Research and Clinical Trials on Venlafaxine (Effexor, Efexor)

avatar image
By Dr Greg Mulhauser

This list of current clinical research trials on Venlafaxine (Effexor, Efexor) is followed by a short set of abstracts from the most recent research articles published on the drug.

Article Contents

Venlafaxine (Effexor, Efexor) Clinical Research Trials

From our searchable database at ClinicalTrialsFeeds.org, this list includes all the latest information about clinical trials involving Venlafaxine (Effexor, Efexor).

 

Get These Clinical Trials as a Newsfeed

Venlafaxine:     Get the Venlafaxine clinical trials feed.    Add the Venlafaxine clinical trials feed to your My Yahoo! page.    Add the Venlafaxine clinical trials feed to your MyMSN page.

Current Research Literature on Venlafaxine (Effexor, Efexor)

Here are abstracts for some of the latest research articles to have appeared on Venlafaxine (Effexor, Efexor):

Comparative study of the stability of venlafaxine hydrochloride sustained-release pellets prepared by double-polymer coatings and hot-melt subcoating combined with Eudragit((R)) NE30D outercoating.

Pharm Dev Technol. 2010 Mar 10;
Guan T, Wang J, Li G, Tang X
The aim of this paper was to study the comparative stability of venlafaxine hydrochloride (VEN) sustained-release pellets prepared by double-polymer coatings and hot-melt subcoating combined Eudragit((R)) NE30D outercoating. The uncoated VEN pellets, containing 45% (w/w) VEN, 45% (w/w) MCC (PH101), 10% (w/w) stearic acid and 0.5% (w/w) Carbopol974, were prepared by extrusion-spheronization. Satisfactory release profiles were obtained when VEN pellets were prepared by 4% EC subcoating combined with 4% Eudragit((R)) NE30D outercoating and 8% hot-melt subcoating combined with 6% Eudragit((R)) NE30D outercoating, respectively. The storage stability was monitored by measuring the drug release over six months storage at 40 degrees C/75% RH and at room temperature (25 +/- 2 degrees C/60% RH). The release of pellets with double-polymer coatings increased markedly, while drug release of pellets prepared by hot-melt subcoating combined with polymer coating gradually decreased. Basically, the former may be attributed to the main role of drug migration into the EC subcoating, and the latter may be caused by the fusion and resolidification of stearic acid particles and the further aging of the Eudragit((R)) NE30D outercoating. In summary, regardless of the change in release, drug dissolution met the standard requirement and the stability was acceptable during the storage period.

Selective Serotonin Reuptake Inhibitors and the Risk of Cataracts A Nested Case-Control Study.

Ophthalmology. 2010 Mar 6;
Etminan M, Mikelberg FS, Brophy JM
OBJECTIVE: Older-generation antidepressants have been associated with increasing the risk of cataracts. Although animal studies have alluded to a potential link between selective serotonin reuptake inhibitors (SSRIs) and the development of cataracts, no large population based-study has addressed this potential association. This study sought to quantify the risk of cataracts with SSRIs by conducting a pharmacoepidemiologic study using the linked administrative databases in the province of Quebec, Canada. DESIGN: Nested case-control study. PARTICIPANTS: A cohort of subjects who had received a coronary revascularization procedure from 1995 through 2004 in the province of Quebec, Canada. METHODS: Using an administrative data set, a case-control study was conducted within a cohort of Quebec residents who had received a coronary revascularization procedure from 1995 through 2004. Cases were defined as those with the first diagnosis of a cataract diagnosed by an ophthalmologist. For each case, 10 controls were selected and matched to the cases by index date, age, and cohort entry. Crude and adjusted rate ratios (RRs) and corresponding confidence intervals (CIs) were computed for current use of SSRIs. Rate ratios were adjusted for gender, corticosteroid use, statins, high blood pressure, antihypertensives, and antidiabetics. MAIN OUTCOME MEASURES: First International Classification for Disease (Ninth Revision) code for a cataract diagnosed by an ophthalmologist. RESULTS: Eighteen thousand seven hundred eighty-four cases and 187 840 controls met our study inclusion criteria. The adjusted RR for cataracts among current users of SSRIs was 1.15 (95% CI, 1.08-1.23). The risk of cataracts was highest with fluvoxamine (RR, 1.39; 95% CI, 1.07-1.80), followed by venlafaxine (RR, 1.33; 95% CI, 1.14-1.55) and paroxetine for cataract surgery (RR, 1.23; 95% CI, 1.05-1.45). The average time to diagnosis of cataracts while on SSRI therapy was 656 days. CONCLUSIONS: A possible association was found between current exposure to SSRIs, especially fluvoxamine and venlafaxine, and a future diagnosis of cataracts. The possibility that this observation may be the result of the effect of smoking, which could not be controlled for in the study, cannot be excluded. Future studies are needed to confirm this association in other populations. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Minimum Trial Duration to Reasonably Assess Long-Term Efficacy of Nonhormonal Hot Flash Therapies.

J Womens Health (Larchmt). 2010 Mar 4;
Guttuso T, Evans M
Abstract Background: Because hot flashes usually persist for years after menopause, a clinically meaningful hot flash therapy needs to have long-term efficacy; however, it is unclear for how long a therapy needs to be compared with a placebo before long-term efficacy can be reasonably deduced. The Food and Drug Administration (FDA) requires a 12-week treatment period for industry-initiated hot flash trials, whereas most academic-initiated trials have ranged from 4 to 12 weeks. We have focused on reviewing nonhormonal hot flash trials to identify inadequate trial durations as a guide toward deducing adequate trial duration to reasonably assess for long-term efficacy. Methods: An electronic database search of MEDLINE, Web of Science, and PsycINFO was performed from 1966 to May 2009 to identify target studies showing a nonhormonal hot flash therapy to be effective at early time points only to become ineffective at later time points (i.e., showing short-term but not long-term efficacy) in a randomized controlled trial (RCT). The longest early time point of efficacy from the target studies plus 1 additional week would be considered the minimum treatment duration necessary to assess for long-term efficacy. Results: Of 2518 citations, 54 RCTs met our inclusion criteria, from which 3 target studies were identified. These 3 target studies evaluated Bellergal Retard (Sandoz, East Hanover, NJ), soy, and venlafaxine and showed times of 2, 6, and 7 weeks, respectively, when the nonhormonal compound last demonstrated efficacy before subsequently losing efficacy in a single RCT. Conclusions: This analysis supports a hot flash RCT duration of at least 8 weeks to reasonably assess a nonhormonal compound's long-term efficacy.

Agomelatine in the Treatment of Major Depressive Disorder: Potential for Clinical Effectiveness.

CNS Drugs. 2010 Mar 1;
Kennedy SH, Rizvi SJ
To demonstrate the clinical effectiveness of an antidepressant drug requires evidence beyond short- and long-term efficacy, including a favourable adverse-effect profile and sustained treatment adherence. Under these conditions, patients should experience enhanced social and functional outcomes. The novel antidepressant agomelatine, a melatonergic MT(1)/MT(2) receptor agonist with serotonin 5-HT(2C) receptor antagonist activity, displays antidepressant efficacy with a favourable adverse-effect profile that is associated with good patient adherence. Specifically, agomelatine has demonstrated significant short-term (6-8 weeks) and sustained (6 months) antidepressant efficacy relative to placebo, as well as evidence of relapse prevention (up to 10 months). In head-to-head comparative studies with venlafaxine and sertraline, there was evidence of early (at 1-2 weeks) and sustained (at 6 months) advantages for agomelatine. In addition to evidence of early efficacy, agomelatine also restored disturbed sleep-wake patterns early in treatment. There was no evidence of antidepressant-induced sexual dysfunction, weight gain or discontinuation-emergent symptoms. Agomelatine has demonstrated a range of properties that suggest it could offer advantages over current treatments for major depressive disorder, although further comparative trials are still required, as is evidence from real-world clinical practice.

Pharmacologically induced/exacerbated restless legs syndrome, periodic limb movements of sleep, and REM behavior disorder/REM sleep without atonia: literature review, qualitative scoring, and comparative analysis.

J Clin Sleep Med. 2010 Feb 15; 6(1): 79-83
Hoque R, Chesson AL
BACKGROUND: Pharmacologically induced/exacerbated restless legs syndrome (RLS), periodic limb movements in sleep (PLMS), and REM behavior disorder/REM sleep without atonia (RSWA) are increasingly recognized in clinical sleep medicine. A scoring system to evaluate the literature was created and implemented. The aim was to identify the evidence with the least amount of confound, allowing for more reliable determinations of iatrogenic etiology. METHODS: Points were provided for the following criteria: manuscript type (abstract, peer-reviewed paper); population size studied (large retrospective study, small case series, case report); explicitly stated dosage timing; identification of peak symptoms related to time of medication administration (i.e., medication was ingested in the evening or at bedtime); initiation of a treatment plan; symptoms subsided or ceased with decreased dosage or drug discontinuation (for RLS articles only); negative personal history for RLS prior to use of the medication; exclusion of tobacco/alcohol/excessive caffeine use; exclusion of sleep disordered breathing by polysomnography (PSG); and PSG documentation of presence or absence of PLMS. For RLS and PLMS articles were also given points for the following criteria: each 2003 National Institutes of Health (NIH) RLS criteria met; exclusion of low serum ferritin; and exclusion of peripheral neuropathy by neurological examination. RESULTS: Thirty-two articles on drug-induced RLS, 6 articles on drug-induced PLMS, and 15 articles on drug-induced RBD/ RSWA were analyzed. CONCLUSION: Based on scores < or = 10 and trials of medication reduction/cessation, the strongest evidence available for drug induced RLS are for the following drugs: escitalopram; fluoxetine; L-dopa/carbidopa and pergolide; L-thyroxine; mianserin; mirtazapine; olanzapine; and tramadol. Since none of the PLMS articles assessed PLMI in trials of medication reduction/cessation, the strongest evidence based on scores > or = 10 are for the following drugs: bupropion, citalopram, fluoxetine, paroxetine, sertraline, and venlafaxine. Based on scores > or = 10 and/or trials of medication cessation, the strongest evidence for drug induced RBD/ RSWA is for the following drugs: clomipramine, selegiline, and phenelzine.

 

This page was last reviewed by Dr Greg Mulhauser, Sunday, 31 January 2010.

The URL of this page is:
http://counsellingresource.com/medications/trials-and-research/venlafaxine-research.html