EDITED CASE NOTES OF THREE 'PLACEBO SUICIDES'
[Details of patients ages and specific dates have been edited to avoid patient identification. All three cases refer to males aged between 30-40 years]
Patient 627.605.01012
Study medication – placebo
Cause of death – suicide
Case reference number 1999005430-1, is a clinical trial report from blinded study 29060/627 for post-traumatic stress disorder. This report refers to a ... male (patient identification number 627.605.01012).
The patient's medical history includes major depression, social phobia, panic disorder, agarophobia, obsessive compulsive disorder and suicidal ideation (since 1996). Concomitant medications include gliclazide, metformin hydrochloride and captopril.
The patient received oral study medication (placebo dose level 1) [in 1999] ... some 7 days after the first dose, the patient experienced severe depressive symptoms which worsened over the next 2-3 weeks. During this time, the patient experienced extreme post-traumatic stress disorder symptoms, including strong feelings of agitation, social withdrawal and suicidal ideation. (The patient was advised at last visit to seek extensive help, primarily electroconvulsive therapy). The patient was diagnosed as having acute depression. The patient was treated for the event with clotiapine, oxazepam and fluoxetine.
Treatment with study medication was stopped due to the depression on [first day of month] 1999 and the patient was withdrawn from the study. The patient reported to be feeling better and denied having any thoughts of suicide, however, at times, he appeared to be agitated. He was discharged from hospital on 12th [day of month]. On 15th [day of month], the patient underwent electroconvulsive therapy as an out-patient (last treatment of 6) and his condition was reported as much improved. A follow-up visit was scheduled for 19th [day of month]. The investigator considered this to be a serious event because it was life-threatening, disabling, incapacitating and required hospitalisation.
The investigator reported the acute depression to be unrelated to treatment with study medication. The investigator reported that the event could be assoictaed with the patient’s primary condition.
On 18th [day of month], some 17 days after the last dose of study medication, the patient committed suicide by shooting himself. An autopsy was performed by the State Pathologist, but the report was unavailable.
The investigator reported the patient's suicide as unrelated to treatment with study medication. The investigator reported the event could be associated with the patient's primary condition and major depression
Patient 785-721.00716
Study medication – placebo
Cause of death – suicide
This report refers to a ... male (patient identification number 785.721.00716) who participated in double-blind Study 29060/785 for the treatment of major depressive disorder with anxiety.
The patient's medical history included a hemangioma left facial distribution, allergy to pollen and hay fever. The patient had no concomitant medication use.
The patient received study medication [for 41 days during] 2001. 19 days after completing the study and the last dose of study medication, the patient’s brother called to report the patient passed away. A second call from the patient’s brother confirmed the patient committed suicide.
The investigator reported the suicide as not related to treatment with study medication and probably associated with major depressive disorder.
Patient 057.012.4217
Study medication – placebo
Cause of death – suicide
This [patient] attempted suicide by taking 60 x 10mg temazepam capsules on day 29. Later in the study he ate toxic plants as a suicidal gesture (Day 57); be suffered from abdominal pain, nausea and headache (no doubt as a result of this). On days 106 and 113, more than 14 days after the last dose of study medication, the patient made further attempts (toxic seeds and intoxication by motor car gas). Finally, 33 days after completion of the study, he died. His death was considered to be unrelated to trial therapy.
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