Ketamine infusion for symptomatological improvement of severe borderline personality disorder: a pilot study

Conditions

borderline personality disorder

Brief summary

Our primary outcome measures the difference of BPD symptoms’s intensity at BSL-23 (self-rated scale) from baseline to D9

Detailed description

Difference in the intensity of BPD symptoms measured by the BSL-23 scale between baseline and different times (H48, M1, M3), Difference in the intensity of BPD symptoms measured by the Zanarini-BPD scale between baseline and different times (H48, D9, M1, M3), Difference in the intensity of suicidal ideation measured by the C-SSRS scale between baseline and different times (H48, D9, M1, M3), Difference in the intensity of depressive symptoms measured by the MADRS scale between baseline and different times (H48, D9, M1, M3), a. Number of new hospitalizations in Psychiatry department (declarative measure, from D9 to M3) b. Number of visits to psychiatric emergencies (declarative measure, from D9 to M3), Collection of all serious and non-serious adverse events, in particular those attributed to ketamine

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGKETAMINE RENAUDIN 10 mg/ml

DRUGsolution injectable

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Our primary outcome measures the difference of BPD symptoms’s intensity at BSL-23 (self-rated scale) from baseline to D9	—

Secondary

Measure	Time frame
Difference in the intensity of BPD symptoms measured by the BSL-23 scale between baseline and different times (H48, M1, M3), Difference in the intensity of BPD symptoms measured by the Zanarini-BPD scale between baseline and different times (H48, D9, M1, M3), Difference in the intensity of suicidal ideation measured by the C-SSRS scale between baseline and different times (H48, D9, M1, M3), Difference in the intensity of depressive symptoms measured by the MADRS scale between baseline and different times (H48, D9, M1, M3), a. Number of new hospitalizations in Psychiatry department (declarative measure, from D9 to M3) b. Number of visits to psychiatric emergencies (declarative measure, from D9 to M3), Collection of all serious and non-serious adverse events, in particular those attributed to ketamine	—

Measure

Time frame

Difference in the intensity of BPD symptoms measured by the BSL-23 scale between baseline and different times (H48, M1, M3), Difference in the intensity of BPD symptoms measured by the Zanarini-BPD scale between baseline and different times (H48, D9, M1, M3), Difference in the intensity of suicidal ideation measured by the C-SSRS scale between baseline and different times (H48, D9, M1, M3), Difference in the intensity of depressive symptoms measured by the MADRS scale between baseline and different times (H48, D9, M1, M3), a. Number of new hospitalizations in Psychiatry department (declarative measure, from D9 to M3) b. Number of visits to psychiatric emergencies (declarative measure, from D9 to M3), Collection of all serious and non-serious adverse events, in particular those attributed to ketamine

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Countries

France

Outcome results

None listed