Ketamine therapy in obsessive-compulsive disorder and its effects on neuropsychological function under stress in a cross-over trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

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

Trial duration

25 Aug 2022 → ongoing

Decision date (initial)

2024-10-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Vienna Medical University

External identifiers

EU CT number

2024-518212-40-00

EudraCT number

2021-003228-34

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Test the efficacy of ketamine in obsessive-compulsive disorder

Conditions and MedDRA coding

Obsessive Compulsive Disorder (OCD)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Primary diagnosis of obsessive-compulsive disorder
2. A score of 16 or higher on the Yale-Brown Obsessive- Compulsive Scale
3. Age of at least 18 years and ability to provide written informed consent
4. At least one previous treatment for OCD

Exclusion criteria 13

1. Any history of current or past psychotic disorder
2. A manic episode within the preceding three years
3. Current or unstable remitted substance abuse or dependence except nicotine
4. Pregnancy or elevated risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception
5. Any current severe personality disorder except comorbid anankastic personality disorder
6. Current unstable suicidality
7. Morbus Raynaud
8. Unstable hypertension
9. Any other severe and unstable cardiovascular disease -
10. Untreated hyperthyroidism
11. Untreated disorders severely affecting the HPA-axis (M.Addison, M.Cushing)
12. Current pharmacological therapy severely affecting the HPA- axis like corticosteroids or ACTH
13. Inability to follow the study protocol or adhere to operational requirements

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Difference of changes in YBOCS scores before and 7 days after ketamine infusion compared midazolam infusion, tested in an intention to treat set.

Secondary endpoints 9

1. Difference of changes in OCD-VAS scores between period specific baseline and 24h after ketamine infusion compared to midazolam infusion, tested in a per protocol set.
2. Difference of changes in YBOCS scores between period specific baseline and 24h after ketamine infusion compared to midazolam infusion, tested in a per protocol set.
3. Difference between areas under the curve of OCD-VAS, over the course of 7 days, starting with ketamine and midazolam infusion, respectively, tested in a per protocol set. 5)
4. Difference of changes in neuropsychological function under stress between baseline and 24 hours post ketamine and midazolam infusion, respectively, measured by WCST, SSRT, N-back and ToH, tested in a per protocol set.
5. Difference of changes of hormonal stress response between study baseline and 24 hours post ketamine compared to midazolam infusion, measured by salivary cortisol levels, summarized as an AUC for each period, tested in a per protocol set.
6. Difference of changes of vegetative stress response between study baseline and 24 hours post ketamine compared to midazolam infusion, measured by blood pressure, heart rate and subjective stress VAS scores, summarized as an AUC for each period, tested in a per protocol set.
7. Difference of OCD-VAS scores a month after open-label treatment compared to treatment as usual, tested in a per protocol set.
8. Difference of YBOCS scores a month after open-label treatment compared to treatment as usual, tested in a per protocol set.
9. Distinct changes in EEG frequency bands during ketamine infusion compared to midazolam.

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Psychiatry and Psychotherapy, Division of General Psychiatry

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Psychiatry and Psychotherapy, Division of General Psychiatry

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 8 files

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

Application history

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