PMID- 22372512
OWN - NLM
STAT- MEDLINE
DCOM- 20120815
LR  - 20131121
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Linking)
VI  - 22
IP  - 2
DP  - 2012 Apr
TI  - A phase 2a randomized, parallel group, dose-ranging study of molindone in 
      children with attention-deficit/hyperactivity disorder and persistent, serious 
      conduct problems.
PG  - 102-11
LID - 10.1089/cap.2011.0087 [doi]
AB  - OBJECTIVE: To evaluate safety and tolerability of four doses of immediate-release 
      molindone hydrochloride in children with attention-deficit/hyperactivity disorder 
      (ADHD) and serious conduct problems. METHODS: This open-label, parallel-group, 
      dose-ranging, multicenter trial randomized children, aged 6-12 years, with ADHD 
      and persistent, serious conduct problems to receive oral molindone thrice daily 
      for 9-12 weeks in four treatment groups: Group 1-10 mg (5 mg if weight <30 kg), 
      group 2-20 mg (10 mg if <30 kg), group 3-30 mg (15 mg if <30 kg), and group 4-40 
      mg (20 mg if <30 kg). The primary outcome measure was to evaluate safety and 
      tolerability of molindone in children with ADHD and serious conduct problems. 
      Secondary outcome measures included change in Nisonger Child Behavior Rating 
      Form-Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem subscale scores, 
      change in Clinical Global Impressions-Severity (CGI-S) and -Improvement (CGI-I) 
      subscale scores from baseline to end point, and Swanson, Nolan, and Pelham rating 
      scale-revised (SNAP-IV) ADHD-related subscale scores. RESULTS: The study 
      randomized 78 children; 55 completed the study. Treatment with molindone was 
      generally well tolerated, with no clinically meaningful changes in laboratory or 
      physical examination findings. The most common treatment-related adverse events 
      (AEs) included somnolence (n=9), weight increase (n=8), akathisia (n=4), sedation 
      (n=4), and abdominal pain (n=4). Mean weight increased by 0.54 kg, and mean body 
      mass index by 0.24 kg/m(2). The incidence of AEs and treatment-related AEs 
      increased with increasing dose. NCBRF-TIQ subscale scores improved in all four 
      treatment groups, with 34%, 34%, 32%, and 55% decreases from baseline in groups 
      1, 2, 3, and 4, respectively. CGI-S and SNAP-IV scores improved over time in all 
      treatment groups, and CGI-I scores improved to the greatest degree in group 4. 
      CONCLUSIONS: Molindone at doses of 5-20 mg/day (children weighing <30 kg) and 
      20-40 mg (>/= 30 kg) was well tolerated, and preliminary efficacy results suggest 
      that molindone produces dose-related behavioral improvements over 9-12 weeks. 
      Additional double-blind, placebo-controlled trials are needed to further 
      investigate molindone in this pediatric population.
FAU - Stocks, Jennifer Dugan
AU  - Stocks JD
AD  - Supernus Pharmaceuticals, Inc., Rockville, Maryland 20850, USA. 
      jstocks@supernus.com
FAU - Taneja, Baldeo K
AU  - Taneja BK
FAU - Baroldi, Paolo
AU  - Baroldi P
FAU - Findling, Robert L
AU  - Findling RL
LA  - eng
SI  - ClinicalTrials.gov/NCT00626236
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120228
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Antipsychotic Agents)
RN  - RT3Y3QMF8N (Molindone)
SB  - IM
MH  - Antipsychotic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Attention Deficit Disorder with Hyperactivity/complications/*drug 
      therapy/physiopathology
MH  - Child
MH  - Conduct Disorder/complications/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Humans
MH  - Male
MH  - Molindone/administration & dosage/adverse effects/*therapeutic use
MH  - Psychiatric Status Rating Scales
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2012/03/01 06:00
MHDA- 2012/08/16 06:00
CRDT- 2012/03/01 06:00
PHST- 2012/03/01 06:00 [entrez]
PHST- 2012/03/01 06:00 [pubmed]
PHST- 2012/08/16 06:00 [medline]
AID - 10.1089/cap.2011.0087 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2012 Apr;22(2):102-11. doi: 
      10.1089/cap.2011.0087. Epub 2012 Feb 28.