We previously described the existence of two quantitative EEG (QEEG) subtypes of cocaine dependent males, identified at baseline, displaying differential proneness to relapse. The current study expands the population to include females and enhances the measure set to include both QEEG and somatosensory EP (SEP) features. Fifty-seven cocaine dependent adults (16 F, 41 M) were evaluated 5-14 days after last cocaine use, while in residence at a drug-free therapeutic community. The median length of stay in treatment (continued abstinence) was 25 weeks. Using a small subset of QEEG and SEP baseline features, three subtypes (CLUS) were identified. CLUS 2 (n = 25) and CLUS 3 (n = 23) replicated the published subtypes, while CLUS 1 (n = 9) was previously undescribed. Cluster membership was significantly associated with length of stay in treatment (chi 2 = 13.789, P < 0.001), but not with length of exposure to crack cocaine or to any demographic or clinical features. Seventy-eight percent of CLUS 1 and 65% of CLUS 3 left treatment < or = 25 weeks, whereas 80% of CLUS 2 remained in treatment > 25 weeks. The existence of outcome related subtypes may reflect: [1] differential neurophysiological vulnerability, "traits," predisposing individuals to cocaine addiction; or [2] differential neurosensitivity, "states," due to the effects of chronic cocaine exposure, and associated differences in treatment outcome. Using Variable Resolution Electrical Tomographic Analysis (VARETA), the mathematically most probable neuroanatomical source of the scalp recorded EEG data was localized. Computation of VARETA on the baseline Cluster profiles suggest significant differences in the underlying pathophysiology of these subtypes.
A National Institutes of Health (NIH) expert panel has mentioned a daily methadone dose of at least 60 mg as a best practice in methadone maintenance. The focus of this research is to estimate the percentage of outpatient methadone clients receiving this level of methadone and examine the association between treatment retention and level of methadone dosage as recommended by the NIH expert panel. A sample of 428 methadone clients discharged from methadone treatment facilities from the Alcohol and Drug Services Study (ADSS) was used, representing 109,973 methadone clients nationally. It was estimated that more than two-thirds of methadone clients nationally were receiving below 60 mg/day. While controlling for a number of client and organizational variables, a daily methadone dose of 60 mg/day or above was found to be associated with longer retention in treatment. Exploring factors affecting the utilization of the recommended daily methadone dose remains an important issue in effective delivery of methadone treatment.
This study was designed to determine the safety, efficacy and pharmacokinetics of the antidepressant netamiftide (previously designated name: INN 00835) after 5 or 10 daily doses administered to patients diagnosed with major depression. Netamiftide was administered subcutaneously at a fixed dose of 18 mg/patient per day. Of the 55 enrolled patients, 22 were dosed for 10 days with drug, 11 for 5 days with drug followed by 5 days with placebo and 22 for 10 days with placebo only. The effect of treatment with netamiftide was evaluated by the following psychometric tests: Hamilton Depression Rating, Montgomery-Asberg Depression Rating Scale, Carroll Self-Rating Depression and Clinical Global Impression scales. None of the patients experienced significant adverse effects. A pharmacodynamic correlation (P < 0.05) was found between plasma drug concentrations and response to treatment. Highest plasma concentrations (Cmax) of netamiftide averaging 45.7 ng/ml were observed at 0.25 h after dosing. There were 89% responders in the group with Cmax > or = 45.7 ng/ml (minimum therapeutic concentration) versus 40% in the group with Cmax < 45.7 ng/ml. Onset of action was observed within 48 h after treatment, peak effect was observed at approximately 1 week after treatment and efficacy lasted during a 4-week follow-up period. Netamiftide is a promising antidepressant with rapid onset of action and with an excellent safety profile.
Nemifitide is a novel pentapeptide antidepressant, which appears to be effective in the treatment of major depressive disorder (MDD). In the present study 81 patients with MDD, DSM-IV criteria were randomized following a 1-wk screening period to receive 30 mg/d nemifitide, 45 mg/d nemifitide or placebo in a 6-wk double-blind, multicentre, outpatient efficacy study. Nemifitide or placebo was delivered by subcutaneous injection for 2 wk daily for 5 days (Monday to Friday) in the first 2 wk and patients were followed up for a further 4 wk. The primary efficacy measure was the change from baseline on the Montgomery-Asberg Depression Rating Scale. Secondary measures included the 17-item Hamilton Psychiatric Rating Scale for Depression (HAMD), the CGI severity and improvement scale and the Carroll Self-Rating Scale for Depression. This proof-of-principle study demonstrated a statistically significant superiority of the 45-mg/d dose vs. placebo at the time-point of peak effect (1 wk after the end of treatment). There appeared to be a greater effect with the 45 mg/d nemifitide dose than with 30 mg/d. An additional exploratory analysis by stratification of all patients by severity above and below or equal to the median baseline HAMD score of 22 showed a higher percentage of responders for both doses of nemifitide with statistical separation from placebo for patients with baseline HAMD score of >22 (above the median). There was no significant difference among treatment groups for patients with baseline HAMD score of
Cluster analysis was used to evaluate the data from a placebo-controlled, double-blind clinical trial with a new pentapeptide antidepressant (INN 00835) in major depression. The objective of this paper is to examine the effect of separating the study population into homogeneous subgroups (clusters) with relatively similar response to treatment within subgroups, and significantly different response between subgroups. The list of variables for cluster analysis was selected only from the efficacy parameters investigated in the study. Three to six clusters were modelled to obtain the optimal number of clusters, based on a proportional contribution of subjects per cluster, and the maximum statistical difference between clusters. After separation, the variability of response among drug-treated subjects by cluster was attributed to plasma drug concentration. Platelet serotonin uptake, which is a putative biochemical marker of effective treatment of depression, also reproduced the same effect of separation as the initially established cluster variables.
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