The DEXA-PSYCH Study: Dexamethasone Repurposing for Moderate to Severe Depression - A Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Hovedstadens Psykiatriske

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

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

Trial duration

28 Dec 2022 → ongoing

Decision date (initial)

2022-10-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Mental Health Services of The Capital Region of Denmark ("Region Hovedstadens Psykiatri") · The Novo Nordisk Foundation

External identifiers

EU CT number

2022-501428-45-00

WHO UTN

U1111-1280-7614

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The objective of the DEXA-PSYCH trial is to test the efficacy and safety of dexamethasone, a well-tolerated glucocorticoid, as add-on to treatment as usual (TAU) in treatment of moderate to severe depression.

Conditions and MedDRA coding

Depression

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Diagnosis of non-psychotic, moderate to severe depressive disorder (single episode or recurrent) by a medical doctor according to ICD-10 criteria (ICD-10 codes: F32.1, F32.2, F33.1, F33.2) as operationalized in the Schedule for Clinical Assessment in Neuropsychiatry (SCAN), Section 6-8
2. A score of 22 or above on the MADRS10 scale at day 0
3. Age between 18 and 64 years (both included) at the date of enrollment
4. Habile (i.e. able to give informed consent)
5. Speaks Danish fluently
6. Are currently receiving pharmacological treatment for depression

Exclusion criteria 17

1. Have a known hypersensitivity to glucocorticoid treatment (including any drug in the glucocorticoid class) either explicitly stated in the patient journal or known to the patient from prior glucocorticoid treatment
2. Have a known 1st degree family history of bipolar disorder (i.e. among parents, siblings and children)
3. Are diagnosed with disorders that are listed as contra-indications for glucocorticoid treatment in Danish guidelines including immunodeficiencies, systemic fungal infections, active tuberculosis, hematological malignancies, epilepsy, myasthenia gravis, ocular herpes simplex, pheochromocytoma, systemic sclerosis or acute coronary syndrome (within the last 6 months)
4. Have prolonged QTc-interval on ECG (>480 ms)
5. Have clinically significant reduction in liver function (ALT >2.5 x upper limit of normal range, ULN: men >70 U/l, women >45 U/l)
6. Have diagnosed diabetes mellitus or suspected diabetes mellitus (as measured by HbA1c of >45 mmol/mol)
7. Have suicidal plans
8. Have undergone electroconvulsive treatment (ECT) or transcranial magnetic stimulation (TMS) within the last 2 weeks
9. Have been vaccinated within 14 days before intervention initiation or is planning on being vaccinated during the intervention or within 14 days after the vaccination
10. Are currently undergoing treatment with potassium-depleting diuretics
11. Are currently undergoing immunosuppressive treatments or treatments affecting the CYP3A4 system (i.e. erythromycin, itraconazole, ritonavir, lopinavir, phenobarbital, phenytoin, rifampicin)
12. Have undergone treatment with monoamine oxidase (MAO) inhibitors in the last 14 days
13. Are pregnant (i.e. fertile woman below 60 with a positive urine or plasma human gonadotropin test), currently breast-feeding or not adherent to a sufficient anticontraceptive plan
14. Are undergoing or have undergone systemic (oral or intravenous) treatment with any drug in the glucocorticoid class within the last 14 days
15. Have previously been diagnosed with a psychotic disorder (including depression with psychotic symptoms), personality disorder, eating disorder or bipolar disorder
16. Have experienced or are experiencing manic and/or hypomanic episodes as uncovered according to section 10 of the SCAN assessment
17. Are currently using psychoactive substances and fulfill ICD-10 criteria for harmful use (F1X.1) or dependence syndrome (F1X.2.)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline (day 0) on the Montgomery-Asberg Depression Rating Scale (MADRS-10) at day 7.

Secondary endpoints 23

1. Number of participants with remission (MADRS10 score less than or equal to 10) on day 7
2. Change in quality of life as measured by change from baseline (day 0) on the EQ-5D-5L on day 7.
3. Safety outcomes (ARs (including SARs) occurring on or before day 10, all-cause discontinuation, vital signs, suicidal ideation (C-SSRS, day 7), laboratory tests, ECG, toxicity (GTI, day 7), side-effects of antidepressant (UKU-SSRI, day 7), positive psychotic symptoms (SAPS, day 7), manic symptoms (YMRS, day 7), admission (somatic and psychiatric, day 28), suicide attempts and completed suicides (day 28), all-cause mortality (day 28)
4. Change from baseline (day 0) on the MADRS10 at day 4, 14 and 28.
5. Change from baseline (day 0) on the Hamilton Depression Rating Scale (HAM-D17) on day 7 and 28.
6. Change in quality of life as measured by change from baseline (day 0) on the EQ-5D-5L on day 28 and at 6-months follow up.
7. Change in suicidal ideation as measured by change from baseline (day 0) on the Columbia-Suicide Severity Rating Scale (C-SSRS) on day 28 and at 6-months follow up.
8. Number of participants with remission (MADRS10 score less than or equal to 10) at 6-month follow up.
9. Relative risk of being unemployed or on full time sick leave at day 7, day 28 and at 6-months follow-up (as assessed through patient interviews) as well as beyond (as assessed through national Danish registers).
10. Relative risk of admissions due to psychiatric illness before 6-months follow-up (as assessed through patient interview and electronic health records) as well as beyond (as assessed through national Danish registers).
11. Relative risk of suicide attempts before 6-months follow-up (as assessed through patient interview and electronic health records) as well as beyond (as assessed through national Danish registers).
12. All-cause mortality at 6-months follow-up (as assessed through electronic health records) as well as beyond (as assessed through national Danish registers).
13. Change in anxiety symptoms as measured by change from baseline (day 0) on the Hamilton Anxiety Rating Scale (HAM-A) on day 7, 28 and at 6 months follow-up.
14. Change in functioning as measured by change from baseline (day 0) on the Global Assessment of Functioning (GAF) scale on day 7, 28 and at 6 months follow-up.
15. Change from baseline (day 0) on MDI on day 7 and 28 and at 6-months follow-up.
16. Baseline levels of CRP and leucocytes in responders and non-responders as well as other biochemical markers assayed in biological samples.
17. General level of physical and social activity as measured in the Monsenso app day 1- 28
18. Change in fatigue as measured by change from baseline (day 0) on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale on day 7, 28 and at 6 months follow up.
19. Number of participants with response (MADRS10 score <50 % of the score at day 0) on day 7
20. Change from baseline (day 0) on the MADRS10 at 6-months follow up.
21. 8. Change from baseline (day 0) on the MADRS6 (at day 4, 7, 14, 28 and at 6-months follow up) and HAM-D6 (at day 7, 28 and at 6-months follow up).
22. Self-rated MADRS scores on day 1-28 based on data collection in the Monsenso app.
23. Sustained response. Number of participants with response (MADRS10 score <50 % of the score at day 0) both on day 7 and subsequently also on days 14 and 28.

Investigational products

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

Test 1

Placebo 1

Auxiliary 10

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstadens Psykiatriske

Sponsor organisation

Region Hovedstadens Psykiatriske

Address

Nordre Ringvej 69

City

Glostrup

Postcode

2600

Country

Denmark

Scientific contact point

Organisation

Region Hovedstadens Psykiatriske

Contact name

Michael Eriksen Benros

Public contact point

Organisation

Region Hovedstadens Psykiatriske

Contact name

Michael Eriksen Benros

Third parties 3

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 9 files

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

Application history

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