Gardner 1986.

Methods	Design: placebo‐controlled cross‐over trial
Participants	Participants: women with borderline personality disorder and extensive history of behavioural dyscontrol Sex: female only Age: mean 31.7 years; range 23 to 42 years Unit of allocation: individual participant Number randomised: 16 Number completing: 11 Setting: outpatient; USA (Maryland) Inclusion criteria: meeting DSM‐III criteria for BPD (average of 6.7 criteria met); meeting DIB criteria for BPD (average scale score 8.9);  extensive history of behavioural dyscontrol (see note 1) Exclusion criteria: DSM‐III diagnosis of schizophrenia, major depressive disorder, or alcoholism or substance abuse disorder Ethnicity: not reported Baseline characteristics: recurrent rage episodes (88%), multiple overdoses (69%), multiple episodes of self‐burning (19%), multiple wrist, arm or abdomen cuts (56%), episodes of violence (44%), previous suicide attempt with intention of dying (56%), history of episodes of major depression (50%)
Interventions	Two conditions: carbamazepine / placebo (see note 2)  carbamazepine (n = 11 for paired comparisons (see note 3); n = 14 for independent comparisons); 200 to 1200 mg/day adjusted according to therapeutic effectiveness, side effects and blood levels (8 to 12 μg/ml); average daily dose = 820 mg; average length carbamazepine treatment = 32.6 days  placebo (n = 11 for paired comparisons (see note 3); n = 11 for independent comparisons); average length placebo administration = 29.4 days  Duration of intervention: 6 weeks Duration of trial: 14 weeks (cross‐over trial; 2 phases for carbamazepine/placebo comparison, 1‐week dose tapering, then 1‐week washout period between phases) Length of follow up: participants were not followed up beyond the end of the intervention period Dose adjustment: initial 2‐week dose adjustment period, followed by 4 weeks of steady dose administration
Outcomes	Primary outcomes Aggression (self‐reported): individual data, plus ratings of behaviour dyscontrol incidents (see note 4) Secondary outcomes Anger: numbers with angry outbursts Non‐compliance: Attrition data? Other outcomes Ratings of mood (no results presented)
Notes	1. Although an extensive history of behavioural dyscontrol was an inclusion criterion, it is unclear whether every subject had demonstrated episodes of either rage or violence. Nonetheless, those that may not will have experienced episodes of aggression to the self (self‐harm). 2. Participants randomly assigned to carbamazepine/placebo as part of a cross‐over study involving 4 active medications plus placebo 3. Data from the 11 paired comparisons are considered in this review 4. Here, ‘behaviour dyscontrol incidents’ includes aggressive acts and angry outbursts, but also suicide attempts and gestures and incidents of self‐harm
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Investigators report that “the trials were randomized to avoid any sequence effects” (p.520 col. 1). No further details given. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared.
Allocation concealment?	Unclear risk	No details reported. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared.
Blinding? of participants	Low risk	Investigators describe the study as “a double‐blind cross‐over trial” (Abstract) and report that “the patients and physicians, who were blind to the medication, met weekly . . .” (p.520 col. 1). Review authors judge that blinding of participants was adequate and that it was unlikely that this blinding could have been broken.
Blinding? of personnel	Low risk	Investigators describe the study as “a double‐blind cross‐over trial” (Abstract) and report that “the patients and physicians, who were blind to the medication, met weekly . . .” (p.520 col. 1). Review authors judge that blinding of personnel was adequate and that it was unlikely that this blinding could have been broken.
Blinding? of outcome assessors	Low risk	Investigators describe the study as “a double‐blind cross‐over trial” (Abstract) and report that “the patients and physicians, who were blind to the medication, met weekly to complete ratings of mood and behavior” (p.520 col. 1). Review authors judge that blinding of outcome assessors was adequate and that it was unlikely that this blinding could have been broken.
Incomplete outcome data addressed? All outcomes	Unclear risk	In this cross‐over trial, 5/16 missing at completion of intervention (6 weeks). Two participants excluded by investigators (1 due to a seizure during rapid alprazolam withdrawal, 1 due to requiring adjunctive thioridazine). Three participants dropped out after completing a carbamazepine phase but not a placebo phase (reasons not given). Insufficient information to decide if reasons for missing outcome data likely to be related to true outcome. Trial investigators report a completer analysis on the 11 that had completed both phases. In this review, data from 11 participants were included in the analysis.
Free of selective reporting?	Low risk	Reported as part of the complete study involving cross‐over trials with placebo and 4 active medications (only one of which was an antiepileptic). This study was limited to: “the preliminary findings regarding behavioral dyscontrol during the carbamazepine and placebo trials” (p.520 col. 1). Thus focus was on behaviour and not mood states, and so absence of mood results (mood ratings) was not relevant. Thus although study protocol is not available, it seems clear that the published report includes all expected outcomes, including those that were pre‐specified.
Free of other bias?	Unclear risk	An extensive history of behavioural dyscontrol (which the investigators take to include self‐harm) was an inclusion criterion for this study. The study is included in this review since the participants were not recruited solely on the basis of having self‐harmed. However, it is possible that 2 of the participants had not demonstrated episodes of either rage or violence and so may not have been aggressive other than to themselves. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared. The study appeared to be free of other sources of bias, and the trial investigators report a 1‐week placebo washout period between phases in this cross‐over trial which will have reduced the possibility of carryover effects.