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Serzone (Nefazodone Hydrochloride) - Summary

 
 



Suicidality in Children and Adolescents

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of SERZONE or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SERZONE is not approved for use in pediatric patients. (See WARNINGS and PRECAUTIONS: Pediatric Use.)

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.

 

SERZONE SUMMARY

SERZONE®
(nefazodone hydrochloride)
Tablets

SERZONE® (nefazodone hydrochloride) is an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant.

SERZONE (nefazodone hydrochloride) is indicated for the treatment of major depressive disorder. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with SERZONE treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first.

The efficacy of SERZONE in the treatment of major depressive disorder was established in 6–8 week controlled trials of outpatients and in a 6-week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY).

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 must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The efficacy of SERZONE in reducing relapse in patients with major depressive disorder who were judged to have had a satisfactory clinical response to 16 weeks of open-label SERZONE treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (ie, 52 weeks total), the physician who elects to use SERZONE for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.


See all Serzone indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Serzone (Nefazodone)

Medical News Today: Tips for finding motivation with depression
Source: Featured Health News from Medical News Today [2017.02.18]
Learn about the benefits of physical activity for people with depression, how socializing may help, and what depression triggers should be avoided.

Tips for finding motivation with depression
Source: Depression News From Medical News Today [2017.02.18]
Learn about the benefits of physical activity for people with depression, how socializing may help, and what depression triggers should be avoided.

Is it depression or dementia? Brain SPECT imaging helps distinguish them
Source: Depression News From Medical News Today [2017.02.17]
Neuroimaging of decreased blood flow in specific regions of the brain can differentiate between depression and cognitive disorders, according to a new report in the Journal of Alzheimer's Disease.

Hey Fellas, Depression Can Strike New Dads, Too
Source: MedicineNet Depression Specialty [2017.02.17]
Title: Hey Fellas, Depression Can Strike New Dads, Too
Category: Health News
Created: 2/16/2017 12:00:00 AM
Last Editorial Review: 2/17/2017 12:00:00 AM

Improving Quality of Life in Depression
Source: Medscape Psychiatry & Mental Health Headlines [2017.02.16]
Dr Peter Yellowlees discusses the effect of psychotherapy for depression on patients' quality-of-life measures based on a meta-analysis on 44 randomized clinical trials.
Medscape Psychiatry

more news >>

Published Studies Related to Serzone (Nefazodone)

Patient preference as a moderator of outcome for chronic forms of major depressive disorder treated with nefazodone, cognitive behavioral analysis system of psychotherapy, or their combination. [2009.03]
CONCLUSIONS: These results suggest that patient preference is a potent moderator of treatment response for patients with chronic forms of MDD; however, relatively low proportions of the patient sample preferred one of the monotherapies, participants were not blinded to treatment assignment, and there was no placebo group.

A preliminary trial: double-blind comparison of nefazodone, bupropion-SR, and placebo in the treatment of cannabis dependence. [2009.01]
The present study investigated the efficacy of nefazodone and bupropion-sustained release for treating cannabis dependence. A double-blind, placebo-controlled, piggy back design was employed to assess if nefazodone and bupropion-sustained release increased the probability of abstinence from cannabis and reduced the severity of cannabis dependence and cannabis withdrawal symptoms during a 13-week outpatient treatment program...

Nefazodone in the treatment of generalized social phobia: a randomized, placebo-controlled trial. [2007.02]
CONCLUSION: These findings suggest that nefazodone is not an effective agent in the treatment of GSP. These data parallel some recent findings with the use of the SSRI fluoxetine in GSP. The lack of efficacy of 2 serotonergic antidepressants in GSP suggests that serotonin reuptake inhibition may not be the only mechanism of action required for efficacy to occur in the treatment of GSP.

Chronic depression: medication (nefazodone) or psychotherapy (CBASP) is effective when the other is not. [2005.05]
CONTEXT: Although various strategies are available to manage nonresponders to an initial treatment for depression, no controlled trials address the utility of switching from an antidepressant medication to psychotherapy or vice versa. OBJECTIVE: To compare the responses of chronically depressed nonresponders to 12 weeks of treatment with either nefazodone or cognitive behavioral analysis system of psychotherapy (CBASP) who were crossed over to the alternate treatment (nefazodone, n = 79; CBASP, n = 61)... CONCLUSIONS: Among chronically depressed individuals, CBASP appears to be efficacious for nonresponders to nefazodone, and nefazodone appears to be effective for CBASP nonresponders. A switch from an antidepressant medication to psychotherapy or vice versa appears to be useful for nonresponders to the initial treatment.

Nefazodone in out-patient treatment of inhaled cocaine dependence: a randomized double-blind placebo-controlled trial. [2005.04]
AIMS: To assess the efficacy of oral nefazodone in the treatment of cocaine dependence. DESIGN: A 10-week randomized double-blind clinical trial was performed... CONCLUSIONS: These results do not support the indication of nefazodone for out-patient treatment of inhaled cocaine dependence with or without other associated drug dependence diagnoses.

more studies >>

Clinical Trials Related to Serzone (Nefazodone)

Nefazodone in the Treatment of Cocaine Dependence and Depression - 4 [Completed]

Nefazodone in the Treatment of Social Phobia [Completed]
The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD).

Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10 [Completed]
The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use in depressed and non-depressed females with cocaine abuse/dependence.

Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals [Completed]
Recent research has identified the following withdrawal symptoms to be associated with abruptly stopping marijuana use: anxiety, irritability, bodily aches and pains, and difficulty sleeping. These symptoms resemble those of both depression and nicotine withdrawal, suggesting that a similar treatment drug may be useful. This study will evaluate the effectiveness of two antidepressant drugs, bupropion and nefazodone, in reducing withdrawal symptoms in marijuana dependent individuals.

Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3 [Completed]

more trials >>

Reports of Suspected Serzone (Nefazodone) Side Effects

Weight Increased (3)Drug Ineffective (2)Abortion Spontaneous (2)Suicidal Ideation (2)Blood Cholesterol Increased (2)Crying (2)Blood Glucose Increased (2)Migraine (2)Blood Pressure Increased (2)Vomiting (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Serzone has an overall score of 7. The effectiveness score is 8 and the side effect score is 7.33. The scores are on ten point scale: 10 - best, 1 - worst.
 

Serzone review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   sleep distubance/mild depression
Dosage & duration:   150 mg. daily taken 1x daily for the period of 3 years
Other conditions:   osteopenia
Other drugs taken:   Fosamax
  
Reported Results
Benefits:   After just three weeks, I felt immensely better and began to enjoy the things that previously I had enjoyed--liked gardening and playing tennis. I also slept soundly. It lifted my mood dramatically, but never made me manic. I also felt more like being with people and noticed that I was no longer so preoccupied with myself or awkwardly self-consciousness. In short, I wasn't depressed and anxious anymore!
Side effects:   I gained about 5 lbs, which was not a problem for me since I'm slender to begin with. There was also some mild constipation, well not really constipation, but a decrease in the number of daily bowel movements. To offset that, I just drank more water. Not a big deal.
Comments:   I used this drug after trying Wellbutrin, which made me too restless and hyper. It was proscribed by a psychiatrist, who was very well versed in pharmacology, for a depression that came about during menopause. I took it regularly for three years; it completely stopped negative thinking and enabled me to sleep deeply for the first time in several years. I had regular liver check-ups, but never had any decrease in correct liver functioning. After three years, I felt I was ready to cut back on the medication, which I did very, very gradually over the next year and a half so that there was no withdrawal period at all. I've been fine without it now for two years.

 

Serzone review by 30 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   200 mg taken twice daily for the period of 10 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Lessened depression
Side effects:   It made me groggy during the day & made me sleep the sleep of the dead at night (not such a bad side effect). I also had dry mouth & it sometimes caused mild nausea on an empty stomach.
Comments:   I took this med after trying others for depression. It worked pretty well. I decided to taper my dose down when I got pregnant & was off completely when my son was about one month old. Since then, I have kept my depression under control effectively through diet & exercise.

 

Serzone review by 30 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   200 mg taken twice daily for the period of 10 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Lessened depression
Side effects:   It made me groggy during the day & made me sleep the sleep of the dead at night (not such a bad side effect). I also had dry mouth & it sometimes caused mild nausea on an empty stomach.
Comments:   I took this med after trying others for depression. It worked pretty well. I decided to taper my dose down when I got pregnant & was off completely when my son was about one month old. Since then, I have kept my depression under control effectively through diet & exercise.

See all Serzone reviews / ratings >>

Page last updated: 2017-02-18

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