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PubMed2001

Sustained response to open-label venlafaxine in drug-resistant major depression.

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.

Adult↗
PubMed2001

Anti-Inflammatory effects of antidepressants through suppression of the interferon-gamma/interleukin-10 production ratio.

There is some evidence that major depression--in particular, treatment-resistant depression (TRD)--is accompanied by activation of the inflammatory response system and that proinflammatory cytokines may play a role in the etiology of depression. This study was carried out to examine the effects of antidepressive agents, i.e., imipramine, venlafaxine, L-5-hydroxytryptophan, and fluoxetine on the production of interferon-gamma (IFN-gamma), a proinflammatory cytokine, and interleukin-10 (IL-10), a negative immunoregulatory cytokine. Diluted whole blood of fluoxetine-treated patients with TRD (mean age, 50.6+/-3.9 years) and age-matched healthy controls (mean age, 51.6+/-1.7 years) and younger healthy volunteers (mean age, 35.4+/-9.6 years) was stimulated with phytohemagglutinin (1 microg/mL) and lipopolysaccharide (5 microg/mL) for 48 hours with and without incubation with the antidepressants at 10-6 M and 10(-5) M. IFN-gamma and IL-10 were quantified by means of enzyme-linked immunoassays. The ratio of IFN-gamma to IL-10 production by immunocytes was computed because this ratio is of critical importance in determining the capacity of immunocytes to activate or inhibit monocytic and T-lymphocytic functions. All four antidepressive drugs significantly increased the production of IL-10. Fluoxetine significantly decreased the production of IFN-gamma. All four antidepressants significantly reduced the IFN-gamma/IL-10 ratio. There were no significant differences in the antidepressant-induced changes in IFN-gamma or IL-10 between younger and older healthy volunteers and TRD patients. Tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin-noradrenaline reuptake inhibitors, as well as the immediate precursor of serotonin, have a common, negative immunoregulatory effect by suppressing the IFN-gamma/IL-10 production ratio. It is suggested that the therapeutic efficacy of antidepressants may be related to their negative immunoregulatory effects.

5-Hydroxytryptophan↗
PubMed2001

Mirtazapine versus venlafaxine in hospitalized severely depressed patients with melancholic features.

The aim of this multicenter, randomized, double-blind, 8-week study was to compare the antidepressant efficacy and tolerability of mirtazapine and venlafaxine in the treatment of hospitalized patients with DSM-IV diagnosis of severe depressive episode with melancholic features. Patients with a baseline score of > or = 25 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17) were randomly assigned to receive treatment with either mirtazapine (N = 78, 15-60 mg/day) or venlafaxine (N = 79, 75-375 mg/day, twice a day) in a rapid up-titration schedule. Efficacy was assessed with the Montgomery-Asberg Depression Rating Scale (MADRS), HAM-D-17, and Clinical Global Impression scale, and quality of life was assessed with the Quality of Life, Enjoyment, and Satisfaction Questionnaire and Quality of Life in Depression Scale. Tolerability was assessed with the Utvalg for Kliniske Undersogelser (UKU) side effect scale and by reporting adverse events. Both drugs were effective in reducing overall symptoms of depression, showing substantial reductions in group mean MADRS scores (-20.1 for mirtazapine and -17.5 for venlafaxine) and HAM-D-17 scores (-17.1 for mirtazapine and -14.6 for venlafaxine) at the end of the treatment. Although not statistically significant, at all assessment times higher percentages of patients treated with mirtazapine were classified as responders (> or =50% reduction) on the HAM-D (at endpoint, 62% vs. 52%) and MADRS (at endpoint: 64% vs. 58%). Likewise were the percentages of remitters (HAM-D score < or =7; MADRS score < or =12) also higher in the mirtazapine group. A statistically significant difference favoring mirtazapine was found on the HAM-D Sleep Disturbance factor at all assessment points (p < or = 0.03). Both treatments were well tolerated. Although slightly more subjects treated with mirtazapine reported at least one adverse event, a statistically significantly higher percentage of patients treated with venlafaxine (15.3%) than mirtazapine (5.1%) dropped out because of adverse events (p = 0.037). Quality of life improved in both treatment groups. In this study, treatment with mirtazapine resulted in a trend toward more responders and remitters than treatment with venlafaxine and in significantly fewer dropouts as a result of adverse events.

Adolescent↗
PubMed2002

Effectiveness of venlafaxine, extended release formulation, in the short-term and long-term treatment of generalized anxiety disorder: results of a survival analysis.

A survival analysis of data from two placebo-controlled, randomized, long-term (6-month) studies was used to examine the effectiveness of venlafaxine, extended release (XR) formulation, in patients with generalized anxiety disorder (GAD). Patients in a placebo-controlled, flexible-dose study received 75 to 225 mg/day venlafaxine XR, while patients in a placebo-controlled, fixed-dose study received once-daily venlafaxine XR doses of 37.5 mg, 75 mg, or 150 mg. The survival analysis was based on the clinician's decision to discontinue treatment in a placebo-controlled study and incorporated data from all patients who were randomized. In each study, placebo-treated patients discontinued treatment due to lack of efficacy more frequently and earlier than those receiving venlafaxine XR (p < 0.001, log-rank test). A dose-response relationship was apparent, with the lowest rate of withdrawal seen at the highest venlafaxine XR dose. Survival curves for discontinuations due to adverse events did not differ significantly in either study. These results were consistent with the conventional intent-to-treat efficacy assessments of changes in anxiety severity, highlighting the superiority of venlafaxine XR over placebo in the long-term treatment of GAD. Overall, these results demonstrate the clinical effectiveness of venlafaxine XR in the short-term and long-term treatment of GAD.

Antidepressive Agents, Second-Generation↗
PubMed2003

Single-blind comparison of venlafaxine and nortriptyline in elderly major depression.

The objective of this single-blind study was to compare the efficacy and safety of venlafaxine extended-release and nortriptyline in elderly patients with moderate to severe major depression. In- and out-patients (N=68) with unipolar major depression were randomized to receive 6-month treatment with either nortriptyline or venlafaxine. Outcomes of the two groups were compared using measures including the Hamilton Depression Rating Scale (HDRS) and the Newcastle Scale. Side effects were assessed with the UKU side-effect rating scale. Of the 34 venlafaxine-treated patients, 22 were remitters, 7 were nonremitters, and 5 dropped out. The intent-to-treat remission rate was 71% (22 of 31). Of the 34 who received nortriptyline, 21 were remitters, 7 were nonremitters, and 6 dropped out. The intent-to-treat remission rate was 70% (21 of 30). These results suggest that the remission rate with a therapeutic plasma level of nortriptyline is similar to the remission rate with a standard dose of venlafaxine in this group of elderly major depressed patients. No significant differences were observed between dropout rates in the two groups, but autonomic side-effects were significantly more frequent for nortriptyline than for venlafaxine. These results confirm the efficacy and safety of venlafaxine extended-release for treating elderly major depression.

Aged↗
PubMed1993

Acute effects of the novel antidepressant venlafaxine on cognitive event-related potentials (P300), eye blink rate and mood in young healthy subjects.

Venlafaxine is a novel non-tricyclic antidepressant, which preclinically has demonstrated serotonin, norepinephrine, and dopamine reuptake inhibiting effects. In this study acute effects of single oral doses of placebo, 12.5 mg, 25 mg, and 50 mg venlafaxine on event-related potentials (ERPs), eye blink rate and mood were studied in 16 healthy subjects. ERPs were investigated in an auditory odd-ball paradigm before as well as 3 h after each drug intake. In addition to 17 EEG leads, vertical and horizontal EOGs were recorded. After EOG minimization and visual artefact rejection the peak latencies of the spatial average were determined by an automatic procedure. The applied methods of data acquisition, artefact processing, objective component determination and statistical analysis were successful in describing acute effects of venlafaxine on ERPs in normals. N1 and P2 latencies were not affected. An increase in P2 amplitude in the relevant central and frontal regions was seen, reflecting some effect on automatic information processing. Stimulus evaluation time was not affected, as P300 latency remained unchanged. P300 amplitude was not affected at the relevant central and parietal region. Blink rate was not changed. By means of the adjective checklist a dose-dependent decrease of "extroversion" and "high spirits" and an increase of "introversion" was observed. Our findings suggest that venlafaxine affects human information processing less than would be expected from the more centrally inhibiting classical antidepressants.

Adult↗
PubMed1994

A double-blind comparison of venlafaxine and fluoxetine in patients hospitalized for major depression and melancholia. The Venlafaxine French Inpatient Study Group.

The antidepressant efficacy and short-term safety of venlafaxine and fluoxetine were compared in 68 patients hospitalized with major depression and melancholia. Venlafaxine was superior in efficacy to fluoxetine; total scores for both the MADRS and the HAM-D were significantly (p < or = 0.05) lower in the venlafaxine group than in the fluoxetine group at Weeks 4 and 6. Overall tolerance was similar for the two treatments.

Antidepressive Agents, Second-Generation↗
PubMed1995

Pharmacologic profile and efficacy of venlafaxine.

Venlafaxine is a structurally novel phenylethylamine agent with antidepressant properties. The preclinical profile suggests that it will be as effective as the tricyclic antidepressants (TCAs) with few significant effects on the neuroreceptors that mediate many of the side effects common with the TCAs. Venlafaxine has been studied in more than 2500 patients in clinical trials; its efficacy has been evaluated in more than 700 venlafaxine-treated patients in six placebo-controlled trials (five in out-patients and one in in-patients). These studies used a wide range of doses (25-375 mg/day) and different dose regimens (t.i.d. and b.i.d). The results of these studies clearly establish that venlafaxine is significantly more effective than placebo. In the two studies that used doses of 375 mg/day, a significant difference from placebo was observed on the Montgomery- Asberg Depression Rating Scale (MADRS) at the earliest time points assessed, after 4 days of treatment in the in-patient study and after 1 week of treatment in the out-patient study. Venlafaxine also appears to be as effective as some reference antidepressants. A positive dose-response effect has been demonstrated with doses of up to 375 mg/day, with a minimum effective dose of 75 mg/day.

Animals↗
PubMed1995

Safety and tolerance profile of venlafaxine.

Venlafaxine has been shown in clinical trials to be safe and well tolerated in patients with major depression. Data were pooled from 19 studies in which 2181 patients were given venlafaxine, 451 were given placebo and 591 were given a reference antidepressant (imipramine, trazodone, clomipramine, maprotiline, dothiepin or amineptine). Long-term safety was evaluated in 422 patients who were given venlafaxine for at least 1 year; as well, a total of 229 elderly patients have been treated with venlafaxine, including 66 who were given it for at least 1 year. The adverse events that occurred during short-term treatment in > or = 10% of patients were nausea, headache, insomnia, somnolence, dry mouth, dizziness, constipation, asthenia, sweating and nervousness. In comparator-controlled trials, the frequency of anticholinergic events with the reference agents was approximately twice that with venlafaxine. The safety profile and patient acceptability of venlafaxine are comparable to those of third-generation antidepressants, and possibly better than those of first-generation agents.

Antidepressive Agents, Second-Generation↗
PubMed1995

Rapid onset of action of venlafaxine.

It is important to evaluate a new antidepressant in terms of its efficacy in relation to that of reference agents such as the tricyclics and monoamine oxidase inhibitors. Newer antidepressants have not been shown to be more effective than the reference agents, either in the proportion of patients in whom they produce a therapeutic response or in their speed of onset of antidepressant activity. The serotonin-noradrenaline reuptake inhibitor (SNRI) venlafaxine appears to offer some advantages in both of these areas. In a number of short-term placebo- and comparator-controlled trials, venlafaxine was shown to be as effective as, and in some cases more effective than, the reference antidepressants. These findings were also substantiated in meta-analyses of both short-term and long-term comparator-controlled studies. In terms of its onset of activity, venlafaxine was shown to produce statistically significant differences from placebo as early as Day 4 in a study in severely depressed in-patients with melancholia and by Week 1 in a study in out-patients with major depression. A rationale is presented to define the clinical relevance of these findings.

Antidepressive Agents, Second-Generation↗
PubMed1995

Clinical utility of venlafaxine in comparison with other antidepressants.

The newer antidepressants have clearly shown themselves to be safer and to have a more acceptable side effect profile than the traditional antidepressants. Greater patient acceptability has important consequences in relation to efficacy, in that compliance is likely to be better in the long term. One of the newest antidepressants, the serotonin- noradrenaline reuptake inhibitor venlafaxine, has neurobiologic properties that recommend it for clinical use by both the psychiatrist and the general practitioner. Controlled studies have confirmed the overall utility of this agent in treating a range of depressive subtypes, such as moderate depression and severe endogenous depression, with a low risk of serious adverse events and an excellent tolerability profile. In addition, venlafaxine has shown a dose-response relationship for efficacy, offering the possibility of a wide dose range, which may be suitably employed in different clinical situations.

Antidepressive Agents↗
PubMed1998

Response to venlafaxine in a previously antidepressant treatment-resistant combat veteran with post-traumatic stress disorder.

Post-traumatic stress disorder (PTSD) is frequently treated with antidepressant medications, especially the newer selective serotonergic antidepressants which have documented efficacy in PTSD. Analogous to depression, however, some PTSD patients may not have a satisfactory response to these agents. This case report describes a PTSD patient who did not respond to several serotonergic antidepressants, but did improve with venlafaxine which has both noradrenergic and serotonergic properties.

Antidepressive Agents, Second-Generation↗
PubMed1999

Venlafaxine in social phobia: a study in selective serotonin reuptake inhibitor non-responders.

The study aimed to evaluate the clinical response to venlafaxine in social phobia in 12 patients who were non-responders to selective serotonin reuptake inhibitors, and to assess how the response could be influenced by the comorbidity in Axis II with avoidant personality disorder (APD). The duration of the study was of 15 weeks using open flexible doses regimen in individuals with or without concomitant APD. The venlafaxine dose ranged from 112.5 mg/day to 187.5 mg/day. Venlafaxine improves social phobia and/or APD symptomatology, as demonstrated by decreasing Liebowitz Social Anxiety Scale total scores (P < 0.05). In fact, venlafaxine significantly reduced the avoidant behaviour and specific sociophobic aspects, while notably improving the depression dimension and the basic anxiety symptoms. With regard to tolerability, the profile of venlafaxine was satisfactory with the main side-effects being nausea, headache and anxiety.

Adolescent↗