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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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NEWS HIGHLIGHTS
Published Studies Related to Zoloft (Sertraline)
A double-blind randomized controlled trial of olanzapine plus sertraline vs olanzapine plus placebo for psychotic depression: the study of pharmacotherapy of psychotic depression (STOP-PD). [2009.08]
CONTEXT: Evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients with major depression (MD) with psychotic features. OBJECTIVES: To compare remission rates of MD with psychotic features in those treated with a combination of atypical antipsychotic medication plus a serotonin reuptake inhibitor with those treated with antipsychotic monotherapy; and to compare response by age... CONCLUSIONS: Combination pharmacotherapy is efficacious for the treatment of MD with psychotic features. Future research must determine the benefits vs risks of continuing atypical antipsychotic medications beyond 12 weeks. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00056472.
Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study. [2009.06]
We investigated safety and efficacy of vardenafil and sertraline in premature ejaculation (PE). Seventy-two men graded their primary PE on a scale of 0-8 (0 = almost never, 8 = almost always)...
A pooled analysis of suicidality in double-blind, placebo-controlled studies of sertraline in adults. [2009.05]
CONCLUSION: Results of short-term, all-duration, and psychiatric studies analyses, as well as age-group analyses, performed in accordance with the FDA-specified search strategy, show no significant increase in suicidality risk in adult sertraline- versus placebo-treated patients. Copyright 2009 Physicians Postgraduate Press, Inc.
Time to relapse after short- or long-term treatment of severe premenstrual syndrome with sertraline. [2009.05]
CONTEXT: The duration of treatment after achieving a satisfactory response is unknown in the treatment of premenstrual syndrome. This information is needed in view of the improvement provided by medication vs the adverse effects and costs of drugs. OBJECTIVE: To compare rates of relapse and time to relapse between short- and long-term treatment with sertraline hydrochloride administered in the luteal phase of the menstrual cycle... CONCLUSIONS: The relapse rate was significantly greater after short-term treatment compared with long-term treatment. The relapse rate was also high during extended drug treatment. Subjects with severe symptoms at baseline were most likely to experience relapse, and relapse occurred more swiftly regardless of treatment duration. These findings suggest that the severity of symptoms at baseline and symptom remission with treatment should be considered in determining the duration of treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00318773.
A randomized controlled trial of sertraline for the treatment of depression in persons with traumatic brain injury. [2009.05]
OBJECTIVE: To examine the efficacy of sertraline in the treatment of depression after traumatic brain injury (TBI)... CONCLUSIONS: Both groups showed improvements in mood, anxiety, and QOL, with 59% of the experimental group and 32% of the placebo group responding to the treatment, defined as a reduction of a person's HAM-D score by 50%.
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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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 48 ratings/reviews, Zoloft has an overall score of 7.48. The effectiveness score is 7.96 and the side effect score is 7.79. 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 45 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | anxiety |
| Dosage & duration: | | 50 mg /day taken 1x day for the period of 4 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Completely eliminated anxiety disorder characterized by panic attacks and generalized anxiety after dosage of 50 mg/day was taken. Downsside was that while on 25 mg/day start up dose for the first 7 days anxiety was extremely worsened and almost unbearable. |
| Side effects: | | Initial weight loss |
| Comments: | | Patient taking 50 mg/day for generalized anxiety disorder and panic attacks. Initial start up dose 25 mg/day for 7 days. Anxiety extremely heightened and patient almost disscontinued med because of it. Hung in there and pill started to decrease and finally eliminate anxiety. |
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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 34 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 1 pill a day taken every day for the period of 45 days |
| Other conditions: | | IBS |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I had no benefits. It didn't seem to make anything better at the time. It seemed the depression was still the same and then I had side effects that affected me daily. |
| Side effects: | | I suffered from daily Headaches and also slight nausea every once in awhile. I also felt very dried out and thirsty. It also affected me by lowering my libido. |
| Comments: | | I was supposed to take a pill every morning with water. I felt better once I stopped taking the pills and actually just started working on myself and my goals and then also wehn I started doing volunteer work to help children. |
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Page last updated: 2009-10-20
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