depression, which from the 1960s were principally with psychopharmaceuticals for short-term illness. Hamilton Rating Scale for Depression, drug trials and the construction of depression as non-chronic were mutually constituted. DISCUSSION: Hamilton Rating Scale for Depression framed depression and its sufferers in new ways, leading psychiatrists to understand illness as a treatable episode, rather than a life course condition. As such, Hamilton Rating Scale for Depression served the interests of psychiatrists and psychiatry in its new era of drug therapy outside the mental hospital. However, Hamilton Rating Scale for Depression was a strange kind of’standard’, being quite non-standard in the widely varying ways it was used and the meanings given to its findings.
HubMed – drug

Tumor Burden Modeling versus Progression-Free Survival for Phase II Decision Making.

Filed under: Drug and Alcohol Rehabilitation

Clin Cancer Res. 2012 Nov 21;
Kaiser LD

Randomized Phase II oncology trial endpoints for decision making include both progression-free survival (PFS) and change in tumor burden as measured by the sum of longest diameters (SLD) of the target lesions. In addition to observed SLD changes, tumor shrinkage and growth parameters can be estimated from the patient-specific SLD profile over time. The ability of these SLD analyses to identify an active drug is contrasted with that of a PFS analysis through the simulation of Phase II trials via re-sampling from each of six large, Phase II and III trials, five of which were positive and one negative. From each simulated Phase II trial, a p-value was obtained from four analyses-a log-rank test on PFS, a Wilcoxon rank-sum test on the minimum observed percentage change from baseline in SLD, and two non-linear, mixed-effects model analyses of the SLD profiles. All four analyses led to approximately uniformly distributed p-values in the negative trial. The PFS analysis was the best or nearly the best analysis in the other five trials. In only one of the positive studies did the modeling analysis outperform the analysis of the minimum SLD. In conclusion, for the decision to start a Phase III trial based on the results of a randomized Phase II trial of an oncology drug, PFS appears to be a better endpoint than does SLD, whether analyzed through simple SLD endpoints, such as the minimum percentage change from baseline, or through the modeling of the SLD time course to estimate tumor dynamics.
HubMed – drug

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