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. 2021 Jan 10;2021(1):CD013669. doi: 10.1002/14651858.CD013669.pub2

Battaglia 1999.

Study characteristics
Methods Double‐blind RCT. Participants were individually assigned to either 'low' dose (i.e., 12.5 mg/monthly) or 'ultra‐low' dose (i.e., 1.5 mg/monthly) of intramuscular fluphenazine decanoate injections.
Follow‐up period: 6 months.
N lost to follow‐up: 5/58 (8.6%) for repetition of SH.
Participants Number of total participants: 58 participants were randomised, 30 were allocated to the intervention arm (i.e., 12.5 mg/monthly of intramuscular fluphenazine decanoate) and 28 to the control arm (i.e., 1.5 mg/monthly of intramuscular fluphenazine decanoate).
Profile of participants: all (n = 58; 100%) had multiple episodes of SH prior to trial entry. Almost one‐half (n = 28; 44%) were female. The majority were diagnosed with substance misuse disorders (n = 45; 79%), followed by any mood disorder (n = 20; 35%), and any anxiety disorder (n = 17; 29%).
Source of participants: patients presenting to a psychiatric hospital screened for a history of suicide attempts.
Inclusion criteria: i) aged between 18‐65 years; ii) receiving treatment for a suicide attempt that occurred within 30 days prior to trial entry; iii) ≥ 2 prior suicide attempts; iv) able to read English.
Exclusion criteria: i) allergic/hypersensitive to fluphenazine; ii) diagnosed with tardive dyskinesia; iii) a history of neuroleptic malignant syndrome; iv) diagnosed with narrow angle glaucoma; v) diagnosed with schizophrenia; vi) diagnosed with any terminal illness with less than 1 year life expectancy; vii) pregnant or of childbearing age and not using effective birth control; viii) current/expected to continue with treatment using medications with psychotropic effects.
Interventions Intervention: 12.5 mg/monthly of intramuscular fluphenazine decanoate administered by intramuscular injection.
Control: 1.5 mg/monthly of intramuscular fluphenazine decanoate administered by intramuscular injection.
Concomitant medication(s): benztropine was administered, as necessary, to prevent extra‐pyramidal symptoms. It is unclear what proportion of the intervention and control groups were using concomitant medications, however.
Length of treatment: six months.
Location: Dallas, Texas, USA.
Outcomes Primary outcome(s): repetition of SH according to self‐report.
Secondary outcome(s): i) adverse effects, as measured by the Abnormal Involuntary Movement Scale; ii) alcohol and other drug use, as measured by an idiosyncratic checklist developed by the authors; iii) suicide (unclear how ascertained).
Notes Funding: “This research was supported in part by a grant from The National Institute of Mental Health (MH‐53799) and by Mental Health Connections, a partnership between Dallas County Mental Health Mental Retardation and the Department of Psychiatry at the University of Texas South‐Western Medical Centre. Funding was from the Texas State Legislature and Dallas Country Mental Health and Mental Retardation” (Battaglia 1999, p.370).
Conflict(s) of interest: no details provided.
Other: data on suicides were obtained following correspondence with authors.