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

Linehan 2008.

Study characteristics
Methods 24‐week trial with 2 arms:

  1. DBT + olanzapine

  2. DBT + placebo


Duration: 24 weeks
Country: USA
Setting: outpatient
Participants Methods of recruitment of patients: no information
Overall sample size: 24
Diagnosis of borderline personality disorder: DSM‐IV
Means of assessment: SCID‐II
Mean age: 36.8 years (SD 9.0; range = no information)
Sex: 100% women
Comorbidity: no information
Inclusion criteria

  1. BPD according to DSM‐IV (SCID‐II, IPDE)

  2. BPD criterion for inappropriate anger met

  3. Score of 6 or higher on the irritability scale of the Overt Agression Scale Modified (OAS‐M)


Exclusion criteria

  1. Episode of self‐inflicted self‐injury, including suicide attempts during 8 weeks prior to screening

  2. Current diagnosis of schizophrenia, bipolar I disorder, schizoaffective disorder, major depressive disorder with psychotic features or other psychotic disorder

  3. Substance dependence during last 6 months

  4. Mental retardation

  5. Seizure disorder

  6. Pregnant women or women planning to become pregnant

  7. Breastfeeding
Interventions Experimental group
Treatment name: olanzapine (2.5‐15 mg/d, mean final dose 4.46, SD 1.16)
Number randomised to group: 12
Duration: 6 months
Control/comparison group
Comparison name: placebo
Number randomised to group: 12
Duration: 6 months
Both groups
Concomitant psychotherapy: All participants received DBT.
Concomitant pharmacotherapy: no information
Proportions of participants taking standing medication during trial observation period: no information
Outcomes Primary outcomes

  1. Suicidal ideation, measured in terms of number of patients with a high suicidality score on the OAS‐M Suicidality subscale. Assessed at baseline, week 7, 14 and 21 (EOT)

  2. Self‐mutilating behaviour, measured in terms of number of patients with self‐injury


Secondary outcomes

  1. Depression, measured by Ham‐D. Assessed at baseline, week 7, 14 and 21 (EOT)

  2. Attrition

  3. Adverse effects, measured by weight gain (lb); remaining data on adverse effects not usable
Notes Sample calculation: no information
Ethics approval: no information
Funding source: funded or partially funded by pharmaceutical industry
Conflicts of interest: Dr Linehan is a consultant for Eli Lilly and is a member of their speakers/advisory board.
Comments from trial authors (limitations): "A limitation to this study is the small sample size". (Linehan 2008, p. 1004)
Comments from review authors: data refer to the intention‐to‐treat sample.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "random number sequence" (Linehan 2008, p. e2)
Allocation concealment (selection bias) Unclear risk Comment: Insufficient information on allocation concealment to permit judgement of low or high risk of bias
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: Insufficient information on how blinding of participants and personnel was secured and maintained (e.g. packaging of trial medication) to permit judgement of low or high risk of bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Patients, psychotherapists, pharmacotherapist, and assessment interviewers were kept naive to medication assignment. At the end of the study, the pharmacotherapist and interviewers were unable to guess group assignment above chance." (Linehan 2008, p. e2)
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "Outcomes were intent‐to‐treat analyses". (Linehan 2008, p. e3)
Comment: Reasons for early termination specified (Linehan 2008, p. e4); patients who had dropped out were imputed as having the negative outcome.
Selective reporting (reporting bias) Unclear risk Comment: no protocol found
Vested Interest (funding and/or author affiliations) High risk Quote: "This research was supported by a grant from Eli Lilly and Co., Protocol F1D‐US‐X173, to Dr. Linehan; by Remind Rx Medication Compliance Systems; and by a contribution of electronic pill bottles from IBV Technologies, Seattle, Wash. [...]. Dr. Linehan is a consultant for, has received grant/research support and honoraria from, and is a member of the speakers/advisory board for Eli Lilly. Drs. McDavid, Brown, Sayrs, and Gallop report no additional financial or other relationships relevant to the subject of this article." (Linehan 2008, p. 999)
Other bias Low risk Comment: no indication of other bias