Comparison study of venlafaxine and paroxetine for the treatment of depression in elderly Chinese inpatients.
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Efficacy and tolerability of venlafaxine in geriatric outpatients with major depression: a double-blind, randomised 6-month comparative trial with citalopram.
BACKGROUND: The objectives of the study were to compare efficacy and tolerability of venlafaxine ER 75-150 mg/day with that of citalopram 10-20 mg/day in elderly patients with major depression according to DSM-IV criteria. METHODS: A randomised, double-blind, parallel group 6-month study. Efficacy was assessed by MADRS, CGI Global Improvement, CGI Severity of Illness and GDS-20 scores and safety by physical examinations, vital signs, adverse events and UKU side effect rating. Plasma levels of venlafaxine, its major metabolite O-desmethylvenlafaxine and citalopram were followed. RESULTS: One hundred and fifty-one male and female patients (64-89 years) were enrolled and 118 patients completed the study. Comparable improvements in MADRS, CGI Severity of Illness, CGI Global Improvement and GDS-20 were observed during venlafaxine and citalopram treatment. The MADRS remission rate was 19% for venlafaxine and 23% for citalopram. Side effects were common during both treatments but differed in tremor being more common during citalopram and nausea/vomiting during venlafaxine treatment. There were no clinically significant changes in blood pressure or body weight. CONCLUSION: The observed benefits of venlafaxine treatment in elderly patients with major depression were similar to those observed in younger adults as were reported adverse events and side effects. Treatment with venlafaxine ER was well tolerated and induced beneficial effects of similar magnitude as those of citalopram.
Aged↗
An open trial of venlafaxine for the treatment of late-life atypical depression.
OBJECTIVES: The atypical subtype in patients with major depressive disorder is characterized by mood reactivity, significant weight gain or increase in appetite, hypersomnia, leaden paralysis and a long-standing pattern of interpersonal rejection sensitivity. Though atypical depression is well documented in younger patients, little attention has been paid to the atypical subtype in samples of late-life depressed patients. This study reports the patient characteristics and treatment results of an eight-week open-label trial of venlafaxine in a sample of older depressed patients with atypical subtype. METHODS: Patients received fixed dosing schedule (up to 300 mg/day) of venlafaxine (Effexor XR) for 8 weeks. RESULTS: In this sample of 17 patients, the mean age was 65.6 years and 77% were female. Most strikingly, 53% of patients presented with late-onset atypical depression defined as first episode after the age of 50. Fifteen of the 17 patients (88%) completed the eight-week treatment trial. The mean score on the HRSD 24-item decreased from 22.2 +/- 5.1 at baseline to 11.8 +/- 8.9 (p<0.001), and the mean total atypical item score decreased from 6.2 +/- 1.6 to 2.8 +/- 2.0 (p < 0.001). Remission was defined as a final HRSD < or = 10 and a 50% reduction in baseline HRSD score. The intent-to-treat remission rate was 65% and the completer remission rate was 73%. CONCLUSIONS: In this sample of late-life patients with atypical depression venlafaxine treatment was reasonably effective and well tolerated. However, the effectiveness of venlafaxine in this study must be considered in the context that this was an open trial of antidepressant medication. Insufficient attention has been given to the atypical subtype in late-life depression. Whether late-onset atypical depression is significantly different from early-onset atypical depression, and whether late-onset patients with atypical depression are significantly different from late-onset patients with other depressive subtypes are questions of compelling interest.
Age of Onset↗
Venlafaxine extended-release in patients older than 80 years with depressive syndrome.
OBJECTIVES: The aim of this evaluation was to assess the efficacy and safety of venlafaxine extended-release (ER) in very old primary care out-patients with depressive syndrome and associated anxiety symptoms. METHODS: This was an observational, naturalistic, multicenter, prospective, open-label study in an outpatient population with a diagnosis of depressive syndrome with anxiety symptoms. Minimum scores of 17 and 10 on the Hamilton Rating Scale for Depression (HAM-D(17)) and Anxiety (HAM-A), respectively, were required. Daily doses of 75 mg to 225 mg of venlafaxine extended release (ER) were administered for 24 weeks. Effectiveness for depressive-anxious symptomatology was assessed using the HAM-D(17) and HAM-A scales. PATIENTS: The 97 patients discussed in this report are a subgroup comprising all elderly patients, aged >or= 80 years, who were part of the larger observational, naturalistic, multicenter, prospective, open-label study and who had received venlafaxine ER for a maximum duration of 24 weeks. RESULTS: At endpoint, remission rates were 57.1% (HAM-D(17) <or=7), 66.2% (HAM-A <or= 7), and 52% (HAM-D(17) <or=7 and HAM-A <or= 7). Twenty patients (20.6%) dropped out or were withdrawn. Adverse events were reported by seven (7.2%) patients, none were reported as serious. CONCLUSIONS: Venlafaxine ER was shown to be an effective and safe drug for the treatment of very elderly primary care patients with depressive syndrome and associated anxiety symptoms.
Aged, 80 and over↗
CYP2D6 genotype and venlafaxine-XR concentrations in depressed elderly.
INTRODUCTION: The elderly are at increased risk for medication-related adverse events. Recent reports indicate that venlafaxine may put the elderly at increased risk of cardio- and cerebrovascular adverse events. We investigated the relationship between the CYP2D6 polymorphism and steady-state plasma concentration of venlafaxine (VEN) and its primary metabolite o-desmethylvenlafaxine (ODV) in elderly participants receiving venlafaxine-XR for major depression in order to explore the contribution of pharmacogenetics to medication tolerability. METHODS: Forty-six elderly participants received venlafaxine-XR for the treatment of major depression. CYP2D6 genotype and steady-state plasma levels of VEN and ODV were determined. RESULTS: Sixty-five percent of participants were homozygous of the wild type (WT) allele, whereas 35% carried one or more variant alleles associated with intermediate and poor 2D6 metabolizer status. VEN concentration per unit dose was significantly higher and ODV concentration per unit dose was significantly lower in participants who carried one or more variant alleles compared to participants who were homozygous for the WT allele. The VEN and ODV concentrations per unit dose were also correlated with creatinine clearance. CYP2D6 genotype was not associated with medication associated side-effects. CONCLUSIONS: Plasma dose-corrected concentrations of VEN and ODV correlated with genetically determined CYP2D6 enzymatic activity in depressed elders treated with venlafaxine-XR. This relationship was not masked by the effects of age-related illness or polypharmacy. Future clinical application of pharmacogenetics to examine 2D6-dependent medications may help reduce the incidence of medication adverse events particularly in those elders at higher risk for medication adverse events due to impaired renal or cardiac function.
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Hyponatraemia in elderly psychiatric patients treated with Selective Serotonin Reuptake Inhibitors and venlafaxine: a retrospective controlled study in an inpatient unit.
OBJECTIVE: To determine the prevalence of hyponatraemia associated with selective serotonin reuptake inhibitor (SSRI) and venlafaxine use in elderly patients compared to that in elderly patients not prescribed these drugs, while controlling for age, sex, depression status and illnesses or prescribed medications also associated with hyponatraemia. Design and setting Retrospective controlled analysis in a 36-bed inpatient unit for elderly psychiatric patients in Melbourne. PATIENTS: Inpatients (199) with a mean age of 74.2 years of whom 74 were prescribed an SSRI or venlafaxine. RESULTS: Patients on SSRIs or venlafaxine were 5.6 times as likely as patients not so treated to have hyponatraemia. Thirty-nine percent of patients on an SSRI or venlafaxine had hyponatraemia compared with 10% of controls. Ten of the 14 patients on venlafaxine were hyponatraemic. Controlling for thiazide status did not reduce the odds of these patients having hyponatraemia and taking an SSRI or venlafaxine was still strongly associated with hyponatraemia after also controlling for age, sex, and depression status, consumption of other drugs potentially causative of hyponatraemia and medical illness severity (Odds Ratio (OR) 3.5, p = 0.008). CONCLUSIONS: SSRI and venlafaxine use is strongly associated with the presence of hyponatraemia in a population of elderly psychiatric inpatients and the association is not due to confounding by age, sex, depression status, medical illness severity or consumption of other drugs. Elderly patients on SSRIs or venlfaxine should have sodium levels checked before and after commencement of antidepressant treatment.
Aged↗
Interaction between ECT and venlafaxine.
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Synergetic effects of quetiapine and venlafaxine in preventing the chronic restraint stress-induced decrease in cell proliferation and BDNF expression in rat hippocampus.
Clinical studies show better response rates of patients with depression and schizophrenia to combinations of atypical antipsychotics and antidepressants, compared to responses to either type of drugs alone. Animal studies demonstrate that some antipsychotics and antidepressants increase neurogenesis and BDNF expression in the hippocampus, which is reduced in volume in patients with depression or schizophrenia. We hypothesized that the better therapeutic effects of combined treatment seen in schizophrenia and depression patients are related to the additive or synergistic effects of combined treatment on hippocampal neurogenesis and BDNF expression. To test this hypothesis, we investigated the effects of chronic administration of quetiapine, venlafaxine, and their combination, on hippocampal cell proliferation and BDNF expression in rats, when subjected to chronic restraint stress (CRS) during the last 2 weeks of a 3-week drug administration period. We found (1) CRS decreased hippocampal cell proliferation and BDNF expression; (2) chronic administration of quetiapine or venlafaxine dose-dependently prevented these decreases in hippocampal cell proliferation and BDNF expression caused by CRS (6 h/day for 14 days); (3) the combination of lower doses of quetiapine (5 mg/kg) and venlafaxine (2.5 mg/kg) increased hippocampal cell proliferation and prevented BDNF decrease in stressed rats, whereas each of the drugs exerted mild or no effects; (4) individual higher doses of quetiapine (10 mg/kg) or venlafaxine (5 mg/kg) exerted effects comparable to those produced by their combination. These results support our hypothesis and can lead to future studies to develop new therapeutic approaches for treatment-resistant depression and the negative symptoms of schizophrenia.
Animals↗
An overview of the clinical efficacy of mirtazapine.
Mirtazapine is at least as effective as the tricyclic antidepressants and trazodone in a wide range of patient subgroups including in- and out-patients with moderate to severe depression. It also appears to be at least as effective as the serotonin and noradrenaline reuptake inhibitor venlafaxine in the treatment of severely depressed melancholic patients. When compared with the selective serotonin reuptake inhibitors (SSRIs), mirtazapine shows a significantly earlier onset of action. Further analysis of a study comparing mirtazapine with the SSRI paroxetine indicated that early improvement was a highly sensitive predictor of later stable response for both drugs. The positive predictive value of an early improvement was significantly higher during mirtazapine treatment compared with paroxetine. The negative predictive value approached maximum values as early as week 2 with mirtazapine and week 3 with paroxetine. This suggests that the predictability of the response to treatment is better with mirtazapine than with paroxetine.
Adrenergic Uptake Inhibitors↗
Safety and efficacy of high dose of venlafaxine XL in treatment resistant major depression.
AIM: The aim of the study was to look at efficacy and the safety profile of high dose (450-600 mg) venlafaxine XL in five patients with treatment resistant major depressive illness. METHODS: Five patients with treatment resistant depression were treated with high dose venlafaxine XL. Efficacy was evaluated using the Montgomery-Asberg depression rating scale (MADRS), the 21-item Hamilton rating scale for depression (HAM-D-21) and the clinical global impressions (CGI) scale. Level of functioning was evaluated by social adaptation self-evaluation scale (SASS). Body weight, supine pulse and blood pressure were recorded. RESULTS: The response rate was based on a 50% decrease in MADRS and HAM-D scores between weeks 1 and 24. There was a more than 50% decrease in MADRS scores in 3 of 5 patients and 4 of 5 patients in HAM-D scores. There was a trend to improvement of SASS scores in three of the study patients and in two of them the mean scores were within the normal range. Supine pulse and blood pressure remained stable in four patients, except in one patient where there was a slight increase although the final reading at week 24 was normal. Weight was relatively stable in all three patients where it was recorded, but in one patient there was a slight increase which may have been due to an atypical neuroleptic the patient was taking at the time. CONCLUSION: High dose venlafaxine was safe, well tolerated and effective in this small number of severe treatment resistant patients with major depression and it also improved social functioning.
Adult↗
The treatment of depression with different formulations of venlafaxine: a comparative analysis.
Venlafaxine is the first of a group of antidepressants that show dual reuptake inhibition of serotonin and noradrenaline (SNRIs). Originally marketed in an immediate release (IR) formulation a microencapsulated, extended release (XR) formulation is now available. Significant differences exist between these two formulations with respect to pharmacokinetic parameters which have an impact on clinical use. The XR has lower maximum plasma concentrations (Cmax) and achieves these at a later time (higher Tmax). The longer apparent elimination half-life of the drug after single XR doses suggests that it is suitable for once daily dosing compared with the twice daily dosing regimen required by the IR formulation. With respect to antidepressant efficacy the XR formulation is equivalent to other marketed antidepressants and to the IR formulation. Consistent with its pharmacokinetic properties the use of the XR formulation is associated with less nausea and dizziness at the initiation of therapy. While in clinical usage XR might be expected to increase compliance with medication and to reduce discontinuation syndromes there are few comparative studies for which this has been evaluated. The XR formulation of venlafaxine is no worse than the IR form with respect to tolerability and offers some benefits to patients in terms of ease of use. On the other hand there does not appear to be any increase in the efficacy of the active agent.
Antidepressive Agents, Second-Generation↗
Efficacy of Venlafaxine ER in patients with social anxiety disorder: a double-blind, placebo-controlled, parallel-group comparison with paroxetine.
This study evaluated the anxiolytic efficacy, safety and tolerability of a flexible dose of venlafaxine extended release (ER) compared with placebo and paroxetine in the short-term treatment of generalized social anxiety disorder (SAD). Adult outpatients with generalized SAD (n = 434) were randomized to receive capsules of venlafaxine ER 75 mg to 225 mg/day, paroxetine 20 mg to 50 mg/day, or placebo for 12 weeks. The primary efficacy variable was the Liebowitz social anxiety scale total score. Secondary efficacy variables included the patient-rated social phobia inventory and the proportion of responders in each group (a responder was defined as having a clinical global impression-improvement score of 1 or 2). Treatment with venlafaxine ER was associated with significantly greater improvement than treatment with placebo for all primary and secondary efficacy variables (p < 0.05). No significant differences in primary or secondary efficacy variables were observed between the venlafaxine ER and paroxetine groups. The week 12 response rates were 69%, 66% and 36% for the venlafaxine ER, paroxetine and placebo groups, respectively. Both active treatments were generally well tolerated and were associated with a similar incidence of adverse events. This study shows that venlafaxine ER is an effective, safe and well-tolerated drug treatment for SAD.
Adult↗
Very low dose quetiapine-induced galactorrhea in combination with venlafaxine.
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Adult↗
Clinical experience with dual action antidepressants in different chronic pain syndromes.
A common psychopharmacology between pain and depression suggests that compounds inhibiting the reuptake of serotonin and/or noradrenaline are likely to produce relief from chronic pain. Indeed tricyclic antidepressants have been a standard treatment of chronic pain for many years. In spite of their improved tolerance, selective serotonin reuptake inhibitors do not appear to be particularly effective in the treatment of pain. Recently, a number of open and controlled trials with members of the new selective serotonin and noradrenaline reuptake inhibitor class of antidepressants, such as venlafaxine, milnacipran and duloxetine, suggest that these compounds may be more effective in relieving pain than selective inhibitors of serotonin reuptake. Wherever valid comparisons have been made the newer dual action drugs appear to be as effective as the tricyclics and considerably better tolerated. Dual action antidepressants are thus likely to become a widely used treatment of chronic pain both associated with and independent of depression.
Antidepressive Agents↗
Comparison of efficacy and tolerability of reboxetine and venlafaxine XR in major depression and major depression with anxiety features: an open label study.
OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of reboxetine in the treatment of major depressive disorder (MDD) and MDD with anxiety features to venlafaxine XR. METHOD: Patients with MDD, aging 18 between 65 years, were randomly allocated to two groups receiving either open-label venlafaxine XR capsules (n = 50) or reboxetine tablets (n = 43). Subjects were administered Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Scale (HAM-A) at baseline and 2, 4, 7, 10 weeks after the baseline visit. RESULTS: Response rates to antidepressant treatment were significantly higher in the venlafaxine XR group at 10th week. When patients having anxious depression were analysed separately; response rate for anxiety of reboxetine group was significantly higher at 7th week only. Mean number of side effects were significantly higher in reboxetine group. Only one subject in each group was dropped out due to side effect. CONCLUSION: We may suggest that reboxetine is as effective and tolerable as venlafaxine XR in the treatment of MDD and MDD with anxiety features, and it may be considered a treatment option to venlafaxine XR.
Adolescent↗
Effects of adjunctive antidepressant therapy with quetiapine on clinical outcome, quality of sleep and daytime motor activity in patients with treatment-resistant depression.
OBJECTIVE: To investigate the effects of antidepressant therapy plus quetiapine on major depression, motor activity, daytime sleepiness and quality of sleep. METHODS: Patients (N = 27) with major depressive disorder received a standard antidepressant treatment (Venlafaxine, Escitalopram) plus flexible dose of quetiapine. Patients' depression was monitored with HAM-D-21, motor activity was continuously measured with actigraphy and sleep parameters with the Pittsburgh Sleep Quality Index (PSQI) over 4 weeks. RESULTS: Whereas depression, quality of sleep and daytime sleepiness showed a significant improvement over 4 weeks, change of daytime motor activity was significant only between the wash out period and the last 2 days of the study. Repeated measures of variance indicate an independent influence of quetiapine on improved depression, motor activity and sleep. While we found only a mild decrease of daytime sleepiness during the first week of treatment, the further decline of daytime sleepiness got significant after 2 weeks of treatment with quetiapine, even at high mean daily doses and despite the sedative effects of quetiapine. CONCLUSIONS: Antidepressant treatment plus quetiapine is possibly a suitable treatment strategy to improve clinical depression, quality of sleep and motor activity. Future research is needed to understand the pharmacological interactions between antidepressants and quetiapine in major depression.
Adult↗
Venlafaxine induces P-glycoprotein in human Caco-2 cells.
PURPOSE: The objective of this study was to evaluate the effect of a treatment with venlafaxine on the expression of multidrug resistance-associated protein (MRP) gene and multidrug resistance-related proteins (MDR) in human colon carcinoma cells (Caco-2) compared to a known P-glycoprotein (PGY1) inducer, rifampine. METHODS: Caco-2 cells were treated with venlafaxine (50 microM, 100 microM, 250 microM, and 500 microM) and rifampin (25 microM and 50 microM) to test the possible induction of MRP and MDR expression. The treatment times used were 1.5, 3, 6, 12, 24, 48, and 72 h. RNA was isolated from the cells, and MDR and MRP genes were amplified using PCR. RESULTS: Both venlafaxine and rifampine had the most dramatic effect at the 50 microM concentration. There was an increase in MDR and MRP expression in Caco-2 cells after the acute treatment (1.5, 3, and 6 h) with venlafaxine. These results were similar to those with rifampine. CONCLUSIONS: PGY1 contributes to renal and biliary elimination of drugs by transporting the drug out of the cell and back into the intestinal lumen, where drugs may be further metabolized by intestinal enzymes such as Cytochrome P (CYP)-450 3A4. Its function is to limit the bioavailability of orally administered compounds. Due to the increase in MDR and MRP gene expression seen after the acute treatment with venlafaxine, there could be a potential drug-drug interaction with other medications that are metabolized via CYP450-3A4 when coadministered with venlafaxine.
ATP Binding Cassette Transporter, Subfamily B, Mem↗
AO-128, alpha-glucosidase inhibitor: antiobesity and antidiabetic actions in genetically obese-diabetic rats, Wistar fatty.
Antiobesity and antidiabetic actions of the alpha-glucosidase inhibitor AO-128 were examined using genetically obese-diabetic rats, Wistar fatty. Ten-week-old, male fatty rats were kept on CE-2 diet containing 10 or 25 ppm of AO-128 for 4 weeks. The average drug intake was calculated to be 0.74 or 1.78 mg/kg/day from the average food intake, respectively. The intestinal maltase and sucrase activities were decreased by AO-128 in a dose-related fashion. Food intake of fatty rats treated with AO-128 was decreased throughout the experiment. This decrease in food intake could hardly be explained only by diarrhea which occurred for the first 5 days of the administration of AO-128. AO-128 normalized hyperglycemia and markedly reduced hypertriglyceridemia and hyperinsulinemia in fatty rats. In addition, AO-128 decreased body weight gain, food efficiency, epididymal adipose tissue weight, carcass weight, and body fat deposition. These findings indicate that AO-128 may be useful for treating human obesity and diabetes.
Animals↗