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: 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.