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. 2022 Nov 14;2022(11):CD012956. doi: 10.1002/14651858.CD012956.pub2

Goldberg 1986.

Study characteristics
Methods 12‐week trial with 2 arms:
  1. thiothixene

  2. placebo


Duration of trial: 12 weeks (after 1 week placebo washout)
Country: USA
Setting: outpatient
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
  1. Current alcoholism or drug addiction

  2. Schizophrenia

  3. Mania

  4. Melancholia

  5. Severe hepatic, renal, or cardiovascular disease

  6. Organic brain syndrome

  7. Mental retardation

  8. History of epilepsy or seizures

  9. Glaucoma

  10. Severe hypertensive or hypotensive cardiovascular disease

  11. Severe metabolic disorders

Interventions Experimental groupTreatment name: thiothixene
Number randomised to group: 24
Duration: 12 weeks
Control/comparison groupComparison name: placebo
Number randomised to group: 26
Duration: 12 weeks
Both groupsConcomitant 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
Outcomes Primary outcomes
  1. BPD severity, measured by SIB‐borderline score assessed at baseline and 12 weeks (EOT)

  2. Mental health status (functioning), measured by GAS. Assessed at baseline and 12 weeks (EOT)


Secondary outcomes
  1. Anger, measured by HSCL‐HOS. Assessed at baseline and 12 weeks (EOT)

  2. Interpersonal problems, measured by HSCL‐INT. Assessed at baseline and 12 weeks (EOT)

  3. Psychotic symptoms, measured by SIB‐psychotic. Assessed at baseline and 12 weeks (EOT)

  4. Depression, measured by HSCL‐DEP. Assessed at baseline and 12 weeks (EOT)

  5. Attrition

  6. Adverse effects. Measured by spontaneous reporting

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)
  1. "If one were to ask whether our results indicate that patients with BPD and/or SPD can be treated effectively with thiothixene, our answer would have to be "not as these diagnoses are currently defined in DSM‐III," because we found no drug effect on the total borderline score, schizotypal score, or on the Global Assessment Scale"."However, we would go on to say that there are some patients with these diagnoses who do respond to thiothixene and they are the ones who were more severely ill at baseline with regard to illusions, ideas of reference, psychoticism, phobic anxiety, and obsessive‐compulsivity." (Goldberg 1986, p. 685)

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