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Lawrenceville, NJ (Dr Simone) – Psychiatric disorders account for almost 25% of the world’s diseases and the most common disorder is depression.  The US FDA has approved the use of antidepressants mainly for major depressive disorder but they are widely prescribed “off-label” inappropriately for mild and moderate depression as well as many other psychiatric disorders. And largely withheld from the medical community and the public, antidepressants can induce violent behavior.  In fact, “IN 90% OF ALL SCHOOL SHOOTINGS, THE SHOOTERS EITHER WERE ON OR HAD TAKEN PSYCHOTROPIC DRUGS” THAT CAN INDUCE VIOLENCE. 



Data submitted to FDA show that antidepressants are ineffective in children and teenagers (mean age 9-18 years) and adults.  Even in the most severe cases of major depression for which antidepressants are actually approved, they were not effective compared to placebo.  Antidepressants are approved for patients 18 and older.  But they are inappropriately prescribed “off-label” to children and teenagers and for conditions that are not approved.


One large meta-analysis study used data that were submitted to FDA.  Published reports claimed positive results even though “negative” trials were either left unpublished or were distorted to present “positive” results.  The average benefit of these drugs was small, while the published literature suggested larger benefits.

Turner EH et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Eng J Med. 2008. 358 (3): 252-60.  http://www.nejm.org/doi/full/10.1056/NEJMsa065779.

A second large meta-analysis also used FDA-submitted data.  Even in the most severe cases of major depression, antidepressants were not effective compared to placebo.  These studies included many small randomized trials with clinically non-relevant outcomes, improper interpretation of statistical significance, manipulated study design, biased selection of study populations, and short follow-up (often less than 8 weeks).

Kirsch I, et al. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the FDA.  PLos Med. 2008, 5(2): e45.  http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0050045 ].   

Ioannidis JPEffectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?  Philos Ethics Humanit Med. 2008 May 27;3:14. doi: 10.1186/1747-5341-3-14.


Antidepressants are ineffective in children and teenagers (mean age 9-18 years) with major depression as shown in 34 published and unpublished randomized trials published from 1986 to 2014 looking at the effects of 14 antidepressants in a total of 5,260 participants. 



“Child and adolescent Psychiatry, as an established Medical Specialization, risks permanent extinction, since most of its pharmaceutical armamentarium, prescribed for a variety of common mental conditions, proved ineffective, or even harmful.

Dr. Stavros Saripanidis, Thessaloniki, Greece 14 June 2016  https://www.bmj.com/content/353/bmj.i3234/rr   


A study from Copenhagen involved the analysis of 131 randomized controlled trials with a total of 27,422 participants.  The authors found that every study had a high risk of bias in study design and publication, the clinical significance was questionable, and the antidepressants increased the risk of suicidal thoughts and aggressive behavior doubled in children and adolescents who used these drugs.  Suicidal thinking was passed off as “emotional lability” or “worsening depression” and this information was buried in appendices that were available for less than half of the trials. The FDA never requested the rest of the appendices.  For trials that examined mild to moderate depression, neither a doctor nor the patient would notice any change with medication.

Jakobsen JC, et al. BMC Psychiatry. 2017. 17:58  https://doi.org/10.1186/s12888-016-1173-2

The benefit of antidepressant medications “may be minimal or nonexistent, on average, in patients with mild or moderate symptoms.”

Fournier JC, et al.  JAMA. 2010 Jan 6;303(1):47-53. doi: 10.1001/jama.2009.1943.  

In 2004 the FDA gave antidepressants a black box warning because even then it was known they cause suicide ideation. The European Medicines Agency has issued similar alerts. But studies have demonstrated violent behavior from antidepressants and other psychotropic drugs.

Big Pharma has promoted a myth that antidepressants are effective by using the same playbook – get published, hire “thought leader” doctors to tell other doctors to prescribe and get those drugs into pharmacies. 


FDA SHOULD REMOVE DRUGS THAT INDUCE VIOLENCE AND ARE NOT EFFECTIVE because their mission is “to protect the public health by ensuring the safety, efficacy, and security of human….drugs…” 

These drugs are not safe and they are not effective. 

And until they are removed, doctors should not prescribe them.


(c) 2018 Charles B. Simone, M.MS., M.D.