APPENDIX IV: Narratives: Definitive Suicidal Behavior Events: MDD
The case narratives contained herein reflect subjects with major depressive disorder with
either definitive suicidal behavior or rating scale emergent suicidal behavior. The case
narratives are in the order presented in Table 2.11 of Appendix II.
Serious Adverse event Preferred term(s):
Serious Adverse event Verbatim term(s): Suicide Gesture by Suffocation
This patient is a 67-year-old white female with a diagnosis of major depressive disorder,
recurrent with melancholia (DSM-III: 296.3). She has no significant medical history. She
received chloral hydrate 500 mg/day (6/12-16185) for severe insomnia and FI0RINA
(butalbital) 2 tablets/day (6/12-13/85) for headache.
Screen ECG was an abnormal record which could have reflected recent change. Further
ECG showed that lead V-2 was technically unsatisfactory, but there was no change from
screen. Left ventricular hypertrophy could have been responsible for the reading wholly
or in part. No other clinical information is available.
The patient began placebo on 6/19186 and continued treatment until 6/25/85, when she
made a suicide gesture by suffocation. Her husband prevented her suicide, she was
brought to the investigator that same day, and her termination visit was completed. She
was dropped for lack of efficacy because of the profound and rapid deterioration of her
condition prior to her suicide attempt. No laboratory abnormalities were recorded and she
reported no adverse clinical experiences. Post-study follow-up visit on 6/26/85 revealed
her condition continued to deteriorate. She reported no withdrawal effects.
This 67-year-old female was enrolled in a double-blind clinical study for the treatment of
major depressive disorder. At the time of study entry, the patient had a diagnosis of
major depression, with melancholia (DSM-III: 296.33).