Skip to main content
. 2022 Nov 14;2022(11):CD012956. doi: 10.1002/14651858.CD012956.pub2

De la Fuente 1994.

Study characteristics
Methods 32‐day trial with 2 arms:

  1. carbamazepine (CBZ)

  2. placebo (PLC)


Duration of trial: 32 days (after at least 10 days psychotropic drug washout, 15 days for TCAs and MAOIs; no patient had taken neuroleptics in the 2‐month period before the trial)
Country: Belgium
Setting: inpatient
Participants Methods of recruitment of patients: no information
Overall sample size: 20
Diagnosis of borderline personality disorder: DSM‐III‐R
Means of assessment: DIB
Mean age: 32.7 years (SD = no information; range = 22‐45)
Sex: 70% women
Comorbidity: no information
Inclusion criteria

  1. Fulfilling the DSM‐III‐R criteria for BPD

  2. Score of at least 7 in the Gunderson and Kolb DIB


Exclusion criteria

  1. Standard physical or neurological examinations abnormal

  2. Perturbed standard biological blood tests

  3. Perturbed electrocardiogram

  4. DSM‐III‐R axis I disturbances

  5. Positive history for epilepsy or standard EEG traits of epilepsy

  6. Antecedents of encephalitis or cranial trauma

  7. Inability to stop alcohol or psychoactive substances

  8. Suspected poor treatment compliance

  9. Meeting the criteria for major depression on DSM‐III‐R (however, patients depressed for less than 2 weeks were not excluded)
Interventions Experimental group
Treatment name: carbamazepine
Number randomised to group: 10
Duration: 32 days
Control/comparison group
Comparison name: placebo
Number randomised to group: 10
Duration: 32 days
Both groups
Concomitant psychotherapy: Supportive atheoretical psychotherapy was administered to all patients.
Concomitant pharmacotherapy: There was a 10‐day psychotropic drug washout prior to the trial and a 15‐day drug washout for TCAs and MAOIs. "No patient had taken neuroleptics in the 2‐month period before the study." (De la Fuente 1994, p. 480)
Proportions of participants taking standing medication during trial observation period: no further details
Outcomes Primary outcomes: none
Secondary outcomes

  1. Anger, measured by SCL‐90‐HOS. Assessed at baseline, day 8 and day 32 (EOT)

  2. Impulsivity, measured by Acting‐out scale. Recorded with day‐by‐day events

  3. Interpersonal problems, measured by SCL‐90‐INT. Assessed at baseline, day 8 and day 32 (EOT)

  4. Psychotic symptoms, measured by BPRS, SCL‐90‐PSY and SCL‐90‐PAR. Assessed at baseline, day 8 and day 32 (EOT)

  5. Depression, measured by HDRS‐24. Assessed at baseline, day 8 and day 32 (EOT)

  6. Attrition

  7. Adverse effects, asked for by a non‐blind clinician at baseline, day 8, day 16, and day 32 (EOT)
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. "The number of BPD patients that achieved the CBZ treatment period was small (only eight for the whole study)." (De la Fuente 1994, p. 484)

  2. "In the present work, CBZ was given only for 32 days. Maybe the positive trends observed in the CBZ group could have been significant with a more prolonged administration." (De la Fuente 1994, p. 484)
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: Insufficient information to permit judgement of high or low risk of bias
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: Insufficient information on how blinding of patients was carried out and maintained to permit a judgement of low or high risk of bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "The study was carried out by two clinicians. One of them [...] was blind to the drug treatment and performed all the clinical and psychometric assessments. [...] We instructed the patients to not communicate side effects to the blind clinician." (De la Fuente 1994, p. 480)
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "Of the 20 patients enrolled in the trial, we randomized 10 into the CBZ group and 10 received PLC. [...] Two patients receiving CBZ dropped out. [...] No patient on PLC dropped out." (De la Fuente 1994, p. 481)
Comment: Reasons for early termination specified (De la Fuente 1994, p. 481):
dramatic increase in frequency and intensity of aggression (against self and others): 2 in carbamazepine group, 0 in placebo group
However, it remained unclear if the reported continuous outcomes were measured by LOCF analyses. We decided to use the same numbers of patients for which dichotomous outcomes were reported. For dichotomous outcomes, lacking numbers of patients were imputed as having the unfavourable results.
Selective reporting (reporting bias) Unclear risk Comment: no protocol found
Vested Interest (funding and/or author affiliations) Unclear risk Comment: authors affiliated with Department of Psychiatry, Erasme Hospital, Free University, Brussels. No details about funding or sponsoring provided
Other bias Low risk Comment: No apparent other sources of bias found