PMID- 24955812
OWN - NLM
STAT- MEDLINE
DCOM- 20151022
LR  - 20211021
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 24
IP  - 6
DP  - 2014 Aug
TI  - A double-blind, placebo-controlled study of selegiline transdermal system in 
      depressed adolescents.
PG  - 311-7
LID - 10.1089/cap.2013.0138 [doi]
AB  - OBJECTIVE: A randomized, double-blind, placebo-controlled flexible-dose, parallel 
      group trial was conducted at 26 clinical investigational sites in the United 
      States to examine the safety and efficacy of the selegiline transdermal system 
      (STS) (EMSAM(R)) in adolescents (ages 12-17 years) meeting American Psychiatric 
      Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. 
      (DSM-IV) criteria for moderate to severe major depressive disorder (MDD) without 
      psychotic features. METHODS: Adolescents (n=308) with moderate to severe MDD were 
      randomized to either STS (n=152) or placebo (n=156). Two hundred and fifteen 
      (69.8%) subjects completed the study and 17 (5.5%) reported discontinuation 
      because of adverse events (AEs). The primary efficacy outcome measure was the 
      mean change from baseline to end of study (week 12 last observation carried 
      forward [LOCF]) in the Children's Depression Rating Scale-Revised (CDRS-R) total 
      score. Secondary outcome measures included end-point Clinical Global Impressions 
      - Severity (CGI-S) and Clinical Global Impressions - Improvement (CGI-I). 
      RESULTS: Patients on STS or placebo had a significant decline from baseline 
      (p<0.001) on their CDRS-R total score with mean reductions+/-SD as follows: STS 
      21.4+/-16.6; placebo 21.5+/-16.5. Both groups had similar response rates (58.6% vs. 
      59.3%) defined as CGI-I of 1 or 2 at study end. However, these between-group 
      efficacy findings were without statistical significance. The overall incidence of 
      reported AEs was 62.5% for STS-treated patients and 57.7% for placebo-treated 
      patients. Most commonly reported AEs in STS or placebo groups were application 
      site reactions (STS=24.3%; placebo=21.8%), headache (STS=17.1%; placebo=16.7%), 
      and nausea (STS=7.2%; placebo=7.7%). Treatment groups did not differ on any 
      laboratory parameters, vital signs, or electrocardiogram (ECG) findings. No 
      suspected hypertensive crises were reported in the trial. CONCLUSIONS: These data 
      demonstrated that the STS was safe and well tolerated in this adolescent sample. 
      However, both STS-treated and placebo-treated subjects demonstrated a decline 
      from baseline in depressive symptoms (CDRS-R total score) over the length of the 
      study, without statistical superiority by either group.
FAU - DelBello, Melissa P
AU  - DelBello MP
AD  - 1 Department of Psychiatry and Behavioral Neuroscience, Division of Bipolar 
      Disorders Research, University of Cincinnati College of Medicine , Cincinnati, 
      Ohio.
FAU - Hochadel, Thomas J
AU  - Hochadel TJ
FAU - Portland, Kimberly Blanchard
AU  - Portland KB
FAU - Azzaro, Albert J
AU  - Azzaro AJ
FAU - Katic, Alain
AU  - Katic A
FAU - Khan, Arif
AU  - Khan A
FAU - Emslie, Graham
AU  - Emslie G
LA  - eng
GR  - UL1 TR001425/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140623
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Antidepressive Agents)
RN  - 2K1V7GP655 (Selegiline)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Antidepressive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Child
MH  - Depressive Disorder, Major/*drug therapy/physiopathology
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Selegiline/administration & dosage/adverse effects/*therapeutic use
MH  - Severity of Illness Index
MH  - Transdermal Patch
MH  - Treatment Outcome
PMC - PMC4137354
EDAT- 2014/06/24 06:00
MHDA- 2015/10/23 06:00
PMCR- 2015/08/01
CRDT- 2014/06/24 06:00
PHST- 2014/06/24 06:00 [entrez]
PHST- 2014/06/24 06:00 [pubmed]
PHST- 2015/10/23 06:00 [medline]
PHST- 2015/08/01 00:00 [pmc-release]
AID - 10.1089/cap.2013.0138 [pii]
AID - 10.1089/cap.2013.0138 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2014 Aug;24(6):311-7. doi: 
      10.1089/cap.2013.0138. Epub 2014 Jun 23.