PMID- 32418546
OWN - NLM
STAT- MEDLINE
DCOM- 20210727
LR  - 20210727
IS  - 1601-5215 (Electronic)
IS  - 0924-2708 (Linking)
VI  - 32
IP  - 6
DP  - 2020 Dec
TI  - Effect of the monoaminergic stabiliser (-)-OSU6162 on mental fatigue following 
      stroke or traumatic brain injury.
PG  - 303-312
LID - 10.1017/neu.2020.22 [doi]
AB  - OBJECTIVE: The purpose of the present study was to evaluate the efficacy and 
      safety of (-)-OSU6162 in doses up to 30 mg b.i.d. in patients suffering from 
      mental fatigue following stroke or traumatic brain injury (TBI). METHODS: This 4 
      + 4 weeks double-blind randomised cross-over study included 30 patients afflicted 
      with mental fatigue following a stroke or head trauma occurring at least 12 
      months earlier. Efficacy was assessed using the Mental Fatigue Scale (MFS), the 
      Self-rating Scale for Affective Syndromes [Comprehensive Psychopathological 
      Rating Scale (CPRS)], the Frenchay Activity Index (FAI), and a battery of 
      neuropsychological tests. Safety was evaluated by recording spontaneously 
      reported adverse events (AEs). RESULTS: There were significant differences on the 
      patients' total FAI scores (p = 0.0097), the subscale FAI outdoor scores (p = 
      0.0243), and on the trail making test (TMT-B) (p = 0.0325) in favour of 
      (-)-OSU6162 treatment. Principal component analysis showed a clear overall 
      positive treatment effect in 10 of 28 patients; those who responded best to 
      treatment had their greatest improvements on the MFS. Reported AEs were mild or 
      moderate in severity and did not differ between the (-)-OSU6162 and the placebo 
      period. CONCLUSION: The most obvious beneficial effects of (-)-OSU6162 were on 
      the patients' activity level, illustrated by the improvement on the FAI scale. 
      Moreover, a subgroup of patients showed substantial improvements on the MFS. 
      Based on these observed therapeutic effects, in conjunction with the good 
      tolerability of (-)-OSU6162, this compound may offer promise for treating at 
      least part of the symptomatology in patients suffering from stroke- or 
      TBI-induced mental fatigue.
FAU - Nilsson, Marie K L
AU  - Nilsson MKL
AUID- ORCID: 0000-0001-8750-1059
AD  - Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of 
      Gothenburg, Gothenburg, Sweden.
FAU - Johansson, Birgitta
AU  - Johansson B
AD  - Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of 
      Gothenburg, Gothenburg, Sweden.
FAU - Carlsson, Maria L
AU  - Carlsson ML
AD  - Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of 
      Gothenburg, Gothenburg, Sweden.
FAU - Schuit, Robert C
AU  - Schuit RC
AD  - Department of Radiology and Nuclear Medicine, Amsterdam UMC, location VUmc, 
      Amsterdam, The Netherlands.
FAU - Ronnback, Lars
AU  - Ronnback L
AD  - Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of 
      Gothenburg, Gothenburg, Sweden.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200518
PL  - England
TA  - Acta Neuropsychiatr
JT  - Acta neuropsychiatrica
JID - 9612501
RN  - 0 (Dopamine Agonists)
RN  - 0 (Dopamine Antagonists)
RN  - 0 (Piperidines)
RN  - 0 (Placebos)
RN  - 0 (Receptors, Dopamine)
RN  - 0D21EQAQQA (OSU 6162)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Brain Injuries, Traumatic/*complications
MH  - Case-Control Studies
MH  - Cross-Over Studies
MH  - Dopamine Agonists/adverse effects/blood/therapeutic use
MH  - Dopamine Antagonists/adverse effects/blood/therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Mental Fatigue/*drug therapy/*etiology
MH  - Middle Aged
MH  - Neuropsychological Tests/standards
MH  - Piperidines/adverse effects/blood/*therapeutic use
MH  - Placebos/administration & dosage
MH  - Receptors, Dopamine/*drug effects
MH  - Safety
MH  - Stroke/*complications
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
OTO - NOTNLM
OT  - brain injuries
OT  - drug therapy
OT  - life quality
OT  - mental fatigue
OT  - stroke
EDAT- 2020/05/19 06:00
MHDA- 2021/07/28 06:00
CRDT- 2020/05/19 06:00
PHST- 2020/05/19 06:00 [pubmed]
PHST- 2021/07/28 06:00 [medline]
PHST- 2020/05/19 06:00 [entrez]
AID - S0924270820000228 [pii]
AID - 10.1017/neu.2020.22 [doi]
PST - ppublish
SO  - Acta Neuropsychiatr. 2020 Dec;32(6):303-312. doi: 10.1017/neu.2020.22. Epub 2020 
      May 18.