PMID- 35857716
OWN - NLM
STAT- MEDLINE
DCOM- 20220722
LR  - 20221101
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 83
IP  - 5
DP  - 2022 Jul 20
TI  - Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the 
      Efficacy and Safety of Amphetamine Extended-Release Tablets in Adults With 
      Attention-Deficit/Hyperactivity Disorder.
LID - 22m14438 [pii]
LID - 10.4088/JCP.22m14438 [doi]
AB  - Objective: To evaluate the efficacy and safety of amphetamine extended-release 
      tablets (AMPH ER TAB) in adults with attention-deficit/hyperactivity disorder 
      (ADHD). Methods: In a 5-week forced-dose titration phase, subjects were 
      randomized to either oral double-blind AMPH ER TAB 5-mg starting dose or matching 
      placebo, once daily in the morning. Safety and efficacy assessments were 
      completed weekly. After visit 3, subjects received 20 mg for 14 +/- 3 days before 
      visit 5. At visit 5, efficacy assessments included the administration of serial 
      Permanent Product Measure of Performance (PERMP) tests predose and at 0.5, 1, 2, 
      4, 8, 10, 12, 13, and 14 hours postdose. The primary efficacy endpoint was the 
      mean PERMP Total score (PERMP-T) across postdose time points during the visit 5 
      serial PERMPs. Safety was monitored by adverse events (AEs) assessed at each 
      visit, Columbia Suicide Severity Rating Scale (C-SSRS), vital signs, weight, 
      physical examination, and assessment of sleep, appetite, mood, and psychotic AEs. 
      The study was conducted from February 2019 to October 2019. Results: Of 130 
      randomized subjects, 127 were in the intent-to-treat (ITT) population and 91 
      completed the study. The mean PERMP-T across all postdose time points at visit 5 
      was statistically significantly higher in the AMPH ER TAB group than in the 
      placebo group (302.8 vs 279.6; P = .0043). Numerical differences favoring AMPH ER 
      TAB were seen at all time points, with statistically significant improvements in 
      the AMPH ER TAB group at 30 minutes and 1, 2, 4, 8, and 13 hours postdose, 
      although the 10-, 12-, and 14-hour time points were not significant. Common AEs 
      included decreased appetite, insomnia, and dry mouth. The majority of 
      treatment-emergent AEs were mild to moderate in severity, and no serious AEs, as 
      defined by the US Food and Drug Administration, were reported. Conclusions: AMPH 
      ER TAB demonstrated efficacy in treatment of symptoms of ADHD in adults, with an 
      anticipated safety profile. Trial Registration: ClinicalTrials.gov identifier: 
      NCT03834766.
CI  - (c) Copyright 2022 Physicians Postgraduate Press, Inc.
FAU - Cutler, Andrew J
AU  - Cutler AJ
AD  - Neuroscience Education Institute, Lakewood Ranch, Florida.
AD  - Department of Psychiatry, SUNY Upstate Medical University, Syracuse, New York.
FAU - Childress, Ann C
AU  - Childress AC
AD  - Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada.
FAU - Pardo, Antonio
AU  - Pardo A
AD  - Tris Pharma, Inc., Monmouth Junction, New Jersey.
FAU - Duhoux, Stephanie
AU  - Duhoux S
AD  - Tris Pharma, Inc., Monmouth Junction, New Jersey.
AD  - Corresponding author: Stephanie Duhoux, PhD, Tris Pharma, Inc., Medical Affairs, 
      2033 US 130, Monmouth Junction, NJ 08852 (sduhoux@trispharma.com).
FAU - Gomeni, Roberto
AU  - Gomeni R
AD  - PharmacoMetrica, La Fouillade, France.
FAU - Rafla, Eman
AU  - Rafla E
AD  - Tris Pharma, Inc., Monmouth Junction, New Jersey.
FAU - King, Thomas R
AU  - King TR
AD  - Tris Pharma, Inc., Monmouth Junction, New Jersey.
FAU - Kando, Judith C
AU  - Kando JC
AD  - Tris Pharma, Inc., Monmouth Junction, New Jersey.
LA  - eng
SI  - ClinicalTrials.gov/NCT03834766
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220720
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Tablets)
RN  - CK833KGX7E (Amphetamine)
SB  - IM
MH  - Adult
MH  - Amphetamine/adverse effects
MH  - *Attention Deficit Disorder with Hyperactivity/chemically induced/drug therapy
MH  - *Central Nervous System Stimulants/therapeutic use
MH  - Delayed-Action Preparations/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Humans
MH  - Tablets
MH  - Treatment Outcome
EDAT- 2022/07/21 06:00
MHDA- 2022/07/23 06:00
CRDT- 2022/07/20 13:23
PHST- 2022/07/20 13:23 [entrez]
PHST- 2022/07/21 06:00 [pubmed]
PHST- 2022/07/23 06:00 [medline]
AID - 22m14438 [pii]
AID - 10.4088/JCP.22m14438 [doi]
PST - epublish
SO  - J Clin Psychiatry. 2022 Jul 20;83(5):22m14438. doi: 10.4088/JCP.22m14438.