Bridges-Parlet 1997

Number of groups: Two group

·       Intervention deprescribing group: 22 randomized, 20 completed

·       Control group: 14 randomized, 14 completed

Age: 81.7 ± 6.0 years

Sex: 29 females, 7 males

Participants with dementia: Yes

·       Alzheimer’s disease diagnosed for 23 patients

·       Dementia non-specific diagnosed for 13 patients

·       MMSE = 0 for n=30 (19 or 86% in deprescribing group, and 11 or 79% in continued group)

o   All but one patient scored less than four on the MMSE

Other medicines: Antidepressants:

·       Deprescribing group n=2

·       Continued group n=3

Inclusion criteria:

·       Receiving an antipsychotic (any traditional antipsychotic was acceptable) and who had been on a stable dose for 3 months before study

·       Patients with a diagnosis of dementia; Diagnoses of possible or probable Alzheimer’s Disease were accepted

·       Those with a history of physically aggressive behavioraccording to the referring nursing supervisor

·       Residing in a nursing home

·       Antidepressants were allowed to participate if the medication doses had been stable

Exclusion criteria:

·       Primary psychiatric diagnoses

·       Mental retardation

·       Terminal illness

·       Other recent acute changes in health status (e.g., recent broken hip)

Country: United States

Setting: Residential aged care facilities – five facilities which generally from specialized units within the facility for the special care of people living with dementia

Chlorpromazine-equivalent dose of an antipsychotic: 41.4mg ± 21.7mg (mean, SD)

·       Haloperidol n=21

·       Thioridazine n=9

·       Thiothixene n=3

·       Trifluoperazine n=1

·       Mesoridazine n=1

·       Loxapine n=1

Withdrawal schedule:

·       Abrupt discontinuation if dose was > 50mg chlorpromazine daily

·       Where the original dose was equivalent to 50mg chlorpromazine daily or above, the titration schedule was to halve the dose in week one and to stop in week two.

Comparator: Placebo compared to continued medicine

Adverse drug withdrawal events

Follow-up duration: Four weeks

“subjects were randomly assigned to either withdrawal or no withdrawal. Assignmentwas based on a pre-determined sequence such that three patients were assigned to withdrawal for every two not withdrawn.”

“Five nursing homes referred patients to the study. In almost all instances, referrals originated from units designated for special care for dementia patients within the facilities. Nursing supervisors identified physically aggressive patients with dementia who were currently being treatedwith a neuroleptic.”

“We relied on the judgments of the nursing supervisors regarding the prior presence of physically aggressive behavior.”

“We do not know what criteria the nursing supervisors…”

The methods used for concealing crushed tablets and one case of saline injectionswere described. They appeared adequate.

Adequate steps were taken to ensure nurses remained blinded.

The other observations (the MMSE and whether the patient could walk or not) were carried out by “experienced study personnel who were blindedto treatment assignments.” This does not say how they were kept blinded.

Low attrition rate: “Of the 22 patients who were withdrawn, 20 (91%) completed the 4-week double-blinded withdrawal. Of the 14 patients not withdrawn, all completed the 4-week trial.”

Completion criteria were reported.
Change in physically aggressive behavior was reported.