Table 1

Study overview (SPIRIT template)

Study period
EnrolmentAllocationPostallocationClose out
Timepoint−2 weeks0 weeks2 weeks
(±3 days)
4 weeks
(±3 days)
6 weeks
(±3 days)
12 weeks
(±1 week)
18 weeks
(±1 week)
24 weeks
(±1 week)
+4–8 weeks
Enrolment:
 Eligibility screenXX
 Informed consentX
 AllocationX
Interventions:
Embedded Image
Methylphenidate
(X=uptitrate dose)
(O=drug dispensed)
OO
X
OOOO
Embedded Image
Placebo
(X=uptitrate dose)
(O=drug dispensed)
OO
X
OOOO
Assessments
 Safety bloods (FBC/LFT/U+Es)XXXXX
 Safety questionnaireXXXXXX
 Pregnancy testXX
 ECGXXXXXX
 SpirometryXXX
 MSWTXXX
 Accelerometer (7 days)XXX
Questionnaires
  FASXXXXXXXXX
 FACIT-FXXXXXXXX
 HADSXXXXXX
 SF-36XXXXXX
 EQ5DXXXXXX
 KSQXXXXXX
 CostsXXX
 PSQIXXXX
  Exit questionnaireX
Focus group (post-trial)X
  • In addition, all participants receive telephone calls at weeks 1, 3, 5, 8, 10, 14, 16, 10 and 22 to review safety (emergence of side effects).

  • EQ5D, EuroQoL-5D-5L; FACIT-F, Functional Assessment of Chronic Illness Therapy – Fatigue; FAS, Fatigue Assessment Scale; FBC, full blood count; HADS, Hospital Anxiety and Depression Score; KSQ, King’s Sarcoidosis Questionnaire; LFT, liver function test; MSWT; modified shuttle walk test; PSQI, Pittsburgh Sleep Quality Index; SF-36, Short Form-36; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; U+Es; urea + electrolytes.