Pramipexole in depression - a follow-up study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Skane

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

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

Trial duration

21 Apr 2023 → ongoing

Decision date (initial)

2023-02-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Craaford Foundation · Södra sjukvårdsregionen · ALF · Olle Engkvist Foundation · Brain Foundation · Swedish Research Council

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To investigate efficacy and tolerability of long-term add-on pramipexole in anhedonic depression

Conditions and MedDRA coding

Depression

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Previous participation in RCT testing the short-term efficacy of pramipexole vs placebo (EudraCT# 2022-001563-26).
2. Study participants randomized to pramipexole in the RCT who wish to continue with their treatment can enrol in the study.
3. Study participants randomized to placebo in the RCT who fulfil the inclusion criteria after the RCT can enrol in the study.
4. The research subject has given informed consent to participate in the study.
5. Additional inclusion criterion for patients receiving placebo during the RCT: Anhedonia symptoms: 3 or 4 points on ≥ 3 items of the Snaith-Hamilton Pleasure Scale (SHAPS-C). This has been adopted in previous studies as a definition of "clinically significant anhedonia"27.

Exclusion criteria 15

1. Pregnancy, breastfeeding or planned pregnancy (if female).
2. High suicide risk according to the overall clinical assessment of the research physician.
3. Ongoing substance abuse (within 6 months).
4. Diagnosis of current psychosis.
5. Known diagnosis of Emotionally Unstable Personality Disorder.
6. Treatment under LPT.
7. History of or a strong clinical suspicion of impulse control disorder (including current binge-eating disorder) or a current ADHD diagnosis with hyperactivity.
8. Diagnosis of intellectual disability, dementia, or other circumstance that makes it difficult to understand the meaning of participating in the trial and give informed consent.
9. Diagnosis of renal failure (eGFR < 50 ml/min/1.73m2) or severe cardiovascular disease (specifically symptomatic heart failure NYHA Class II or higher). Blood samples from RCT are sufficient to rule this out.
10. Recently started psychotherapy (within 6 weeks).
11. Ongoing or planned ECT, ketamine or rTMS treatment, excluding maintenance ECT, ketamine or rTMS. (Maintenance treatment is defined as the use of ECT/ketamine/rTMS for a period exceeding 3 months after a series of ECT/ketamine/rTMS treatment in order to prevent the onset of a new episode).
12. Other medical conditions or other concomitant drug treatment (see section 13.5) which, in the opinion of the investigators, may affect the evaluability of the trial or conditions that increase trial risk. For example, Parkinson's disease, hepatic insufficiency, ongoing cancer not in remission for more than one year, older bariatric surgery with a known impact on absorption of extended-release tablets.
13. Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.
14. Participation in other treatment studies.
15. Other reason, as assessed by the investigator, that prevents the research subject's participation, such as the risk that the research subject is unable to complete the trial (non-compliance).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Total SHAPS-C scores

Secondary endpoints 6

1. HDRS6 scores
2. Number of steps/day, movement pattern distribution over the day, walking distance, time spent in light, moderate and intense physical activity, resting heart rate, blood oxygen saturation, heart rate variability (stress scores), sleep latency (time to fall asleep), sleep awakening (how often you wake up during the night), wakefulness (time in minutes awake during a night), time in deep sleep, sleep efficiency (time asleep vs. total time in bed).
3. Total scores of DARS, MADRS-S, Insomnia Severity Scale, AES, GAD-7 and BBQ.
4. Adverse events and side effects
5. fMRI, blood and CSF biomarkers from the RCT as treatment predictors.
6. Neuropsychological test battery consisting of WAIS-IV, RBANS, D-KEFS, CPT-3 and cognitive self-assessment PDQ-5.

Investigational products

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

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Skane

Sponsor organisation

Region Skane

Address

Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri

City

Malmo

Postcode

211 74

Country

Sweden

Scientific contact point

Organisation

Region Skane

Contact name

Daniel Lindqvist

Public contact point

Organisation

Region Skane

Contact name

Daniel Lindqvist

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 14 files

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

Application history

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