Effexor (Venlafaxine Hydrochloride) - Summary

EFFEXOR SUMMARY

Effexor (venlafaxine hydrochloride) is a structurally novel antidepressant for oral administration.

Effexor (venlafaxine hydrochloride) is indicated for the treatment of major depressive disorder.

The efficacy of Effexor in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).

A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The efficacy of Effexor XR in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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NEWS HIGHLIGHTS

Published Studies Related to Effexor (Venlafaxine)

Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study. [2009.07]
CONCLUSION: Gen-citalopram appeared to be bioequivalent to Celexa, whereas Novo-venlafaxine XR was not bioequivalent to Effexor XR. Consequently, the Novo-venlafaxine formulation released its active ingredient more rapidly and outside the acceptable norm. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00676039.

Eight-week, placebo-controlled, double-blind comparison of the antidepressant efficacy and tolerability of bupropion XR and venlafaxine XR. [2009.07]
The efficacy, safety and tolerability of bupropion XR and venlafaxine XR was assessed and compared with placebo in adult outpatients with major depressive disorder (MDD). Adults meeting DSM-IV criteria for MDD with a minimum Hamilton Depression Rating Scale (HAMD) 17-Item total score of > or =18 were randomized to eight weeks of double-blind treatment with either bupropion XR (150 mg/day), venlafaxine XR (75 mg/day) or placebo...

The SNRI venlafaxine improves emotional unawareness in patients with post-stroke depression. [2009.06]
OBJECTIVE: Patients with stroke have a high prevalence of depression and unawareness of emotions or alexithymia. Here we investigated the effects of the serotoninergic and noradrenergic reuptake inhibitor (SNRI) venlafaxine in comparison with the SSRI fluoxetine on alexithymia severity in patients with DSM-IV post-stroke major depressive-like episode (PSD)... CONCLUSIONS: Antidepressants acting on both the serotoninergic and noradrenergic systems might represent a valid resource not only for the treatment of depression but also for improving emotional unawareness in stroke patients.

Venlafaxine versus clonidine for the treatment of hot flashes in breast cancer patients: a double-blind, randomized cross-over study. [2009.06]
PURPOSE: Breast cancer patients with treatment-induced menopause experience frequent and severe hot flashes (HF). We compared venlafaxine and clonidine for the treatment of HF with regard to side effects, efficacy, quality of life and sexual functioning... CONCLUSION: Venlafaxine and clonidine are equally, but moderately effective in HF reduction. Side effects are the main reason for drug discontinuation, occurring more often with venlafaxine.

Predictors of nonresponse to cognitive behavioural therapy or venlafaxine using glucose metabolism in major depressive disorder. [2009.05]
BACKGROUND: Longitudinal neuroimaging investigations of antidepressant treatment offer the opportunity to identify potential baseline biomarkers associated with poor outcome... CONCLUSION: Our current findings are consistent with those reported in previous studies of relative hyperactivity in the ventral anterior cingulate cortex in treatment-resistant populations.

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Clinical Trials Related to Effexor (Venlafaxine)

Study Evaluating Effexor® (Venlafaxine) in Achieving Response and Maintaining Remission [Completed]

Venlafaxine for Hot Flashes After Breast Cancer [Completed]
The purpose of this study is to evaluate Venlafaxine as a treatment option for hot flashes in breast cancer survivors. The goals of this study are to assess the effectiveness and toxicity of venlafaxine hydrochloride and identify the psychological, behavioral, and physical outcomes associated with relief of hot flashes in women following treatment for breast cancer.

A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain [Completed]
This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may receive Venlafaxine or placebo during the course of the trial. All subjects will, in fact, receive placebo for the first two weeks. All subjects will then be placed on 150-225 mg per day of venlafaxine. Primary outcome assessment will compare pain intensity at 2 weeks (after placebo) to that at 12 weeks (after 10 weeks of Venlafaxine treatment).

Study Hypothesis:

In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 150-225 mg Venlafaxine per day over 10 weeks will provide significant additional pain relief over that achieved with placebo (more than 30% reduction after Venlafaxine treatment).

Psychosocial and Medication Treatment for Anxiety in Alcoholism [Active, not recruiting]
The proposed project is written as a "typical clinical practice" test and is a fully-controlled trial of a combined anxiety-focused CBT and pharmacotherapy (venlafaxine; CBT-VEN) delivered for patients with comorbid alcohol-use and anxiety disorders. The CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication. One hundred and eighty participants will be recruited and, subsequent to a platform of outpatient treatment for alcoholism, will be randomly assigned to a 12-week treatment condition. All treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo. The treatments will conclude with a 2-week medication/placebo taper. Follow-up assessments will be conducted at post-treatment and at 3, 6, 9, and 12-months. The long-term objectives of this research are to develop a real-world combination of psychosocial and pharmacological treatments for patients with comorbid alcohol-use and anxiety disorders that compromise prognosis, and to evaluate the effectiveness of combined psychosocial and pharmacological treatments that target anxiety among patients with this comorbidity.

Aripiprazole and Effexor XR Drug Interaction Study [Completed]
The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of venlafaxine in healthy subjects. The safety and tolerability of aripiprazole and venlafaxine co-administration will also be studied.

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PATIENT REVIEWS / RATINGS / COMMENTS

Effexor review by 56 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		recurrent depression
Dosage & duration:		2 75 mg twice daily taken daily for the period of ongoing
Other conditions:		adhd
Other drugs taken:		concerta
		Reported Results
Benefits:		This drug turned my severe recurrent depression around.
Side effects:		None.
Comments:		This drug changed my life. I have taken every antidepressant in the book. I received some benefit from most of them but my depression always returned and many of them had unpleasant side effects, including weight gain and constipation. This drug helped me enjoy life again. I still have occasional bouts of depression due to life cirsumstances but they are much briefer and less severe. I feel much more outgoing and enjoy being around people more. I no longer want to withdraw from the world and now face the world with much more confidence. For people worried that this drug produces an "artificial" feeling of happiness--this is not the case. This is the way people are supposed to feel. you will still have a normal range of moods. I only wish this drug had existed sooner--my whole life would have been differnt.

Effexor review by 47 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		depression
Dosage & duration:		150mg daily taken 75mg twice daily for the period of 7 years
Other conditions:		IBS, chronic tiredness, joint pain
Other drugs taken:		none
		Reported Results
Benefits:		helped the depression initially, was far more positive during the years I took it, but the efficacy of the drug began to deteriate, and the onset of new side effects led me to try to live without the treatment
Side effects:		initially, not many, some loss of concentration when driving longer than half hour periods, eyes felt very heavy, and it felt like part of my brain had shut down, struggled not to fall to sleep. after some time, about six years, I started to get night sweats, very uncomfortable, and mood swings. I thought it might be hormaonal, but after taking away the drug , the symptoms alleviated.
Comments:		I now feel that I have suffered fibromyalgia for a long time, and part of the reason I was depressd was I found it hard to deal with the pain i was feeling at the time, I had two very young children , and was not diagnosed with a condition . If I had understood my condition better, I may have managed the fibromyalgia better. I was pushing my body too hard, as I felt frustrated t not managing everything better, and the cycle of depression continued. I have come off the venlafaxine, and the symptoms of pain, particularly in the morning have returned, but I can manage them better, knowing it is not symptomatic of a seriously damaging condition, and that it is 'normal' for me. I pace myself better, and no longer have the demands of very young children , so can do that easier. I like being 'drug' free, although I do supplement with fish oils and 5 HTP

Effexor review by 16 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		Depression and Anxiety
Dosage & duration:		175mg taken once daily for the period of one month
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Proven effective with adults and was tried with me to combat severe depression, regardless of the fact that it is not normally recommended for adolescents. Though starting at 37.5 mg, the psychiatrist quadrupled the dosages within one month's time to attempt to make a dent on my emotional condition.
Side effects:		As the dosage increased, the lack of effect turned into a complete removal of affect as well as a persistent feeling of listlessness and heaviness (like having weights on limbs and chest).
Comments:		Though starting at 37.5 mg, the psychiatrist quadrupled the dosages within one month's time to attempt to make a dent on my emotional condition. The month was ended abruptly due to hospitalization for attempted suicide by overdose. I was not weened off of the medication. The doctor was then brought before a committee for misconduct in prescribing Effexor to a minor as well as disregarding warning signs of a suicidal youth. This was the worst month in regards to my depression and anxiety, and was a definite reversal in any progress that was accomplished with a different doctor on a different medication.