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.
|
NEWS HIGHLIGHTSMedia Articles Related to Serzone (Nefazodone)
Depression As Deadly As Smoking, But Anxiety May Be Good For You
Source: Anxiety / Stress News From Medical News Today [2009.11.19]
A study by researchers at the University of Bergen, Norway, and the Institute of Psychiatry (IoP) at King's College London has found that depression is as much of a risk factor for mortality as smoking.
At-Risk College Students Reduce HBP, Anxiety, Depression Through Transcendental Meditation
Source: Anxiety / Stress News From Medical News Today [2009.11.18]
The Transcendental Meditation technique may be an effective method to reduce blood pressure, anxiety, depression, and anger among at-risk college students, according to a new study to be published in the American Journal of Hypertension, December 2009.
Symptoms Of Depression Improved By Motivational "Women-Only" Cardiac Rehab
Source: Depression News From Medical News Today [2009.11.18]
Depressive symptoms improved among women with coronary heart disease who participated in a motivationally-enhanced cardiac rehabilitation program exclusively for women, according to research presented at the American Heart Association's Scientific Sessions 2009. Depression often co-occurs with heart disease and is found more often in women with heart disease than in men.
Telephone-Delivered Care For Treating Depression After CABG Surgery Appears To Improve Outcomes
Source: Depression News From Medical News Today [2009.11.17]
Patients who received telephone-delivered collaborative care for treatment of depression after coronary artery bypass graft surgery reported greater improvement in measures of quality of life, physical functioning and mood than patients who received usual care, according to a study in the November 18 issue of JAMA. The study is being released early online because of its presentation at an American Heart Association scientific conference.
Treating depression after surgery speeds recovery (Reuters)
Source: Y! Health Depression News [2009.11.17]
Reuters - A simple telephone intervention improved mood, physical functioning, and overall quality of life in patients who were depressed after heart bypass surgery, researchers reported in a late breaking clinical trial here at the American Heart Association Scientific Sessions 2009.
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.
Clinical Trials Related to Serzone (Nefazodone)
Nefazodone in the Treatment of Cocaine Dependence and Depression - 4 [Active, not recruiting]
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]
|
PATIENT REVIEWS / RATINGS / COMMENTSBased 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. |
|
|
|
Page last updated: 2009-11-19
|
