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Table_1

Data Management and Analysis

Cyberonics conducted routine clinical monitoring visits at all sites. Data were entered, verified, and analyzed using procedures that ensured the quality of the data and resuits. Response was defined a priori as a 50% reduction at exit in the mean HDRS score obtained at the two baseline (preimplantation) visits (or, for se analyses, a 50% reduction in baseline MADRS or a CGI-1 score of 1 or 2).

Results

Enrollment

A total of 38 patients were enrolled, 30 of whom had implants (Dallas, 14; Charleston, 7; Houston, 6; New York, 3). Of the eight who enrolled but did not have implants, four withdrew consent, one responded to changed medications, and three no longer met the inclu sion/exclusion criteria. This report summarizes findings for the 30 patients with implants, all of whom completed the acute study, and the available postacute study (long term follow-up) outcomes.

Sample Features

Table 1 presents the clinical and demographic features of the sample. The patient population was 67% female. Most (70%) had MDD, and nearly 50% of those with MDD had recurrent MDD. The median Iength of the current MDE was 4.7 years. Over two thirds (70%) of the patients had been in the current MDE for 2 years.

During the fixed-dose stimulation period, parameter settings were confirmed by interrogating the pulse generator at each visit. Adverse events and concomitant medications were coded using the Coding Symbols for Thesaurus of Adverse Reaction Terms (1995) and World Health Organization Drug Dictionarv (1999), respectively. Holter monitoring data for at least 12 hours were collected at baseline (between baseline visits 1 and 2) and at the end of acute study (12 weeks postimplantation).