Goldberg 1986.
Study characteristics | ||
Methods | 12‐week trial with 2 arms:
Duration of trial: 12 weeks (after 1 week placebo washout) Country: USA Setting: outpatient |
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Participants |
Methods of recruitment of patients: "A short version of the SIB was placed as an advertisement in the local newspaper to recruit patients". (Goldberg 1986, p. 681) Overall sample size: 40 Diagnosis of borderline personality disorder: DSM‐III Means of assessment: Schedule of Interviewing Schizotypal Personalities (SIB) Mean age: 32 years (SD = no information; range = no information) Sex: 58% women Comorbidity: schizotypal personality disorder and having at least one psychotic symptom Inclusion criteria: no information Exclusion criteria
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Interventions |
Experimental group
Treatment name: thiothixene
Number randomised to group: 24
Duration: 12 weeks Control/comparison group Comparison name: placebo Number randomised to group: 26 Duration: 12 weeks Both groups Concomitant psychotherapy: no information Concomitant pharmacotherapy: participants had to pass one week placebo washout, no further details Proportions of participants taking standing medication during trial observation period: no information |
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Outcomes |
Primary outcomes
Secondary outcomes
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Notes |
Sample calculation: no information Ethics approval: no information Funding source: unclear funding Conflicts of interest: No conflicts of interest were reported. Comments from trial authors (limitations)
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: Insufficient information on the method used for random sequence generation to permit a judgement of low or high risk of bias |
Allocation concealment (selection bias) | Unclear risk | Comment: no information given on allocation concealment to permit a judgement of low or high risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Both agents were provided in identical‐appearing capsules containing 5 mg of thiothixene hydrochloride or an equivalent amount of lactose for placebo. The initial dose for all patients was one capsule [...] and on each succeeding visit the dose was increased by one capsule unless side‐effects or marked improvement intervened. A maximum dose of 40 mg, or eight capsules, was to be allowed [...]." (Goldberg 1986, p. 682) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: The article referred to the trial being double‐blind, however, there was insufficient information on how blinding of outcome assessors was carried out and maintained to permit a judgement of low or high risk of bias. |
Incomplete outcome data (attrition bias) All outcomes | Low risk |
Quote: "Patients who terminated their participation early were assessed at that point and those assessments were taken as their endpoints." (Goldberg 1986, p. 682) Comment: Of the 50 patients enrolled, 40 completed treatment (17 in thiothixene group, 23 in placebo group). Reasons for early termination: Adverse effects: 7 in thiothixene group, 0 in placebo group Lack of efficacy: 0/3 Continuous data based on LOCF |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found |
Vested Interest (funding and/or author affiliations) | Unclear risk | Comment: no details on sponsoring or funding. Authors affiliated with the Department of Psychiatry, Medical College of Virginia/Virginia Commonwealth University, Richmond |
Other bias | Low risk | Comment: No apparent other sources of bias found |