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PubMed2003

ECT resistance and early relapse: two cases of subsequent response to venlafaxine.

Many depressed patients who fail to respond to numerous trials of antidepressant medications are ultimately referred for electroconvulsive therapy (ECT). However, a complete response does not occur in all depressed patients referred for ECT. The erroneous portrayal of ECT as a 'last ditch' treatment of depression leads to predictable despair if ECT fails or if early relapse occurs after a brief response. Therapeutic nihilism is not warranted in these cases. There is evidence in the literature that patients who fail to respond to adequate trials of antidepressant medications prior to ECT failure or early relapse subsequently respond to psychopharmacological treatment with high doses of venlafaxine. The following two case reports provide examples of depressed patients who subsequently responded to high doses of venlafaxine after demonstrating resistance to ECT, or experiencing rapid relapse after successful ECT.

Antidepressive Agents, Second-Generation↗
PubMed2005

Management of postmenopausal hot flushes with venlafaxine hydrochloride: a randomized, controlled trial.

OBJECTIVE: To examine the efficacy of extended-release venlafaxine for the treatment of postmenopausal hot flushes. METHODS: Eighty postmenopausal women with more than 14 hot flushes per week were randomized to receive treatment with extended-release venlafaxine or placebo. Participants received 37.5 mg daily for 1 week, followed by 75 mg daily for 11 weeks. Daily hot flush severity scores and adverse effects were recorded by subjects. Baseline and monthly follow-up questionnaires assessed patient-perceived hot flush score, quality of life, and sexual function. Participants were treated for 12 weeks. RESULTS: Of the 80 subjects who enrolled in the study, 40 were in the treatment group and 40 in the control group. Of these, 61 completed the study (treatment, n = 29; control, n = 32). Subjective assessment at monthly visits of the effects of hot flush symptoms on daily living were significantly improved in the treatment group (P < .001). Hot flush severity scores based on daily diaries were somewhat lower in the treatment group, but the between-group difference did not reach statistical significance (P = .25). Three side effects, dry mouth, sleeplessness, and decreased appetite, were significantly more frequent in the venlafaxine group, but others, including dizziness, tremors, anxiety, diarrhea, and rash, were significantly less frequent. Ninety-three percent of participants in the venlafaxine group chose to continue treatment at the conclusion of the study. CONCLUSION: Extended-release venlafaxine, 75 mg per day, is an effective treatment for postmenopausal hot flushes in otherwise healthy women, based on a significant decrease in patient-perceived hot flush score.

Antidepressive Agents↗
PubMed2003

Intrinsic activity estimation of cannabinoid CB1 receptor ligands in a drug discrimination paradigm.

The present study estimated the apparent intrinsic activity of the cannabinoid CB1 receptor ligands CP 55,940, Delta9-tetrahydrocannabinol (Delta9-THC) and SR 141716A in a highly sensitive in vivo assay. Rats were trained to discriminate the cannabinoid CB1 receptor agonist CP 55,940 (either 0.03 or 0.014 mg/kg, i.p., t=30 min) from vehicle, in a two-lever food-reinforced procedure, and were subsequently tested with the three compounds. Although reduction of the training dose did not affect the maximum level of generalization or antagonism (>80% generalization for CP 55,940 and Delta9-THC; 0% generalization and >80% antagonism for SR 141716A), the potency of the compounds was differentially affected. Thus, the generalization curves obtained with CP 55,940 and Delta9-THC were shifted three- and sixfold to the left; whereas no potency difference was obtained for the antagonism of CP 55,940 by SR 141716A. The data are consistent with the hypothesis that the level of intrinsic activity of CP 55,940 is higher than that of Delta9-THC, and that SR 141716A may have a very low level of intrinsic activity. It is concluded that variation of the training dose increases the sensitivity of the in vivo intrinsic activity estimation of cannabinoid CB1 receptor ligands.

Analgesics↗
PubMed2005

Metabolic ratios of psychotropics as indication of cytochrome P450 2D6/2C19 genotype.

The cytochrome P450 enzymes (CYP) 2C19 and 2D6 are involved in the metabolism of many psychotropic drugs. Variability in enzyme activity results in variable metabolic capacities, affecting the metabolism of substrates. The metabolic ratio (MR) of drugs metabolized via these enzymes may therefore reflect the enzyme's activity and/or genotype. To serve as an example for different groups of medications, the selective serotonin reuptake inhibitor venlafaxine, the tricyclic antidepressant amitriptyline, and the antipsychotic risperidone were studied to examine a possible correlation between the MRs of these drugs and the CYP2C19 and/or CYP2D6 genotype. For this purpose data from routine genotyping and serum level analysis were used. The relationships between the observed metabolic ratios and CYP2D6 and/or CYP2C19 genotype were characterized using nonparametric statistical analysis. A clear correlation was observed between the CYP2D6 genotype and the metabolic ratio of venlafaxine. Genotyping of individuals with a log(MR) < -0.6 or a log(MR) > 0.2 would include all patients with an aberrant genotype but would result in a reduction of 52% of genotyping reactions. Slow metabolism of amitriptyline is correlated with a log(MR) > 0.4. Genotyping only those subjects with a log(MR) > 0.4 would result in 88% fewer genotyping reactions. For risperidone, genotyping individuals with a log(MR) > 0.4 would include all CYP2D6 poor metabolizers while reducing the number of genotyping reactions by 93%. According to these data, correlations exist between the log(MR) of venlafaxine, amitriptyline, and risperidone and the genotype of the CYP enzymes involved in their metabolism. From the ranges of log(MR) defined here, a high percentage of aberrant metabolizers can be detected even when patients are not routinely genotyped. Thus, the metabolic ratio may serve as an indication of when genotyping should be considered.

Alleles↗
PubMedDate not supplied

Efficacy of hormone therapy with and without methyltestosterone augmentation of venlafaxine in the treatment of postmenopausal depression: a double-blind controlled pilot study.

OBJECTIVE: This study evaluated the augmentation of venlafaxine with hormone therapy in the treatment of postmenopausal depression. The hormones evaluated were estrogen (0.625 mg) in combination with medroxyprogesterone acetate (2.5 mg) and methyltestosterone (2.5 mg). DESIGN: Seventy-two menopausal women (mean age: 53.6 +/- 4.27 years) diagnosed with depression (Montgomery-Asberg Depression Rating Scale [MADRS] scores > or = 20) were treated with venlafaxine and one of the following hormone therapy combinations, in a double-blind regimen: estrogen + medroxyprogesterone + methyltestosterone (group 1, n = 20); estrogen + medroxyprogesterone acetate (group 2, n = 20); methyltestosterone only (group 3, n = 16); and no hormone therapy (group 4, n = 16). Study duration was 24 weeks. Primary efficacy outcome was remission according to the MADRS, whereas secondary efficacy measures included the Clinical Global Impression (CGI), Blatt-Kupperman Index, and Women's Health Questionnaire (WHQ). RESULTS: Forty-eight patients completed the study. All groups showed significant improvement from baseline. Group 3 demonstrated significant improvement on the MADRS compared with placebo (group 4) at weeks 20 (P = 0.048) and 24 (P = 0.030); effect size 8.04 (0.83; 15.26) (P = 0.029), but also had the highest dropout rate. Groups 1 and 3 had significant CGI improvement rates compared with placebo: 42.23% (P = 0.012) and 44.45% (P = 0.08), respectively. There were no differences in the WHQ or BKI scores among the groups. CONCLUSIONS: Methyltestosterone 2.5 mg had the highest effect size compared with placebo, but the high dropout rate prevented its efficacy from being determined. Estrogen plus medroxyprogesterone, combined with methyltestosterone or otherwise, demonstrated a trend toward increased efficacy of venlafaxine. Further larger-scale clinical trials are needed to elucidate the findings of this pilot study.

Antidepressive Agents, Second-Generation↗
PubMedDate not supplied

Mirtazapine is associated with less anxiolytic use among elderly depressed patients in long-term care facilities.

BACKGROUND: Depression is a common, treatable disorder among nursing facility residents. OBJECTIVE: The purpose of this study was to examine medication use and cost between two groups of patients: (1) persons treated with mirtazapine, as compared with (2) persons taking other antidepressants. DESIGN: This study was a retrospective chart review of long-term care patients. Consultant pharmacists collected data on patients who were receiving selective serotonin reuptake inhibitors (SSRIs), venlafaxine, nefazodone, or mirtazapine. SETTING: Nursing facilities that were geographically dispersed throughout the United States. PARTICIPANTS: We studied patients greater than 65 years of age with major depressive disorder or a depression-related diagnosis and receiving antidepressant treatment for at least 3 months. Patients with bipolar-induced depression were excluded as well as those receiving tricyclic antidepressants. RESULTS: The two groups were similar in terms of age, but those receiving mirtazapine had lower body weight and body mass index. Patients on mirtazapine were less likely to be taking a sedative/hypnotic (P = 0.006). This was primarily the result of fewer patients in the mirtazapine group taking lorazepam (P = 0.03). There was no difference between the two groups regarding their use of other psychotropic medications, including multiple antidepressants, antipsychotics, anticonvulsants, acetylcholinesterase inhibitors, or appetite stimulants. Monthly medication costs were less for those patients receiving mirtazapine ($82.83) as compared with other antidepressants ($97.03) (P <0.0001). CONCLUSIONS: The results of this study suggest that patients receiving mirtazapine are less likely to be on anxiolytic/hypnotic agents. The findings also suggest that medication costs are less when mirtazapine is used compared with other antidepressants.

Aged↗
PubMed2003

Predictors of outcome following venlafaxine extended-release treatment of DSM-IV generalized anxiety disorder: a pooled analysis of short- and long-term studies.

This pooled analysis evaluated potential predictive abilities of baseline demographic factors, psychiatric history, and DSM-IV diagnostic criteria for short- and long-term outcome after treatment with venlafaxine extended release (XR) or placebo in patients with generalized anxiety disorder (GAD). Pooled data from 1,839 patients in five placebo-controlled studies of venlafaxine XR for GAD were analyzed by logistic regression. Odds ratios (ORs) were used to quantify pretreatment factors' abilities to predict response (50% reduction, baseline Hamilton Rating Scale for Anxiety [HAM-A] severity) and remission (total HAM-A score </=7) following venlafaxine XR or placebo treatment. All analyzed factors showed statistically significant outcome associations after 8 or 24 weeks of treatment, or both, in placebo- or venlafaxine-XR-treated patients or both. Substance abuse history, DSM-IV diagnostic criteria of sleep disturbances, difficulty concentrating, and restlessness had the strongest associations with outcome. Sleep disturbances predicted significant positive response in both groups, but more so in the placebo group. Restlessness consistently predicted poor response and lack of remission with either treatment; difficulty concentrating predicted short-term remission with placebo only. Substance abuse history predicted positive outcomes with placebo only. Sex, age, depression history, panic disorder history, prior benzodiazepine and nonbenzodiazepine use, being easily fatigued, muscle tension, and irritability were modestly outcome-predictive or showed treatment condition interactions. In the largest pooled analysis to date, pretreatment factors were associated with treatment outcome in patients with GAD receiving venlafaxine XR or placebo. The strongest trends emerged for history of substance abuse or dependence and symptoms of restlessness, sleep disturbance, and difficulty concentrating.

Adolescent↗
PubMed2003

A double blind comparison of venlafaxine and paroxetine in obsessive-compulsive disorder.

SUMMARY: While the usefulness of clomipramine and selective serotonin reuptake inhibitors (SSRIs) in obsessive-compulsive disorder (OCD) has been established, the efficacy of serotonin-norepinephrine reuptake inhibitors remains to be determined. This report describes the first randomized double-blind comparison study of an SNRI in patients with obsessive-compulsive disorder. The current study compares the efficacy and tolerability of venlafaxine with paroxetine. One hundred and fifty patients with primary OCD according to DSM-IV criteria were randomly assigned in a 12-week double-blind trial to receive dosages titrated upward to 300 mg/d of venlafaxine (n = 75) or 60 mg/d of paroxetine (n = 75). Primary efficacy was assessed by the change from baseline on the Yale-Brown obsessive-compulsive scale (Y-BOCS). Other assessments throughout the trial included the Hamilton depression rating scale, and the Hamilton anxiety rating scale. An intent-to-treat, last-observation-carried-forward analysis demonstrated a mean decrease on the Y-BOCS of 7.2 +/- 7.5 in the venlafaxine group and of 7.8 +/- 5.4 in the paroxetine group. In both treatment groups, a responder rate (decrease > 35% on the Y-BOCS) of approximately 40% was found. There were no significant differences between venlafaxine and paroxetine with regard to response or responder rates. The incidence of adverse events for venlafaxine and paroxetine was comparable. The most common side effects for venlafaxine were somnolence, insomnia, a dry mouth, and sweating; and for paroxetine somnolence, sweating, nausea, and headache. These results show that venlafaxine was equally effective to paroxetine in treating patients with OCD. Venlafaxine may be a useful therapy for obsessive-compulsive patients, but is not superior to SSRIs.

Adolescent↗
PubMed2004

Comparative CYP3A4 inhibitory effects of venlafaxine, fluoxetine, sertraline, and nefazodone in healthy volunteers.

An antidepressant for use in the patient receiving concomitant drug treatment, over-the-counter medications, or herbal products should lack cytochrome P-450 (CYP) 3A4 inductive or inhibitory activity to provide the least likelihood of a drug-drug interaction. This study addresses the potential of 4 diverse antidepressants (venlafaxine, nefazodone, sertraline, and fluoxetine) to inhibit or induce CYP3A4. In a 4-way crossover design, 16 subjects received clinically relevant doses of venlafaxine, nefazodone, or sertraline for 8 days or fluoxetine for 11 days. Treatments were separated by a 7- to 14-day washout period and fluoxetine was always the last antidepressant taken. CYP3A4 activity was evaluated for each subject at baseline and following each antidepressant using the erythromycin breath test (EBT) and by the pharmacokinetics of alprazolam (ALPZ) after 2-mg dose of oral ALPZ. Compared to baseline, venlafaxine, sertraline, and fluoxetine caused no apparent inhibition or induction of erythromycin metabolism (P > 0.05). For nefazodone, a statistically significant inhibition was observed (P < 0.0005). Nefazodone was also the only antidepressant that caused a significant change in ALPZ disposition, decreasing its area under the concentration-versus-time curve (AUC; P < 0.01), and increasing its elimination half-life (16.4 vs. 12.3 hours; P < 0.05) compared with values at baseline. No significant differences were found in the pharmacokinetics of ALPZ with any of the other antidepressants tested. These results demonstrate in vivo that, unlike nefazodone, venlafaxine, sertraline, and fluoxetine do not possess significant metabolic inductive or inhibitory effects on CYP3A4.

Administration, Oral↗
PubMed2004

A double-blind, placebo-controlled study of a flexible dose of venlafaxine ER in adult outpatients with generalized social anxiety disorder.

Venlafaxine extended release (ER) is a dual serotonin-norepinephrine reuptake inhibitor previously shown to be effective in the treatment of major depressive disorder and generalized anxiety disorder. This placebo-controlled, multicenter, randomized, double-blind trial examined the efficacy and safety of venlafaxine ER in outpatients with generalized social anxiety disorder. Two hundred seventy-two outpatients were randomly assigned to receive either a flexible dose of venlafaxine ER (75 to 225 mg/d) or placebo for 12 weeks. Venlafaxine ER was statistically significantly more effective than placebo as demonstrated by the Liebowitz Social Anxiety Scale total scores at weeks 4 to 12. Scores of both the Clinical Global Impression-Severity and Clinical Global Impression-Improvement scales showed that venlafaxine ER was significantly more effective than placebo at weeks 4 to 12. In addition, more venlafaxine ER-treated patients achieved CGI-Improvement scores of 1 or 2 than placebo-treated patients at weeks 4 to 12, demonstrating a greater percentage of responders to venlafaxine ER treatment. Assessment using the fear/anxiety and avoidance subscales of the Liebowitz Social Anxiety Scale and the Social Phobia Inventory Scale also showed venlafaxine ER to be more effective than placebo at weeks 4 to 12 and 6 to 12, respectively. The Sheehan Disability Inventory showed that patients in the venlafaxine ER-treated group had significantly better outcomes in social life at weeks 4 and 12, and in work at week 12. Adverse events were similar to those reported in studies of venlafaxine ER in depression and generalized anxiety disorder. Venlafaxine ER was safe, well tolerated, and efficacious in the short-term treatment of generalized social anxiety disorder.

Adult↗
PubMed2004

Efficacy and tolerability of premenstrual use of venlafaxine (flexible dose) in the treatment of premenstrual dysphoric disorder.

The objective of this study was to examine the efficacy and tolerability of intermittent dosing of venlafaxine for the treatment of premenstrual dysphoric disorder. One hundred and twenty-four women aged 18 to 45 years, with regular menstrual cycles and who reported significant premenstrual symptoms, were assessed prospectively to confirm their diagnosis of premenstrual dysphoric disorder. Twenty subjects with confirmed premenstrual dysphoric disorder entered a single-blind, placebo phase (1 cycle). Placebo nonresponders (n = 12) received 2 cycles of intermittent (premenstrual) treatment with venlafaxine (75 to 112.5 mg/d). Subjects initiated treatment 14 days before the anticipated onset of menses and discontinued it on the second day of bleeding. Doses could be adjusted after cycle 1 based on subjects' response and tolerability. Response to treatment was assessed based on changes in the Daily Rating Severity of Problems and Premenstrual Tension Syndrome Questionnaire scores from baseline (before the placebo cycle), as well as Clinical Global Impression-Severity scores. Discontinuation symptoms were assessed between treatment cycles, using the Discontinuation-Emergent Signs and Symptoms questionnaire. Eleven subjects concluded 2 cycles of intermittent dosing with venlafaxine. Nine subjects (81.8%) showed satisfactory response based on Clinical Global Impression of < or = 2. Changes in Daily Rating Severity of Problems scores and subscores (depression, physical symptoms, and anger) and in Premenstrual Tension Syndrome Questionnaire scores were significant (P < 0.05 for all comparisons, Wilcoxon tests). Intermittent treatment was well tolerated. This preliminary report suggests that premenstrual use of venlafaxine is an efficacious and well-tolerated treatment for premenstrual dysphoric disorder.

Adult↗
PubMed2004

Cost and effectiveness of venlafaxine extended-release and selective serotonin reuptake inhibitors in the acute phase of outpatient treatment for major depressive disorder.

OBJECTIVE: The purpose of this retrospective analysis was to estimate the cost and effectiveness of venlafaxine extended-release (VXR) compared with selective serotonin reuptake inhibitors in the outpatient treatment of major depressive disorder. METHODS: Pooled data from 8, 8-week, randomized, double-blind studies comparing treatment of major depressive disorder with venlafaxine/venlafaxine XR (n = 851), selective serotonin reuptake inhibitors (fluoxetine, paroxetine, fluvoxamine; n = 748), or placebo (4 studies; n = 446) were retrospectively analyzed to determine the economic implications of symptom remission from the perspective of a US third party payer and that of an employer. A decision modeling approach was used to determine cost and effectiveness ratios. RESULTS: Patients on VXR were associated with 22.8 depression-free days versus 18.6 depression-free days with the studied selective serotonin reuptake inhibitors, based on the decision model. Productive and quality-adjusted days were also expected to increase for VXR patients (22.06 vs. 19.34 and 4.56 to 9.36 vs. 3.72 to 7.63), as was the percentage of patients achieving full activity (25.9% vs. 19.6%). The expected cost per patient achieving remission of symptoms was US 1303.94 dollars and US 1514.96 dollars, and the cost per depression-free days was US 25.66 dollars and US 28.25 dollars, for the VXR and selective serotonin reuptake inhibitors groups, respectively. CONCLUSIONS: Treatment with VXR is not only expected to increase the rate of remission of symptoms but is also associated with achievement of full activity, higher number of depression-free days, productive days, and quality-adjusted days. VXR is a cost-effective treatment option for major depressive disorder.

Activities of Daily Living↗
PubMed2004

Venlafaxine for the treatment of depressive episode during the course of schizophrenia.

The emergence of depression in the course of schizophrenia is common and arouses much interest and therapeutic concern. It has been associated with a less favorable prognosis and increased incidence of suicide. However, relatively few treatment studies have been performed in this area. The use of a combination of antidepressants and antipsychotic agents is controversial. We report an open-label study carried out to evaluate the efficacy of the addition of venlafaxine in schizophrenia patients treated with antipsychotics and diagnosed with concurrent depressive episode (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria). Patients (N = 19) who did not show spontaneous improvement after 4 weeks were assigned to a 6-week trial with add-on venlafaxine. Patients were evaluated at a 1-week interval with the Hamilton Depressive Rating Scale, the Positive and Negative Syndrome Scale, and the Clinical Global Impression Scale. All 19 patients had completed the 6-week trial. Fourteen patients (74%) showed significant improvement measured with Hamilton Depressive Rating Scale and Clinical Global Impression Scale. The mean venlafaxine dose was 146 mg/d (range: 75 to 225 mg/d). In most patients, there was a parallel decrease in psychotic symptoms. We conclude that venlafaxine may have a role in the treatment of depression in patients with schizophrenia without causing exacerbation of psychosis.

Adult↗
PubMed2004

S-adenosyl-L-methionine (SAMe) as an adjunct for resistant major depressive disorder: an open trial following partial or nonresponse to selective serotonin reuptake inhibitors or venlafaxine.

BACKGROUND: The purpose of this open trial was to evaluate the safety, tolerability, and efficacy of oral S-adenosyl-L-methionine as an antidepressant adjunct among partial and nonresponders to serotonin reuptake inhibitors or venlafaxine. METHOD: Thirty antidepressant-treated adult outpatients with persisting major depressive disorder received 800 to 1600 mg of S-adenosyl-L-methionine tosylate over a 6-week trial. RESULTS: Intent-to-treat analyses based on the Hamilton Depression Rating Scale revealed a response rate of 50% and a remission rate of 43% following augmentation with S-adenosyl-L-methionine. Gastrointestinal symptoms and headaches were the most common side effects. CONCLUSION: Augmentation of selective serotonin reuptake inhibitors or venlafaxine with S-adenosyl-L-methionine warrants a placebo-controlled trial in resistant depression.

Adult↗