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Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and 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. Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)
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ZOLOFT SUMMARY
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
ZOLOFT® (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral administration.
ZOLOFT is indicated for the following:
Major Depressive Disorder- ZOLOFT® (sertraline hydrochloride) is indicated for the treatment of major depressive disorder.
Obsessive-Compulsive Disorder- ZOLOFT is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD).
Panic Disorder- ZOLOFT is indicated for the treatment of panic disorder, with or without agoraphobia.
Posttraumatic Stress Disorder (PTSD)- ZOLOFT (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder.
Premenstrual Dysphoric Disorder (PMDD) - ZOLOFT is indicated for the treatment of premenstrual dysphoric disorder (PMDD).
Social Anxiety Disorder - ZOLOFT (sertraline hydrochloride) is indicated for the treatment of social anxiety disorder, also known as social phobia.
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ZOLOFT NEWS HIGHLIGHTS
Published Studies Related to Zoloft (Sertraline)
Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. [2008.12.25]
BACKGROUND: Anxiety disorders are common psychiatric conditions affecting children and adolescents. Although cognitive behavioral therapy and selective serotonin-reuptake inhibitors have shown efficacy in treating these disorders, little is known about their relative or combined efficacy... CONCLUSIONS: Both cognitive behavioral therapy and sertraline [generic for Zoloft] reduced the severity of anxiety in children with anxiety disorders; a combination of the two therapies had a superior response rate. (ClinicalTrials.gov number, NCT00052078.) 2008 Massachusetts Medical Society
Cognitive Behavioral Therapy, Sertraline, or a Combination in Childhood Anxiety. [2008.10.30]
BACKGROUND: Anxiety disorders are common psychiatric conditions affecting children and adolescents. Although cognitive behavioral therapy and selective serotonin-reuptake inhibitors have shown efficacy in treating these disorders, little is known about their relative or combined efficacy... CONCLUSIONS: Both cognitive behavioral therapy and sertraline [generic for Zoloft] reduced the severity of anxiety in children with anxiety disorders; a combination of the two therapies had a superior response rate. (ClinicalTrials.gov number, NCT00052078.) Copyright 2008 Massachusetts Medical Society.
Safety and efficacy of sertraline for depression in patients with CHF (SADHART-CHF): a randomized, double-blind, placebo-controlled trial of sertraline for major depression with congestive heart failure. [2008.09]
CONCLUSION: Because of the high prevalence of depression and its significant adverse impact on prognosis of patients with ischemic heart disease (IHD) and HF, the Safety and Efficacy of Sertraline [generic for Zoloft] for Depression in Patients with Chronic Heart Failure (SADHART-CHF) trial aims to assess the effects of sertraline on response of depression as well as on the cardiac prognosis of patients with HF.
Naltrexone alone and with sertraline for the treatment of alcohol dependence in Alaska natives and non-natives residing in rural settings: a randomized controlled trial. [2008.07]
BACKGROUND: Access to specialty alcoholism treatment in rural environments is limited and new treatment approaches are needed. The objective was to evaluate the efficacy of naltrexone alone and in combination with sertraline [generic for Zoloft] among Alaska Natives and other Alaskans living in rural settings. An exploratory aim examined whether the Asn40Asp polymorphism of the mu-opioid receptor gene (OPRM1) predicted response to naltrexone, as had been reported in Caucasians... CONCLUSIONS: Naltrexone can be used effectively to treat alcoholism in remote and rural communities, with evidence of benefit for American Indians and Alaska Natives. New models of care incorporating pharmacotherapy could reduce important health disparities related to alcoholism.
Variable dosing of sertraline for premenstrual exacerbation of depression: a pilot study. [2008.07]
OBJECTIVES: Premenstrual exacerbation of depression (PMED) is a variation of major depressive disorder (MDD) in which symptoms worsen during the premenstrual period. Breakthrough symptoms of PMED may occur despite effective antidepressant treatment in the rest of the cycle. This pilot study is designed to evaluate the effectiveness of variable dosing in PMED using the antidepressant sertraline [generic for Zoloft]... CONCLUSIONS: The use of variable dosing in PMED increases the effectiveness of treatment.
Clinical Trials Related to Zoloft (Sertraline)
A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression. [Completed]
This study was designed to determine if the novel combination of the SSRI, sertraline, and
the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable
safety profile of SSRIs.
A Research Study to Compare the Treatments of a Combination of Elzasonan With Zoloft, to Zoloft Alone, or Placebo in People With Major Depressive Disorder (MDD) [Completed]
The major purpose of the study is to help determine whether giving the combination of
Elzasonan with Zoloft to people with depression is a better treatment than taking Zoloft
alone. This study will also compare the safety and tolerability of Elzasonan and Zoloft
combination to Zoloft alone or placebo.
Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's sertraline
hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100
mg (1 x 100 mg) dose administered under fasting conditions.
Special Investigation of Long Term Use of Sertraline [Enrolling by invitation]
Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety.
The objective of this "Special investigation" is to collect information about 1) adverse drug
reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of
adverse drug reactions in this surveillance, and 3) factors considered to affect the safety
and/or efficacy of this drug regarding to long time use.
Food Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's sertraline
hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100
mg (1 x 100 mg) dose administration under fed conditions.
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ZOLOFT PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 41 ratings/reviews, Zoloft has an overall score of 7.37. The effectiveness score is 7.85 and the side effect score is 7.66. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Zoloft review by 42 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | anxiety |
| Dosage & duration: | | 10mg taken 1 time daily for the period of 1 year |
| Other conditions: | | associated with anxiety |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | becoming a normal functioning individual. it helped with the worry or feelings of anxiety. when diriving not being overwhelmed and felling confident. able to go in stores and be around people. not feeling tired or other types of side effects associated with anxiety drugs. not addictive, unlike other drugs. eventually i was able to stop taking the drug for a full recovery |
| Side effects: | | I had no real side effects unless you consider lack of fear or worry one. |
| Comments: | | taken once daily. |
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| | Zoloft review by 56 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | head injuries |
| Dosage & duration: | | 200 mg taken once per day for the period of 12 years |
| Other conditions: | | depression |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Due to a car accident I sustained head injuries in addition to physical body injuries (broken bones, etc.) I had terrible mood swings. Through the assistance of a Psycharist subscribing Zoloft, gradually I became calmer. I didn't cry as often for no apparent reason or get irritated at the drop of a hat. My short term memory returned and I became less self conscious. |
| Side effects: | | Sometimes I experienced a slight ticking in my head as if I had something in my brain clicking all the time. If I do not take the Zoloft when I get up (later in the day) I get headachs. No other side effects. |
| Comments: | | Initial dosage was 50 mg gradually over two year my span dosage increased to 200 mg. I still am taking Zoloft. I am somewhat fraid my symptoms will resurface. I am also concerned about any withdrawals or headachs. |
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| | Zoloft review by 50 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 50 mg taken once a day for the period of Two months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Patient experienced no treatment benefits. |
| Side effects: | | The major side effect was persistent thoughts of suicide - always by hanging. These thoughts developed after about three weeks of treatment and became more persistent as time went on. Patient stopped taking the medication after two months subsequently informing attending physician, who initially did not believe that medication could provoke that side effect in someone 50 years of age. |
| Comments: | | Treatment details are as described above. |
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Page last updated: 2009-02-08
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