Suicidality and divalproex sodium: analysis of controlled studies in multiple indications

Redden, Laura; Pritchett, Yili; Robieson, Weining; Kovacs, Xenia; Garofalo, Mary; Tracy, Katherine; Saltarelli, Mario

doi:10.1186/1744-859X-10-1

Annals of General Psychiatry

Table 4 Characteristics of suicidality events

From: Suicidality and divalproex sodium: analysis of controlled studies in multiple indications

Study	Treatment	Event, study day(s)	Age, years	Gender	Adverse event term(s)	Relevant history
Completed suicide: 0
Suicide attempts: 4
Mania maintenance	DVPX	241	21	Female	Overdose, suicide attempt	Benzodiazepine overdose after a family conflict. Family history of bipolar disorder; history of previous SA.
Mania maintenance	DVPX	313	43	Female	Manic depressive reaction, overdose, suicide attempt	Benzodiazepine overdose. Family history of alcoholism, ADHD; previous SA approximately 12 months prior; SADS-C suicidal tendency score was 1 (not at all) on day 308.
Mania maintenance	Placebo	71	29	Female	Overdose	Benzodiazepine + alcohol combination 'due to poor judgment'. Marital break-up and lost custody of children. Family history of anxiety, depression.
Bipolar depression^a	Placebo	19	18	Male	Euphoria, abdominal pain, overdose	Amphetamine overdose. One SA in past year; mother died in past year; HAM-D rated as 0 (absent) and BPRS rated as 0 (not present) on day 15.
Preparatory acts toward imminent suicidal behavior: 1
Mania maintenance	Placebo	29	26	Female	Depression	Severe depression and suicidal ideation 1 day post treatment. Family history of mood, eating, and drug abuse disorders; history of borderline personality disorder; five SA since 1983 (last approximately 1 year prior); SADS-C rated as 1 (not at all) on day -1, 2 (slight) on day 7 and 5 (severe) on day 29.
Suicidal ideation: 15^b
Epilepsy, adjunctive CPS	DVPX	19	21	Female	Depression	Severe thoughts of suicide that resolved the next day. History of drug abuse (approximately 1 year recovered), violent during seizures, and decreased mental sharpness; CBZ.
Acute mania	DVPX	2	33	Female	Depression	Moderate suicidal thoughts lasting 6 hours after a 'family event'. SADS-C rated as 0 (not at all) on day -1 and day 5.
Mania maintenance	DVPX	24	52	Male	Depression	Moderate suicidal ideation. Family history of suicide, abuse, electroconvulsive therapy, and residing in mental institution; history of obesity, diabetes, cardiovascular disease; SADS-C rated as 2 (slight) on day 15 and 4 (moderate) on day 30.
Mania maintenance	DVPX	23	31	Female	Depression	Severe depression, BDI indicated suicidal ideation. Family history of mood swings; SADS-C rated as 1 (not at all) on days -1 and 7, and 5 (severe) on day 24.
Mania maintenance	DVPX	196	22	Male	Depression	Severe depression and suicidal ideation. SADS-C rated as 3 (mild) on day 1.
Mania maintenance	DVPX	1	28	Male	Thinking abnormal thoughts	Moderate fleeting thoughts of wanting to hurt self (non-suicidal). SADS-C rated as 1 (not at all) on day -1, and 2 (slight) on day 18.
Mania maintenance	DVPX	44, 234	45	Male	Depression	Two episodes of suicidal ideation (severe and mild, respectively). Family history of depression; SADS-C rated as 6 (extreme) on day 55 and 3 on day 218; paroxetine.
Impulsive aggression	DVPX	16	37	Male	Depression	Severe hostility, depression and suicidal ideation, 'stress due to friend's death'. History of major depression, HIV positive (3 months), childhood physical abuse, possible PTSD; HAM-D rated as 1 (life not worth living) on day -22.
Impulsive aggression	DVPX	38	36	Female	Depression	Moderate feelings of worthlessness and hopelessness, mild thoughts of suicide. History of intermittent explosive disorder, alcohol dependence, cluster B personality disorder-borderline; HAM-D was rated as 0 (absent) on days 28 and 48.
Mania maintenance	Placebo	54	31	Male	Depression	Severe suicidal ideation and intent. Family history of depression; history of panic attacks; SADS-C rated as 3 (mild) on day 43 and 6 (extreme) on day 54; thyrosin, sertraline.
Mania maintenance	Placebo	188	45	Female	Manic depressive reaction	Severe suicidal ideation. Family history of bipolar disorder, depression; SADS-C rated as 1 (not at all) on day 175 and 5 (severe) on day 188.
Mania maintenance	Placebo	116	41	Female	Manic depressive reaction	Severe suicidal ideation and psychosis; SADS-C rated as 1 (not at all) on day 111 and 4 (moderate) on day 116.
Mania maintenance	Placebo	131	38	Male	Depression	Mild and transient suicidal ideation after ethanol consumption. Family history of bipolar disorder; SADS-C rated as 2 (slight) on day 115.
Mania maintenance	Placebo	39	32	Female	Psychotic depression	Severe depression and suicidal ideation. Family history of depression; SADS-C rated as 3 (mild) on day 28.
Impulsive aggression	Placebo	20	31	Female	Depression	Mild suicidal ideation with no plans/means that resolved within 2 hours. History of major depression, physical abuse, witnessed domestic violence, borderline cluster B personality disorder; HAM-D rated as 0 (absent) on day -15 and 28.
Epilepsy, monotherapy	Low-dose DVPX	17	33	Female	Depression	Moderate depression and thoughts of suicide. Marital and financial issues; history of anxiety, CBZ.

^aThis subject also experienced an event of suicidal ideation (code 4) on day 17; only the most severe event is included in this table.
^bN = 15 in placebo-controlled studies when counting the most severe event in patients experiencing >1 event.
ADHD = attention-deficit hyperactivity disorder; BDI = Beck Depression Inventory; BPRS = Brief Psychiatric Rating Scale suicidal thoughts; CBZ = carbamazepine; CPS = complex partial seizures; DVPX = divalproex sodium; HAM-D = Hamilton Depression Rating Scale suicide score; PTSD = post-traumatic-stress disorder; SA = suicide attempt; SADS-C = Schedule for Affective Disorders and Schizophrenia-Change Version suicidal tendency score.

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ISSN: 1744-859X

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