Sustained Response to Open-Label Venlafaxine in Drug-Resistant Major Depression

Abstract

The aim of this study was to evaluate the response to venlafaxine in patients with treatment-resistant depression during an extension phase of an open-label study of venlafaxine. After completing the initial 8 weeks of the study, patients could continue venlafaxine treatment for an additional period of up to 10 months. Efficacy results are given for 149 patients with treatment-resistant depression. Response was defined as a 50% reduction in scores on the Montgomery-Asberg Depression Rating Scale (MADRS); 69% were responders after 8 weeks of treatment in the initial study phase, and 73% were responders at their final extension-phase visit. The mean MADRS score was 32.8 before treatment, 12.9 by 8 weeks, and 10.8 at the final extension visit. There was a statistically significant reduction of 2.1 MADRS units from entry into the extension phase to the final extension visit. At extension entry, 36.7% patients were in remission, as defined by a MADRS score of less than 12, whereas at the final extension visit, this had increased to 49%. Improvement in Clinical Global Impressions Scale scores (both patient and physician ratings) was maintained throughout the extension period, with 88% of patients reporting some improvement (75% with "very much" or "much") and 92% of doctors noting some improvement in patients (79% with "very much" or "much") at the last extension visit. The safety profile during the extension phase of the study was similar to that found in the initial phase and in other studies. The most common study events were somnolence (21%), headache (18%), insomnia (16%), sweating (16%), constipation (14%), dry mouth (11%), nausea (10%), and dizziness (10%). Patients with resistant depression that was treated with venlafaxine maintained their response for up to 10 months after an 8-week phase of treatment and showed some evidence of further improvement.

Hippocampal volume and antidepressant response in geriatric depression

“…This study aimed to examine remission based on a categorical MADRS score less than ten. Other studies have used MADRS scores ranging from less than 9 to less than 12 to define remission (Forlenza et al, 2001;Schweitzer et al, 2001). Thus, the cut-off of less than 10 in the present study seems reasonable.…”

A randomized, double-blind comparison of olanzapine/fluoxetine combination, olanzapine, fluoxetine, and venlafaxine in treatment-resistant depression

“…Open-label studies of venlafaxine for TRD have typically shown a response in approximately half of patients [De Montigny et al, 1999;Kaplan, 2002;Schweitzer et al, 2001]. In one randomized, double-blind trial of venlafaxine for TRD, the reported response rate [Z50% decrease from baseline in the 17-item Hamilton Depression Rating Scale and Clinical Global Impression (CGI) Improvement score of 1 or 2] was 45%, and the remission rate (Hamilton Depression Rating Scale score o10 on day 28) was 37% [Poirier and Boyer, 1999].…”

Treatment of Major Depressive Disorder in Patients Failing Initial Therapy: An Excel-Based Pharmacoeconomic Model

“…Studies have shown that SSRIs and SNRIs are effective for MDD when patients remain on therapy at the minimum recommended dose and duration of time set forth in clinical practice guidelines (at least 4-9 continuous months). [18][19][20] Although many antidepressants have similar efficacy as first-line agents, few studies have compared them as second-line treatments following initial treatment failure. 21 …”

“…33 nn Managed Care Strategies to Improve Depression Treatment Outcomes When depressed patients maintain continuous therapy for the recommended treatment duration, health care resource costs are reduced compared with patients who discontinue therapy early. 20,34 It then follows that overall costs should decrease when patient compliance is improved and agents associated with a reduced incidence of early discontinuation and therapy change are utilized early in the treatment program. 35 Managed care organizations (MCOs) are challenged to identify optimal, cost-effective strategies for the treatment of depression and improve patient adherence to antidepressant therapy.…”

“…15,17 Consensus has suggested that values of 7o rl ess on the HAM-D arei ndicative of clinical remission. 18,19 For the MADRS instrument, cut-offv alues of 9o rl ess have been found to be approximately 1s tandardd eviation from the mean of nondepressed patients, 20 with various other cut-offv alues (9-12) having been used. 21 Consequently,many clinicians have come to accept that values of 10 or less arelikely to indicate remission.…”