Efficacy and safety of antidepressants for children and adolescents
BMJ 2004; 328 doi: https://doi.org/10.1136/bmj.328.7444.879 (Published 08 April 2004) Cite this as: BMJ 2004;328:879
Data supplement
Randomised controlled trials of newer antidepressants in young people
Study Participants and drugs Mean (range) age (years) Participants completing Primary outcome measures, with P values for drug v placebo (significant values in bold) Other outcome measures with P values for drug v placebo (significant values in bold) Simeon, 19905 20 fluoxetine 20 placebo
Not stated (13-18) Not stated None nominated No numerical data reported
NS HAM-D CGI
Raskin depression scale
Covi anxiety scale
SCL
NS NS
NS
NS
NS
Mandoki et al, 19976 20 venlafaxine 20 placebo
Not stated (8-17) 16 venlafaxine 17 placebo
None nominated No mean data reported
NS HAM-D CDRS
CBCL
CDI
NS NS
NS
NS
Emslie et al, 19977 48 fluoxetine 48 placebo
12.2 (7-17) 34 fluoxetine 26 placebo
CGI-I response (1 or 2)*: Drug 56%
Placebo 33%
CDRS-R score (mean± SD)*:
Drug 38.4± 14.8
Placebo 47.1± 17.0
*Not the primary outcome measures nominated in the original study protocol
0.02
<0.008
Remission: CDRS £ 28 BDI/CDI
WSAS
CGAS
BPRS-C
NS NS
NS
NS
NS
Keller et al, 20013 95 paroxetine 95 imipramine
87 placebo
14.8 (12-18) 67 paroxetine 58 imipramine
66 placebo
Response (HAM-D£ 8 or ¯³ 50%)* Drug 66.5%
Placebo 55.2%
Change in HAM-D score from baseline:
Drug 18.98 (SE 0.43) to 8.24 (SE 0.81) Placebo 19.97 (SE 0.44) to 9.88 (SE 0.83)
0.11
0.13
¯ depression item, HAM-D ¯ depression item, K-SADS
CGI 1 or 2
¯ 9 item K-SADS
Mean CGI-I
Self-perception profile
Autonomous Fn CL (parent)
Sickness impact scale
0.001 0.05
0.02
0.07
0.09
NS
NS
NS
Emslie et al, 20028 109 fluoxetine 110 placebo
12.7 (8-18) 90 fluoxetine 68 placebo
Response (³ 30% ¯ CDRS-R): Drug 65.1%
Placebo 53.5%
0.09 Remission: CDRS-R£ 28 Change CDRS-R
CDRS subscales
CGI-S
CGI-I
HAM-A
GAF
BDI/CDI
<0.01 <0.001
<0.05
<0.001
<0.02
NS
NS
NS
Wagner et al, 20039 185 sertraline 179 placebo
Not stated (6-17) 139 sertraline 148 placebo
Mean reduction in CDRS-R: Drug - 22.84 (no SD reported)
Placebo - 20.19
0.007 Change CGI-S Change CGI-I
CGI responders (<3)
MASC
CGAS
PQ-LES-Q
0.05 0.005
0.05
NS
NS
NS
Braconnier et al, 200210 63 paroxetine 58 clomipramine
16.2 (12-20) 43 paroxetine 34 clomipramine
CGI-I response ³ 50% ¯ MADRS
NS v TCA GAF* CDI*
SCL*
*No placebo group. NS difference between SSRI and TCA on all measures
BDI=Beck depression inventory; BPRS-C=brief psychiatric rating scale-children; CBCL=child behaviour checklist; CDI=children’s depression inventory; CDRS-R=children’s depression rating scale-revised; CGAS=children’s global assessment scale; CGI-S(I)=clinical global impression-severity (improvement); HAM-D/A=Hamilton rating scale (depression/anxiety); K-SADS=schedule for affective disorders and schizophrenia for adolescents; MADRS=Montgomery and Asperg depression rating scale; MASC=multidimensional anxiety scale for children; PQ-LES-Q=pediatric quality of life enjoyment and satisfaction; SCL=Hopkins symptom CL; SSRI=selective serotonin reuptake inhibitor; TCA=tricyclic antidepressant; WSAS=Weinberg screening assessment scale.
Related articles
- This Week In The BMJ Published: 08 April 2004; BMJ 328 doi:10.1136/bmj.328.7444.0
- Paper Published: 08 April 2004; BMJ 328 doi:10.1136/bmj.38058.605787.AE
- Correction Published: 13 May 2004; BMJ 328 doi:10.1136/bmj.328.7449.1170-b
- PAPERS Published: 05 April 2004; BMJ doi:10.1136/bmj.38058.605787.AE
- Feature Published: 11 October 2007; BMJ 335 doi:10.1136/bmj.39316.406470.94
- Education And Debate Published: 21 April 2005; BMJ 330 doi:10.1136/bmj.330.7497.956
- Feature Published: 11 October 2007; BMJ 335 doi:10.1136/bmj.39316.399931.94
- Letter Published: 02 December 2004; BMJ 329 doi:10.1136/bmj.329.7478.1343-d
See more
- An adolescent with disabling abdominal painBMJ December 07, 2016, 355 i6101; DOI: https://doi.org/10.1136/bmj.i6101
- Maternal deaths from suicide must be tackled, say expertsBMJ December 07, 2016, 355 i6585; DOI: https://doi.org/10.1136/bmj.i6585
- Andrew Wakefield calls Trump “on our side” over vaccines after meetingBMJ December 05, 2016, 355 i6545; DOI: https://doi.org/10.1136/bmj.i6545
- Electronic fetal monitoring, cerebral palsy, and caesarean section: assumptions versus evidenceBMJ December 01, 2016, 355 i6405; DOI: https://doi.org/10.1136/bmj.i6405
- Clinical commissioning groups will be rated on sepsis careBMJ November 25, 2016, 355 i6361; DOI: https://doi.org/10.1136/bmj.i6361
Cited by...
- Suicidality and other severe psychiatric events with duloxetine: Re-analysis of safety data from a placebo-controlled trial for juvenile fibromyalgia
- White Paper: Efficacy of Psychiatric Drugs
- The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance
- Assessment and management of bipolar disorder: summary of updated NICE guidance
- Mother's country of birth and prescription of psychotropic medication in Swedish adolescents: a life course approach
- Industry attack on academics
- The ethics of paediatric anti-depressant use: erring on the side of caution
- Efficacy of antidepressants in juvenile depression: meta-analysis
- Child psychiatry and its relationship with the pharmaceutical industry: theoretical and practical issues
- Should young people be given antidepressants? No
- Should young people be given antidepressants? Yes
- Effectiveness of Changing Minds campaign factsheets in reducing stigmatised attitudes towards mental illness
- Suicidal behaviour in youths with depression treated with new-generation antidepressants: Meta-analysis
- Forensic database study suggests selective serotonin reuptake inhibitors do not increase the risk of suicide in people taking antidepressants
- Wishful thinking: antidepressant drugs in childhood depression
- Should we prescribe antidepressants to children?
- Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)
- Managing attention deficit/hyperactivity disorder: unmet needs and future directions
- Rethinking childhood depression
- TADS study raises concerns
- A drug utilisation study of antidepressants in children and adolescents using the General Practice Research Database
- Lucina
- Other articles noted
- Use of stimulants for attention deficit hyperactivity disorder: AGAINST
- Other articles noted
- Other articles noted
- SSRIs: Reconsidering Their Role in Childhood Depression
- SSRI treatment for under-18s
- SSRI treatment for under-18s
- SSRIs: Reconsidering Their Role in Childhood Depression