Interventions for Children and Young People – 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 27Interventions for Children and Young People – Study Characteristics

Abbreviations

ADHD: attention deficit hyperactivity disorder
BRA: Brazil
ChIPS: Children’s Interview for Psychiatric Syndromes
COL: Colombia
DSM(-IV, -TR): Diagnostic and Statistical Manual of Mental Disorders (– fourth edition, - Text Revision)
Dur: duration
Freq: frequency
IND: India
IRI: Iran
K-SADS(-PL): Kiddie- Schedule for Affective Disorders and Schizophrenia (-Present and Lifetime Version)
MEX: Mexico
N/A: not applicable
N Post: number of participants at post-treatment
NR: not reported
N Rand: number of participants randomised
P-ChIPS: parent version Children’s Interview for Psychiatric Syndromes
PUR: Puerto Rico
RUS: Russian Federation
TWN: Taiwan
USA: United States of America
WASH-U-KSADS: Washington University in St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia
XR: extended release
ZAF: South Africa

1.1. Pharmacological Interventions

Study	Country	Interview	Age	% Female	% ADHD	N Rand	N Post	Group	Dose	Freq	Dur
Medication for acute mania
Aripiprazole compared with pill placebo
FINDLING2009	USA	K-SADS (DSM-IV)	13	46%	52%	98	96	Aripiprazole	10 mg	7	4
						99	99	Aripiprazole	30 mg	7	4
						99	92	Placebo	N/A	7	4
TRAMONTINA2009	BRA	K-SADS (DSM-IV)	12	56%	100%	18		Aripiprazole	13 mg	7	6
TRAMONTINA2009	BRA	K-SADS (DSM-IV)	12	56%	100%	25		Placebo	N/A	7	6
Olanzapine compared with pill placebo
TOHEN2007	USA, PUR	K-SADS (DSM-IV-TR)	15	47%	99%	107	105	Olanzapine	8.9 mg	7	3
TOHEN2007	USA, PUR	K-SADS (DSM-IV-TR)	15	47%	99%	54	54	Placebo	N/A	7	3
Quetiapine compared with pill placebo
DELBELLO2002	USA	K-SADS (DSM-IV)	14	47%	60%	15	15	Quetiapine	432 mg	7	6
DELBELLO2002	USA	K-SADS (DSM-IV)	14	47%	60%	15	15	Placebo	N/A	7	6
PATHAK2013	USA	K-SADS (DSM-IV)	13	44%	45%	95	95	Quetiapine	400 mg	7	3
						98	98	Quetiapine	600 mg	7	3
						91	90	Placebo	N/A	7	3
Risperidone compared with pill placebo
HAAS2009	USA	NR	13	51%	50%	50	50	Risperidone	0.5-2.5 mg	7	3
						61	61	Risperidone	3-6 mg	7	3
						58	58	Placebo	N/A	7	3
Topiramate compared with pill placebo
DELBELLO2005	USA	K-SADS (DSM-IV)	14	48%	59%	29	27	Topiramate	278 mg	7	4
DELBELLO2005	USA	K-SADS (DSM-IV)	14	48%	59%	27	29	Placebo	N/A	7	4
ELILILLY2011	USA	K-SADS (DSM-IV-TR)	14	55%	NR	17	16	Topiramate	400 mg	7	12
ELILILLY2011	USA	K-SADS (DSM-IV-TR)	14	55%	NR	14	14	Placebo	N/A	7	12
Valproate compared with pill placebo
WAGNER2009	USA	K-SADS (DSM-IV)	13	40%	68%	77	74	Valproate	24.3 mg/kg	7	4
WAGNER2009	USA	K-SADS (DSM-IV)	13	40%	68%	74	70	Placebo	N/A	7	4
Ziprasidone compared with pill placebo
PFIZER2011	USA	K-SADS (DSM-IV)	14	NR	NR	150	133	Ziprasidone	NR	7	4
PFIZER2011	USA	K-SADS (DSM-IV)	14	NR	NR	88	85	Placebo	N/A	7	4
Quetiapine compared with valproate
DELBELLO2006	USA	K-SADS (DSM-IV-TR)	15	58%	32%	25	25	Quetiapine	412 mg	7	4
DELBELLO2006	USA	K-SADS (DSM-IV-TR)	15	58%	32%	25	25	Valproate	101 µg/mL	7	4
Risperidone compared with valproate
PAVULURI2012	USA	WASH-UKSADS (DSM-IV)	13	41%	0%	14	10	Risperidone	144 mg	7	6
PAVULURI2012	USA	WASH-UKSADS (DSM-IV)	13	41%	0%	14	11	Valproate	856 mg	7	6
PAVULURI2010	USA	K-SADS (DSM-IV)	11	38%	19%	33	32	Risperidone	0.5-2 mg	7	6
PAVULURI2010	USA	K-SADS (DSM-IV)	11	38%	19%	33	33	Valproate	NR	7	6
Topiramate compared with valproate
HEBRANI2009	IRI	K-SADS (DSM-IV-TR)	16	60%	NR	71	NR	Topiramate	NR	7	8
HEBRANI2009	IRI	K-SADS (DSM-IV-TR)	16	60%	NR	71	NR	Valproate	NR	7	8
Medication for Acute Depression
Quetiapine compared with placebo
ASTRAZENECA2011B	USA, IND, COL, RUS, MEX, ZAF, TWN	K-SADS (DSM-IV)	14	49%	NR	93	92	Quetiapine XR	300 mg	7	8
ASTRAZENECA2011B	USA, IND, COL, RUS, MEX, ZAF, TWN	K-SADS (DSM-IV)	14	49%	NR	100	100	Placebo	N/A	7	8
DELBELLO2009	USA	K-SADS (DSM-IV-TR)	16	69%	13%	17	17	Quetiapine	400 mg	7	8
DELBELLO2009	USA	K-SADS (DSM-IV-TR)	16	69%	13%	15	15	Placebo	N/A	7	8
Fluoxetine and olanzapine compared with placebo
ELILILLY2013	USA, RUS, MEX	K-SADS-PL (DSM-IV-TR)	15	56%	NR	194	170	Fluoxetine and olanzapine	12 mg/50 mg	7	8
ELILILLY2013	USA, RUS, MEX	K-SADS-PL (DSM-IV-TR)	15	56%	NR	97	85	Placebo	N/A	7	8
Long term management
FINDLING2005	USA	K-SADS (DSM-IV)	11	35%	58%	30	30	Lithium	30 mg/kg	7	20
FINDLING2005	USA	K-SADS (DSM-IV)	11	35%	58%	30	30	Valproate (divalproex sodium)	20 mg/kg	7	20
FINDLING2012	USA	K-SADS (DSM-IV)	7	30%	90%	30	30	Aripiprazole	0.26 mg/kg	7	72
FINDLING2012	USA	K-SADS (DSM-IV)	7	30%	90%	30	30	Placebo	N/A	7	72

1.2. Psychological Interventions

Study	Country	Interview	Age	% Female	% ADHD	N Rand	N Post	Group	Dur
CUMMINGS2007	USA	ChIPS and P-ChIPS (DSM-IV)	10	27%	97%	87	87	Family psychoeducation	26
CUMMINGS2007	USA	ChIPS and P-ChIPS (DSM-IV)	10	27%	97%	79	78	Waitlist	26
MIKLOWITZ2008	USA	K-SADS (DSM-IV)	15	57%	89%	30	26	Family therapy	39
MIKLOWITZ2008	USA	K-SADS (DSM-IV)	15	57%	89%	28	24	Enhanced clinical intervention	39

1.3. Nutritional Interventions

Study

Country

Interview

Age

% Female

% ADHD

N Rand

N Post

Group

Dose

Freq

Dur

GRACIOUS2010

USA

K-SADS

(DSM-IV)

13.7

47%

53%

Flax oil

3,300 mg

Placebo

N/A

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Bookshelf ID: NBK545944

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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 27, Interventions for Children and Young People – Study Characteristics.
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