Interventions for Acute Depression – Study Characteristics

National Collaborating Centre for Mental Health (UK)

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National Collaborating Centre for Mental Health (UK). Bipolar Disorder: The NICE Guideline on the Assessment and Management of Bipolar Disorder in Adults, Children and Young People in Primary and Secondary Care. London: The British Psychological Society and The Royal College of Psychiatrists; 2014 Sep. (NICE Clinical Guidelines, No. 185.)

See 2018 Partial Update

April 2018: Footnotes and cautions have been added and amended to link to the MHRA's latest advice and resources on sodium valproate. Sodium valproate must not be used in pregnancy, and only used in girls and women when there is no alternative and a pregnancy prevention plan is in place. This is because of the risk of malformations and developmental abnormalities in the baby. November 2017: Footnotes for some recommendations were updated with current UK marketing authorisations and MHRA advice. Links to other guidelines have also been updated. Some research recommendations have been stood down. See these changes in the short version of the guideline.

April 2018: Footnotes and cautions have been added and amended to link to the MHRA's latest advice and resources on sodium valproate. Sodium valproate must not be used in pregnancy, and only used in girls and women when there is no alternative and a pregnancy prevention plan is in place. This is because of the risk of malformations and developmental abnormalities in the baby. November 2017: Footnotes for some recommendations were updated with current UK marketing authorisations and MHRA advice. Links to other guidelines have also been updated. Some research recommendations have been stood down. See these changes in the short version of the guideline.

Bipolar Disorder: The NICE Guideline on the Assessment and Management of Bipolar Disorder in Adults, Children and Young People in Primary and Secondary Care.

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APPENDIX 16Interventions for Acute Depression – Study Characteristics

Abbreviations

AUS: Australia
BPI: bipolar I disorder
CHN: China
Dur: duration
ESP: Spain
FRA: France
Freq: frequency
GBR: Great Britain
GER: Germany
IND: India
JPN: Japan
KOR: Korea
N: number of participants
N/A: not applicable
N Post: number of participants at post-treatment
NR: not reported
N Rand: number of participants randomised
NLD: Netherlands
POL: Poland
ROU: Romania
RUS: Russia
RSA: Republic of South Africa
TAU: treatment as usual
TMS: transcranial magnetic stimulation
TWN: Taiwan
UKR: Ukraine
USA: United States of America
XR: extended release

1.1. Pharmacological Interventions

Study	Country	Age	% Female	% BPI	Concomitant medication	N Rand	N Post	Group	Dose	Freq	Dur
Aripiprazole compared with placebo
BRISTOLMYERSSQUIB2006	USA	39	63%	100%	None	186	162	Aripiprazole	10 mg	14	8
BRISTOLMYERSSQUIB2006	USA	39	63%	100%	None	188	177	Placebo	N/A	14	8
BRISTOLMYERSSQUIB2007	USA	40	60%	100%	None	187	175	Aripiprazole	10 mg	14	8
BRISTOLMYERSSQUIB2007	USA	40	60%	100%	None	188	176	Placebo	N/A	14	8
QUANTE2010	GER	51	48%	74%	Citalopram with lithium or valproate	12	8	Aripiprazole	15 mg	7	6
QUANTE2010	GER	51	48%	74%	Citalopram with lithium or valproate	11	10	Placebo	N/A	7	6
Bupropion, sertraline and venlafaxine
POST2006	USA, NLD, GER	42	50%	73%	Mood stabiliser and/or an antipsychotic	51	51	Bupropion	280 mg	7	10
						58	58	Setraline	190 mg	7	10
						65	65	Venlafaxine	195 mg	7	10
Imipramine compared with moclobemide
SILVERSTONE2001	USA	37	100%	0%	Mood stabilisers, single benzodiazepine hypnotic	75	75	Imipramine	150 mg	7	8
SILVERSTONE2001	USA	37	100%	0%	Mood stabilisers, single benzodiazepine hypnotic	81	81	Moclobemide	600 mg	7	8
Lamotrigine compared with placebo
CALABRESE1999	USA, GBR, FRA, AUS	41	60%	100%	None	66	64	Lamotrigine	50 mg	14	7
						63	63	Lamotrigine	200 mg	14	7
						66	65	Placebo	Placebo	14	7
CALABRESE2005	USA, GBR, FRA, AUS	41	60%	100%	Benzodiazepines (limited use)	181	NR	Quetiapine	300 mg	7	8
						180	NR	Quetiapine	600 mg	7	8
						181	NR	Placebo	N/A	7	8
CALABRESE2008a	USA	41	62%	NR	NR	103	102	Lamotrigine	200 mg	7	10
CALABRESE2008a	USA	41	62%	NR	NR	103	100	Placebo	N/A	7	10
CALABRESE2008b	USA	37	55%	100%	NR	133	126	Lamotrigine	200 mg	7	8
CALABRESE2008b	USA	37	55%	100%	NR	124	117	Placebo	N/A	7	8
CALABRESE2008c	USA	37	64%	0%	NR	111	109	Lamotrigine	200 mg	7	8
CALABRESE2008c	USA	37	64%	0%	NR	110	105	Placebo	N/A	7	8
CALABRESE2008d	USA	38	54%	100%	NR	131	123	Lamotrigine	200 mg	7	8
CALABRESE2008d	USA	38	54%	100%	NR	128	120	Placebo	N/A	7	8
VANDERLOOS2009	NLD, ESP	46	54%	68%	Lithium	64	64	Lamotrigine	200 mg	7	8
VANDERLOOS2009	NLD, ESP	46	54%	68%	Lithium	60	60	Placebo	N/A	7	8
Lamotrigine, gabapentin and placebo
FRYE2000	USA	NR	58%	35%	Levothyroxine, triiodothyronine and clonazepam allowed in phase I	NR	NR	Lamotrigine	300 mg	7	6
						NR	NR	Gabapentin	3,980 mg	7	6
						NR	NR	Placebo	N/A	7	6
Lurasidone compared with placebo
SUNOVION2012a	GER, IND, POL, ROU, RUS, RSA, UKR, USA	42	48%	100%	Lithium or valproate allowed	183	179	Lurasidone	65 mg	7	6
SUNOVION2012a	GER, IND, POL, ROU, RUS, RSA, UKR, USA	42	48%	100%	Lithium or valproate allowed	165	161	Placebo	N/A	7	6
SUNOVION2012b	USA, GBR, FRA, AUS	41	60%	100%	Lithium or valproate allowed	166	161	Lurasidone	32 mg	7	6
						169	162	Lurasidone	80 mg	7	6
						170	162	Placebo	N/A	7	6
Olanzapine compared with placebo
TOHEN2012	JPN, CHN, TWN, KOR, USA	36	58%	100%	NR	343	343	Olanzapine	10 mg	7	6
TOHEN2012	JPN, CHN, TWN, KOR, USA	36	58%	100%	NR	171	171	Placebo	N/A	7	6
Olanzapine and fluoxetine combination compared with lamotrigine
BROWN2006	USA	37	60%	100%	Anticholinergics, benzodiazepines or other hypnotics allowed	205	202	Olanzapine and fluoxetine	10.7 mg/40.8 mg	7	7
BROWN2006	USA	37	60%	100%		205	191	Lamotrigine	106.4 mg	7	7
Olanzapine and fluoxetine combination, olanzapine and placebo
TOHEN2003	USA	37	57%	67%	Lorazepam and anticholinergic therapy	86	82	Olanzapine and fluoxetine	7.4 mg/39.3 mg	7	8
						370	351	Olanzapine	9.7 mg	7	8
						377	355	Placebo	N/A	7	8
Paroxetine, imipramine and placebo
NEMEROFF2001	USA	36	NR	70%	Lithium, valproate and/or carbamazepine	35	33	Paroxetine	32.6 mg	7	10
						39	36	Imipramine	166.7 mg	7	10
						43	43	Placebo	N/A	7	10
Quetiapine compared with placebo
SUPPES2010	USA	39	65%	80%	Lorazepam, zolpidem tartrate, zaleplon, zopiclone, chloral hydrate and anticholinergics allowed	140	133	Quetiapine XR	300 mg	7	8
SUPPES2010	USA	39	65%	80%		130	137	Placebo	N/A	7	8
THASE2006	USA	37	57%	67%	Lorazepam and zolpidem tartrate allowed	172	155	Quetiapine	300 mg	7	8
						169	151	Quetiapine	600 mg	7	8
						168	161	Placebo	N/A	7	8
Quetiapine compared with paroxetine
MCELROY2010	Multiple (not specified)	42	59%	62%	Lorazepam, zolpidem tartrate and chloral hydrate allowed	245	229	Quetiapine	300 mg	7	8
						247	232	Quetiapine	600 mg	7	8
						122	118	Paroxetine	20 mg	7	8
						126	121	Placebo	N/A	7	8
Quetiapine, lithium and placebo
YOUNG2010	Multiple (not specified)	42	59%	62%	Lorazepam, zolpiclone tartrate, zaleplon, zopliclone and chloral hydrate allowed	265	255	Quetiapine	300 mg	7	8
						268	263	Quetiapine	600 mg	7	8
						136	136	Lithium	490.5 mg	7	8
						133	129	Placebo	N/A	7	8
Valproate compared with placebo
DAVIS2005	USA	41	11%	100%	Bedtime sedatives allowed	13	13	Valproate	1,250 mg	7	8
DAVIS2005	USA	41	11%	100%	Bedtime sedatives allowed	12	12	Placebo	N/A	7	8
GHAEMI2007	USA	37	50%	50%	None	10	9	Valproate	1,028.8 mg	7	6
GHAEMI2007	USA	37	50%	50%	None	8	9	Placebo	N/A	7	6
MUZINA2011	USA	39	57%	37%	Lorazepam and zolpidem allowed	26	26	Valproate	1,606 mg	7	6
MUZINA2011	USA	39	57%	37%	Lorazepam and zolpidem allowed	28	28	Placebo	N/A	7	6
Ziprasidone compared with placebo
PAKAR2012	USA	39	53%	40%	Treatment as usual	NR	NR	Ziprasidone	80–160 mg	7	6
PAKAR2012	USA	39	53%	40%	Treatment as usual	NR	NR	Placebo	N/A	7	6
PFIZER2009a	USA	20	57%	100%	None	185	NR	Ziprasidone	40 mg	14	6
PFIZER2009a	USA	20	57%	100%	None	196	NR	Placebo	N/A	14	6
PFIZER2009b	USA, GBR, FRA, AUS	41	60%	100%	None	171	NR	Ziprasidone	20 mg	14	6
						165	NR	Ziprasidone	40 mg	14	6
						168	NR	Placebo	N/A	14	6
SACHS2011	AUS, IND, USA	40	61%	100%	Lamotrigine, lithium or valproate; lorazepam allowed	148	147	Ziprasidone	40 mg	14	6
SACHS2011	AUS, IND, USA	40	61%	100%	Lamotrigine, lithium or valproate; lorazepam allowed	150	147	Placebo	N/A	14	6

1.2. Nutritional Interventions

Nutritional interventions
Omega-3 fatty acids compared with placebo
KECK2006B	NR	45	48%	74%	Mood stabilisers	59	NR	Eicosapentaenoic acid	6,000 mg	7	17
KECK2006B	NR	45	48%	74%	Mood stabilisers	57	NR	Placebo	N/A	7	17

1.3. Physical Interventions

Physical interventions
Acupuncture compared with sham acupuncture
DENNEHY2009B	USA	41	69%	38%	Medication as usual	13	NR	Acupuncture	N/A	1.5	8
DENNEHY2009B	USA	41	69%	38%	Medication as usual	13	NR	Sham	N/A	1.5	8
Bright light therapy compared with low-density and high density air ionization
DAUPHINAIS2012	USA	43	74%	NR	Medication as usual	18	10	Bright light therapy	N/A	7	8
						20	11	Low-density negative air ionization	N/A	7	8
						6	2	Highdensity negative air ionization	N/A	7	8
Chronotherapeutic augmentation treatment compared with treatment as usual (TAU)
WU2009	USA	39	41%	NR	Lithium and antidepressants	32	32	Sleep deprivation, bright light therapy and sleep phase advance	N/A	1	7
WU2009	USA	39	41%	NR	Lithium and antidepressants	17	17	TAU	N/A	1	7
Transcranial magnetic stimulation (TMS) compared with sham TMS
NAHAS2003	USA	43	61%	61%	Carbamazepine, valproate or combination	11	11	TMS	20 minutes	7	2
NAHAS2003	USA	43	61%	61%	Carbamazepine, valproate or combination	12	12	Sham TMS	20 minutes	7	2

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Bookshelf ID: NBK545948

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National Collaborating Centre for Mental Health (UK). Bipolar Disorder: The NICE Guideline on the Assessment and Management of Bipolar Disorder in Adults, Children and Young People in Primary and Secondary Care. London: The British Psychological Society and The Royal College of Psychiatrists; 2014 Sep. (NICE Clinical Guidelines, No. 185.) APPENDIX 16, Interventions for Acute Depression – Study Characteristics.
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