Interventions for Long-Term Management – 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 19Interventions for Long-Term Management – Study Characteristics

Abbreviations

AUS: Australia
AUT: Austria
BEL: Belgium
BUL: Bulgaria
BPI: bipolar I disorder
CAN: Canada
CZE: Czech Republic
BRA: Brazil
DEN: Denmark
Dur: duration
ESP: Spain
FRA: France
Freq: frequency
GBR: Great Britain
GER: Germany
GRE: Greece
HUN: Hungary
CRO: Croatia
IND: India
ITA: Italy
MAS: Malaysia
N/A: not applicable
NED: the Netherlands
NOR: Norway
N Post: number of participants at post-treatment
NR: not reported
N Rand: number of participants randomised
NZL: New Zealand
POL: Poland
RSA: Republic of South Africa
TUR: Turkey
TWN: Taiwan
RUS: Russia
SVK: Slovakia
SWE: Sweden
UKR: Ukraine
USA: United States of America

1.1. Pharmacological Interventions

Study	Country	Age	% Female	% BPI	Concomitant medication	N Rand	N Post	Group	Dose	Freq	Dur
Lithium
Lithium at different doses
GELENBERG1989	USA	39	50%	100%	None	47	47	Lithium	1,400 mg	7	52
GELENBERG1989	USA	39	50%	100%	None	47	47	Lithium	900 mg	7	52
JENSEN1995	DEN	59	58%	86%	Additional antipsychotics or antidepressants. Hypnotics allowed	25	25	Lithium	800 mg	7	65
JENSEN1995	DEN	59	58%	86%		25	25	Lithium	1,200 mg	3.5	48
Lithium compared with placebo
DUNNER1976	USA	51	58%	0%	Amitriptyline or imipramine for depression and chlorpromazine for mania	16	16	Lithium	0.8-1.2mEq/L	7	69
DUNNER1976	USA	51	58%	0%		24	24	Placebo	N/A	7	69
STALLONE1973	USA	51	52%	100%	Amitriptyline or imipramine for depression and chlorpromazine for mania	25	25	Lithium	900 mg	7	121
STALLONE1973	USA	51	52%	100%		27	27	Placebo	N/A	7	121
PRIEN1973	USA	44	35%	NR	None	101	NR	Lithium	1000 mg	7	104
PRIEN1973	USA	44	35%	NR	None	104	NR	Placebo	N/A	7	104
Lithium compared with carbamazepine
COXHEAD1992	GBR	48	71%	NR	Temazepam only	16	NR	Lithium	400 mg	14	52
COXHEAD1992	GBR	48	71%	NR	Temazepam only	15	NR	Carbamazepine	200 mg	14	52
HARTONG2003	NED	42	54%	76%	Benzodiazepines only	72	50	Lithium	800 mg	7	104
HARTONG2003	NED	42	54%	76%	Benzodiazepines only	72	44	Carbamazepine	400 mg	7	104
KLEINDIENST2000	GER	40	56%	100%	Psychotropic comedication	58	NR	Lithium	26.8 mmol	7	130
KLEINDIENST2000	GER	40	56%	100%	Psychotropic comedication	56	NR	Carbamazepine	635 mg	7	130
WOLF1997	HUN	44	64%	NR	Short-time hypnotics	84	84	Lithium	NR	7	52
WOLF1997	HUN	44	64%	NR	Short-time hypnotics	84	84	Carbamazepine	NR	7	52
Lithium, carbamazepine, combined lithium and carbamazepine
DENICOFF1997	USA	41	52%	64%	None allowed	50	29	Lithium	0.5-1.2 mmol/L	7	52
						46	22	Carbamazepine	4-12 mg/L	7	52
						31	22	Lithium and carbamazepine	0.5-1.2 mmol/L/ 4-12 mg/L	7	52
Lithium, valproate, combined lithium and valproate
GEDDES2010	GBR, FRA, USA, ITA	43	49%	100%	Non-investigational co-therapies allowed	110	87	Lithium	0.4–1.0 mmol/L	7	104
						110	89	Valproate	1000 mg	7	104
						110	87	Lithium and valpraote	0.4–1.0 mmol/L/1000 mg	7	104
Lithium, valproate and placebo
BOWDEN2000	NR	39	76%	100%	Lorazepam allowed. Haloperidol permitted during the second consecutive week of lorazepam use (first month only)	187	187	Lithium	0.8-1.2 mmol/L	7	52
						91	89	Valproate	71-125 ug/mL	7	52
						94	93	Placebo	N/A	7	52
Lithium compared with valproate
CALABRESE2005c	USA	37	52%	40%	Lorazepam or alprazolam	32	NR	Lithium	1,400 mg	7	80
CALABRESE2005c	USA	37	52%	40%	Lorazepam or alprazolam	28	NR	Valproate	1,600 mg	7	80
Lithium compared with lamotrigine
LICHT2010	DEN, SWE	38	49%	100%	Antipsychotics and antidepressants allowed (≤ 6 months), benzodiazepines only (> 6 months)	78	NR	Lithium	0.69 mmol/L	7	104
LICHT2010	DEN, SWE	38	49%	100%		77	NR	Lamotrigine	379 mg	7	104
Lamotrigine, lithium and placebo
BOWDEN2003	USA, AUS, AUT, BEL, CAN, GRE, NZL, NOR, POL, UKR	41	53%	100%	Chloral hydrate, lorazepam, temazepam or oxazepam	59	58	Lamotrigine	200 mg	7	76
						46	44	Lithium	0.8-1.1 mEq/L	7	76
						70	69	Placebo	N/A	7	76
CALABRESE2003	Multiple (not specified)	42	39%	100%	Chloral hydrate, lorazepam, temazepam, oxazepam or midazolam	121	NR	Lamotrigine	200 mg	7	72
						121	NR	Lithium	900 mg	7	72
						121	NR	Placebo	N/A	7	72
Lithium, imipramine and placebo
PRIEN1973B	USA	43	23%	NR	None	18	18	Lithium	1,250 mg	7	104
						13	13	Imipramine	125 mg	7	104
						13	13	Placebo	N/A	7	104
Lithium, imipramine and lithium and imipramine combined
PRIEN1984	NR	38	58%	NR	None	42	NR	Lithium	0.6-0.9 mEq/L	7	104
						36	NR	Imipramine	150 mg	7	104
						36	NR	Lithium and Imipramine	0.6-0.9 mEq/L/150 mg	7	104
Olanzapine compared with lithium
TOHEN2005	Multiple (not specified)	42	53%	100%	Haloperidol, zuclopenthixol, benzidiazepine and anticholinergics	217	101	Olanzapine	11.9 mg	7	52
TOHEN2005	Multiple (not specified)	42	53%	100%		214	70	Lithium	1,102.7 mg	7	52
Quetiapine, lithium and placebo
WEISLER2011	Multiple (not specified)	40	53%	100%	None	404	404	Quetiapine	546 mg	7	104
						364	364	Lithium	900 mg	7	104
						404	404	Placebo	N/A	7	104
Antipsychotics
Aripiprazole compared with placebo
CARLSON2012	USA	39	65%	100%	Lorazepam, oxazepam, diazepam, chlorazepate and anticholinergics allowed	178	NR	Aripiprazole	17.4 mg	7	52
CARLSON2012	USA	39	65%	100%		173	NR	Placebo	N/A	7	52
Aripiprazole compared with placebo (all on lithium or valproate)
MARCUS2011	USA, BRA, BUL, CRO, CZE, FRA, IND, RUS, RSA	39	55%	100%	All on lithium or valproate. Benzodiazepines, propranolol and anticholinergics allowed	168	162	Aripiprazole	15 mg	7	52
MARCUS2011	USA, BRA, BUL, CRO, CZE, FRA, IND, RUS, RSA	39	55%	100%		169	164	Placebo	N/A	7	52
TOHEN2004	USA, CAN	41	52%	100%	All on lithium or valproate. Lorazepam and benzatropine mesylate allowed	51	51	Olanzapine	8.6 mg	14	78
TOHEN2004	USA, CAN	41	52%	100%		48	48	Placebo	N/A	14	78
Paliperidone, olanzapine and placebo
BERWAERTS2012	Multiple (not specified)	40	55%	100%	Lorazepam, clonazepam, or diazepam, nonbenzodiazepine hypnotics and anticholinergics	152	146	Paliperidone XR	6 mg	7	129
						83	82	Olanzapine	10 mg	7	129
						148	144	Placebo	N/A	7	129
Quetiapine compared with placebo
YOUNG2012	Multiple (not specified)	40	60%	60%	Zolpidem tartrate or chloral hydrate and anticholinergics allowed	141	NR	Quetiapine	300 mg	7	52
						149	NR	Quetiapine	600 mg	7	52
						296	NR	Placebo	N/A	7	52
Quetiapine compared with placebo (all on lithium or valproate)
SUPPES2009	USA, CAN	40	53%		All on lithium or valproate. Nonpsychoactive medications, lorazepam, zolpidem tartrate, zopiclone, chloral hydrate and anticholinergics allowed	310	173	Quetiapine	519 mg	7	104
SUPPES2009	USA, CAN	40	53%			313	229	Placebo	N/A	7	104
VIETA2008b	USA, AUS, BEL, BUL, CZE, FRA, GER, HUN, ITA, NOR, POL, RUS, RSA, ESP, SVK, TUR, GBR	42	55%	100%	All on lithium or valproate. Zolpidem, zaleplon, zopiclone, chloral hydrate, lorazepam and anticholinergics allowed	336	336	Quetiapine	497 mg	7	104
VIETA2008b		42	55%	100%		367	367	Placebo	N/A	7	104
Quetiapine compared with valproate
LANGOSCH2008	GER	42	60%	50%	No psychoactive medication allowed	24	21	Quetiapine	500 mg	7	52
LANGOSCH2008	GER	42	60%	50%	No psychoactive medication allowed	20	16	Valproate	1,300 mg	7	52
Risperidone long-acting injectable compared with placebo
QUIROZ2010	AUT, IND, MAS, POL, RUS, SVK, ESP, TWN, UKR, USA	39	49%	100%	Nonbenzodiazepine hypnotics, benzodiazepines, propranolol, and anticholinergic medications allowed	154	135	Risperidone (injection)	25 mg	0.5	104
QUIROZ2010	AUT, IND, MAS, POL, RUS, SVK, ESP, TWN, UKR, USA	39	49%	100%		149	133	Placebo (injection)	N/A	0.5	104
Risperidone long-acting injectable, olanzapine and placebo
VIETA2012	Multiple (unspecified)	36	52%	100%	Non-benzodiazepine hypnotics, lorazepam, clonazepam, diazepam and anticholinergic medications allowed	137	135	Risperidone (injection)	25 mg	0.5	78
						138	137	Olanzapine	10 mg	7	78
						140	138	Placebo (injection)	N/A	0.5	78
Risperidone long-acting injectable compared with treatment as usual
MACFADDEN2009	USA, IND	39	28%	100%	Antidepressants, mood stabilisers or anxiolytics	65	65	Risperidone (injection) + TAU	12.5 mg	0.5	52
MACFADDEN2009	USA, IND	39	28%	100%	Antidepressants, mood stabilisers or anxiolytics	59	59	Placebo (injection) + TAU	N/A	0.5	52
BOBO2011b	USA	40	67%	73%	Oral antipsychotics, mood stabilisers, antidepressants, benzodiazepines and anticholinergics	25	20	Risperidone (injection) + TAU	27 mg	0.5	52
BOBO2011b	USA	40	67%	73%		25	25	TAU	N/A	0.5	52
Anticonvulsants
Gabapentin compared with placebo
VIETA2006	ESP	49	72%	76%	Lithium, valproate, carbamazepine or combination	12	12	Gabapentin	300 mg	7	52
VIETA2006	ESP	49	72%	76%	Lithium, valproate, carbamazepine or combination	13	13	Placebo	N/A	7	52
Oxcarbazepine compared with placebo
VIETA2008	ESP	44	65%	76%	All on lithium, lorazepam allowed	26	26	Oxcarbazepine	1,200 mg	7	52
VIETA2008	ESP	44	65%	76%	All on lithium, lorazepam allowed	29	29	Placebo	N/A	7	52
Antidepressants
Imipramine compared with placebo (all on lithium)
QUITKIN1981	USA	37	52%	100%	Lithium only	37	37	Imipramine	125 mg	7	82
QUITKIN1981	USA	37	52%	100%	Lithium only	38	38	Placebo	N/A	7	82
Antidepressants compared with placebo
GHAEMI2010	USA	37	50%	50%	Lithium, lamotrigine and/or divalproex	32	32	Antidepressants¹	Variable	7	52
GHAEMI2010	USA	37	50%	50%	Lithium, lamotrigine and/or divalproex	38	38	Placebo	N/A	7	52

: Note
1: The most frequently employed antidepressant class was serotonin reuptake inhibitors (52%). Common specific agents were bupropion and paroxetine (22% each) and citalopram and venlafaxine (19% each). No tricyclic antidepressants were used.

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Bookshelf ID: NBK545960

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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 19, Interventions for Long-Term Management – Study Characteristics.
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