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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Toulouse

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2024-10-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The main objective of this pilot study is to evaluate on day 9, in patients with severe borderline personality disorder (BPD), the evolution of the intensity of BPD symptoms (BSL) after the administration of two doses of Ketamine by IV infusion ( 0.5 mg/kg at 0 and 24 hours) in combination with the recommended first level care.

Secondary objectives 6

1. Evaluate after IV administration of two doses of Ketamine: 1. the evolution of the intensity of the symptoms of borderline personality disorder, using the BSL-23 self-evaluation scale at different times (baseline, D3, M1, M3)
2. 2. the evolution of the intensity of symptoms of borderline personality disorder, using a hetero-evaluative scale (Zanarini-BPD) at different times (baseline, D3, M1 and M3)
3. 3. the evolution of suicidal ideation at different times (baseline, D3, D9, M1 and M3)
4. 4. the evolution of depressive symptoms at different times (baseline, D3, D9, M1 and M3)
5. 5. seeking care for worsening symptoms of borderline personality disorder between D9 and M3: new hospitalizations and visits to the emergency room
6. 6. drug safety of use in this population

Conditions and MedDRA coding

borderline personality disorder

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Adult patient aged 18 to 65
2. Free, informed and written consent
3. Fluency in French
4. Diagnosis of borderline personality disorder according to DSM5 MINI criteria (5 out of 9 criteria)
5. Severe borderline personality disorder: BSL-23 score > or= 1.9 (“high” symptoms severity)
6. Patient having a background pharmacological treatment (antipsychotic, mood stabilizer, anti-depressant) and/or non-pharmacological (schema therapy, DBT) stable for four weeks
7. Person affiliated to or beneficiary of a social security system.

Exclusion criteria 15

1. lifetime diagnosis or episode of psychotic disorder for the participant or for a first degree relative
2. Protection measure for property and the person in progress (protection of justice, curatorship, guardianship)
3. Pregnant or breastfeeding woman
4. History of a manic or hypomanic episode
5. current severe depressive episode: MADRS > 35 before inclusion
6. ketamine abuse (ketamine taken several times a week)
7. Family history (first degree family) of psychotic disorder
8. long-term treatment (antidepressant, antipsychotic, thymoregulator) or specific intervention for BDP introduced in the previous four weeks
9. current prescription of MAOIs
10. specific absolute contraindication to ketamine: severe failure, stroke/TIA within the previous year, uncontrolled hypertension(BP>140/90), known hypersensitivity to ketamine, known Brugada syndrome or Major ECG abnormality (QTc>450ms)
11. Major ECG abnormality (corrected QT > 450 ms; ST segment abnormalities)
12. Cirrhosis or history of major disturbance in liver function tests (AST or ALT >2N or bilirubin >1,5 N)
13. hepatic or cutaneous porphyria
14. Participation in another interventional study involving humans or being in the exclusion period following previous research if applicable
15. Any reason clinically significant at inclusion baseline wich in the opinion of the investigator could compromise the safety of the participant

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 6

1. Difference in the intensity of BPD symptoms measured by the BSL-23 scale between baseline and different times (H48, M1, M3)
2. Difference in the intensity of BPD symptoms measured by the Zanarini-BPD scale between baseline and different times (H48, D9, M1, M3)
3. Difference in the intensity of suicidal ideation measured by the C-SSRS scale between baseline and different times (H48, D9, M1, M3)
4. Difference in the intensity of depressive symptoms measured by the MADRS scale between baseline and different times (H48, D9, M1, M3)
5. 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)
6. Collection of all serious and non-serious adverse events, in particular those attributed to ketamine

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Toulouse

Sponsor organisation

Centre Hospitalier Universitaire De Toulouse

Address

2 Rue Viguerie

City

Toulouse

Postcode

31300

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

Dr Gaël GALLIOT

Public contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

Amandine PAUZE

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications