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

Soloff 1993.

Study characteristics
Methods 5‐week trial with 3 arms:

  1. haloperidol

  2. phenelzine sulphate

  3. placebo


Duration: 5 weeks (after 1‐week washout)
Country: USA
Setting: patients in the hospital for a minimum of 2 weeks and after discharge were seen weekly as outpatients
Participants Method of recruitment of participants: Patients were recruited from the inpatient services of the Western Psychiatric Institute and Clinic of the University of Pittsburgh (PA).
Overall sample size: 108
Diagnosis of borderline personality disorder: DSM‐III‐R
Means of assessment: DIB
Mean age: 26.7 years (SD 7.2; range = no information)
Sex: 75.93% women, 24.07% men
Comorbidity: Patients with a current diagnosis of major depressive disorder without psychosis were included and coded for separate statistical analysis.
Inclusion criteria: no information
Exclusion criteria

  1. Drug and/or alcohol‐related deficits or physical dependence

  2. Evidence of central nervous system disease

  3. Physical disorders of known psychiatric consequence

  4. Borderline mental retardation
Interventions Experimental group 1
Treatment name: haloperidol
Number randomised to group: 30
Duration: 5‐week acute treatment trial followed by 16 weeks continuation treatment for medication responders
Experimental group 2
Treatment name: phenelzine sulphate
Number randomised to group: 34
Duration: 5‐week acute treatment trial followed by 16 weeks continuation treatment for medication responders
Control/comparison group
Comparison name: placebo
Number randomised to group: 28
Duration: 5‐week acute treatment trial followed by 16 weeks continuation treatment for medication responders
All groups
Concomitant psychotherapy: not specified. Patients were inpatients; some were allowed to complete as outpatients after 2 weeks.
Concomitant pharmacotherapy: At the start, patients were kept free of medication for at least 7 days, in order to washout street drugs or prescribed medications.
Proportions of participants taking standing medication during trial observation period: no information
Outcomes Primary outcomes

  1. BPD severity, measured by Borderline Syndrome Index at baseline and once weekly for 5 weeks (EOT)

  2. Mental health status (functioning), measured by GAS at baseline and once weekly for 5 weeks (EOT)


Secondary outcomes

  1. Anger, measured by SCL‐90‐HOS, BDHI, and ADDS‐reactivity at baseline and once weekly for 5 weeks (EOT)

  2. Impulsivity, measured by Ward Scale of Impulsive Action Patterns at baseline and once weekly for 5 weeks (EOT)

  3. Interpersonal problems, measured by ADDS‐rejection sensitivity at baseline and once weekly for 5 weeks (EOT)

  4. Psychotic symptoms, measured by SCL‐90‐PAR, SCL‐90‐PSY, IMPS and SSI at baseline and once weekly for 5 weeks (EOT)

  5. Depression, measured by SCL‐90‐DEP, Ham‐D and BDI at baseline and once weekly for 5 weeks (EOT)

  6. Attrition, measured at week 5 (EOT)

  7. Adverse effects: weight gain, measured at week 5 (EOT)
Notes Sample calculation: no information
Ethics approval: no information
Funding source: funded by grants from universities, authorities or research foundations
Conflicts of interest: No conflicts of interest were reported.
Comments from trial authors (limitations)

  1. Failure to replicate phenelzine efficacy [preceding study: Soloff 1989] may be attributable to our conservative daily dose of phenelzine sulfate (average, 60.45 ± 9.55 mg) or the modest length of our treatment trial (5 weeks) (Soloff 1993, p. 384).

  2. Differences in sample characteristics between studies also may have contributed to our failure to replicate previous reports of efficacy for phenelzine against symptoms of ADD or in patients with ADD and comorbid BPD (Soloff 1993, p. 384).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: insufficient information on methods used to generate random sequence to permit a judgement of low or high risk of bias
Allocation concealment (selection bias) Unclear risk Comment: Insufficient information to permit judgement of low or high risk of bias
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote; "Average daily doses of medication, including placebo pseudo‐dose, are given". (Soloff 1993 p. 380)
Comment: The measures undertaken to ensure blinding seem elaborate and were described in detail, so the blinding of participants seems to have been thoroughly ensured.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Medication could be increased up to six tablets (haloperidol, 6 mg; phenelzine sulfate, 90 mg; placebo, six tablets)" (Soloff 1993 p. 378). Average daily doses of medication, including placebo pseudo‐dose, were given (Soloff 1993 p. 380).
Comment: The measures undertaken to ensure blinding seem elaborate and were described in detail, so the blinding of the rating trial personnel seems to have been thoroughly ensured.
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "Sixteen patients failed to complete the minimum 3 weeks of medication required for end‐point analysis". (Soloff 1993 p. 380)
Comment: Reasons for these dropouts not further specified. Total number of dropouts small, though, and balanced across groups. Continuous outcomes based on all cases with a minimum of 3 weeks of medication exposure. Of the 108 patients enrolled, 92 completed treatment (30 in haloperidol group, 34 in phenelzine group, 28 in placebo group).
Reasons for early termination:
Relating to medication assignment (e.g. side effects), clinical worsening, factors unrelated to the protocol; not specified by group
Patients failing to complete the minimum 3 weeks of medication required for endpoint analysis: 6 in the haloperidol group, 4 in the phenelzine group, 6 in the placebo group
Selective reporting (reporting bias) Unclear risk Comment: no protocol found
Vested Interest (funding and/or author affiliations) Low risk Quote: "This study was supported by National Institute of Mental Health grant MH35392 and by Clinical Research Center grant MH30915." (p. 697)
Quote: ”This work was supported by grants MH35392, MH00658, and CRC30915 from the National Institute of Mental Health,Bethesda, Md.” (Soloff 1993, p.385)
Other bias Low risk Comment: no apparent other sources of bias found