| Methods |
Design: three group, three period cross‐over trial
Purpose: to examine the effect of discontinuation of antiparkinsonian medication in patients maintained on neuroleptics |
| Participants |
Patients: psychiatric in‐patients on concomitant antiparkinsonian and neuroleptic medication for over one year
Baseline comparability: not relevant |
| Interventions |
Placebo: capsules with no antiparkinsonian medication
Untreated: no capsules
Experimental: capsules with antiparkinsonian medication (type and dose individual but fixed through trial)
(Co‐intervention: yes, neuroleptics, fixed dose through trial except for three patients) |
| Outcomes |
Number of patients with relapse of parkinsonian symptoms (= need for escape medication)
Extrapyramidal Symptom Rating Scale (ESRS) |
| Notes |
The outcome data was not available from the first period only, and was calculated as deriving from a parallel group trial. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'The medication periods were assigned blindly...' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Unclear risk |
The outcome data from this cross‐over trial was not available from the first period only, and was calculated as deriving from a parallel group trial. |
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
High risk |
N = 44 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
