Interventions for Mania - 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 12Interventions for Mania - Study Characteristics

Abbreviations

AUS: Australia
BEL: Belgium
BGR: Bulgaria
BPI: bipolar I
CHN: China
DEU: Germany
Dur: duration in months
Freq: frequency
HKG: Hong Kong
IND: India
IRN: Iran, Islamic Republic of
ISR: Israel
JPN: Japan
KOR: Korea
N Rand: number of participants randomised
N Post: number of participants at post-treatment
NR: not reported
PHL: Philippines
RUS: Russian Federation
TMS: transcranial magnetic stimulation
TWN: Taiwan
UKR: Ukraine
USA: United States
ZAF: South Africa

1.1. Pharmacological Interventions

Study¹	Country	Age	% Female	% BPI	Concomitant medication	N Rand	N Post	Group	Dose	Freq	Dur
Pharmacological interventions
CIPRIANI2011	NR	NR	NR	NR	NR	1,284	NR	Aripiprazole	30-50 mg	NR	3-6
						379	NR	Asenapine	10-20 mg	NR	3
						315	NR	Carbamazepine	200-1,600 mg	NR	2-6
						59	NR	Gabapentin	600-3,600 mg	NR	3
						1,101	NR	Haloperidol	2-80 mg	NR	2-6
						174	NR	Lamotrigine	50-100 mg	NR	3-6
						912	NR	Lithium	28-1,800 mg	NR	3-6
						1,927	NR	Olanzapine	2-30 mg	NR	3-6
						692	NR	Paliperidone	3-12 mg	NR	3-6
						5,139	NR	Placebo	N/A	NR	3-6
						832	NR	Quetiapine	200-800 mg	NR	3-4
						740	NR	Risperidone	1-6 mg	NR	3-4
						802	NR	Topiramate	50-600 mg	NR	3
						916	NR	Valproate	500-2,500 mg	NR	3-4
						1,033	NR	Ziprasidone	40-160 mg	NR	3

Study	Country	Age	% Female	% BPI	Concomitant medication	N Rand	N Post	Group	Dose	Freq	Dur
Pharmacological interventions
KANBA2012	CHN, HKG, JPN, PHL, TWN	38	59%	100%	Short-acting benzodiazepine and anti-anxiety agents allowed	128	122	Aripiprazole	20 mg	7	3
KANBA2012	CHN, HKG, JPN, PHL, TWN	38	59%	100%	Short-acting benzodiazepine and anti-anxiety agents allowed	130	125	Placebo	N/A	7	3
SZEGEDI2012	AUS, IND, KOR, RUS, THA, USA	39	69%	100%	Lithium or valproate. Benzodiazepines allowed	159	155	Asenapine	12 mg	7	12
SZEGEDI2012	AUS, IND, KOR, RUS, THA, USA	39	69%	100%	Lithium or valproate. Benzodiazepines allowed	167	163	Placebo	N/A	7	12
ASTRAZENECA2011	BEL, BGR, DEU, IND, RUS, UKR, ZAF	38	38%	100%	NR	173	173	Lithium and quetiapine	450 mg/300 mg	14	6
ASTRAZENECA2011	BEL, BGR, DEU, IND, RUS, UKR, ZAF	38	38%	100%	NR	183	176	Placebo and quetiapine	300 mg	14	6

1.2. Nutritional Interventions

Study	Country	Age	% Female	% BPI	Concomitant medication	N Rand	N Post	Group	Dose	Freq	Dur
Nutritional interventions
Omega-3 fatty acids compared with placebo
CHIU2005	CHN	NR	NR	100%	Carbamazepine, lithium or valproate	NR	NR	Eicosapentaenoic acid and docosahexaenoic acid	440 mg/240 mg	14	4
CHIU2005	CHN	NR	NR	100%	Carbamazepine, lithium or valproate	NR	NR	Placebo	N/A	14	4
Folic acid compared with placebo
BEHZADI2009	IRN	35	70%	100%	Valproate	44	41	Folic acid	3 mg	7	3
BEHZADI2009	IRN	35	70%	100%	Valproate	44	43	Placebo	N/A	7	3

1.3. Physical Interventions

Study	Country	Age	% Female	% BPI	Concomitant medication	N Rand	N Post	Group	Dose	Freq	Dur
Physical interventions
Acupuncture compared with sham acupuncture
DENNEHY2009A	USA	37	55%	60%	Medication as usual	10	5	Acupuncture	N/A	2	5
DENNEHY2009A	USA	37	55%	60%	Medication as usual	10	7	Sham	N/A	2	5
Transcranial magnetic stimulation (TMS) compared with sham TMS
KAPTSAN2003	ISR	42	53%	100%	Medication as usual	16	11	TMS	20 minutes	7	2
KAPTSAN2003	ISR	42	53%	100%	Medication as usual	9	8	Sham	20 minutes	7	2

Footnotes

1: Studies are listed alphabetically by drug (group).

All rights reserved. No part of this guideline may be reprinted or reproduced or utilised in any form or by any electronic, mechanical, or other means, now known or hereafter invented, or in any information storage or retrieval system, without permission in writing from the National Collaborating Centre for Mental Health. Enquiries in this regard should be directed to the Centre Administrator: ku.ca.hcyspcr@nimdAHMCCN

Bookshelf ID: NBK545966

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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 12, Interventions for Mania - Study Characteristics.
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