Long-term Efficacy of Pramipexole in Anhedonic Depression

NCT05825235 | Completed Phase 3

• 1 other identifier: 2022-502270-17-00
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the long-term efficacy and safety of add-on pramipexole for treatment of patients with anhedonic depression.

Conditions

Anhedonia; Depression

Keywords

anhedonia; depression; dopamine; pramipexole

Outcome Measures

Primary Outcomes (7)

• Anhedonia symptoms

  Total Snaith Hamilton Anhedonia Pleasure (SHAPS) self-report scale scores. Higher scores equal more severe anhedonoa. Score range 14-56

  Baseline

• Anhedonia symptoms

  Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

  Month 1

• Anhedonia symptoms

  Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

  Month 2

• Anhedonia symptoms

  Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

  Month 3

• Anhedonia symptoms

  Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

  Month 4

• Anhedonia symptoms

  Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

  Month 5

• Anhedonia symptoms

  Total SHAPS self-report scores. Higher scores equal more severe anhedonoa. Score range 14-56

  Month 6

Secondary Outcomes (64)

• Core depression symptoms

  baseline

• Core depression symptoms

  Month 1

• Core depression symptoms

  Month 2

• Core depression symptoms

  Month 3

• Core depression symptoms

  Month 4

Study Arms (1)

Pramipexole

EXPERIMENTAL

Pramipexole prolonged-release tablet with doses ranging from 0.26 mg base to 3.15 mg base / day, study duration 6 months

Drug: Pramipexole

Interventions

Pramipexole DRUG

6 months of treatment with add-on Pramipexole

Pramipexole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous participation in RCT testing the short-term efficacy of pramipexole vs placebo (EudraCT# 2022-001563-26).
• Study participants randomized to pramipexole in the RCT who wish to continue with their treatment can enrol in the study.

You may not qualify if:

• The research subject has given informed consent to participate in the study.
• 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".
• Pregnancy, breastfeeding or planned pregnancy (if female).
• High suicide risk according to the overall clinical assessment of the research physician.
• Ongoing substance abuse (within 6 months).
• Diagnosis of current psychosis.
• Known diagnosis of Emotionally Unstable Personality Disorder.
• Treatment under LPT.
• History of impulse control disorder (including current binge-eating disorder) or a current ADHD diagnosis with hyperactivity.
• 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.
• Diagnosis of renal failure or severe cardiovascular disease (specifically symptomatic heart failure NYHA Class II). Blood samples from RCT are sufficient to rule this out.
• Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial.
• Ongoing 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).
• Other medical conditions or other concomitant drug treatment (see section 14.5) 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, gastric bypass surgery that affects the absorption of extended release tablets.
• Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Region Skåne

Lund, Skåne County, 221 85, Sweden

Location

Related Publications (1)

• Lindahl J, Asp M, Stahl D, Tjernberg J, Eklund M, Bjorkstrand J, van Westen D, Jensen J, Mansson K, Tornberg A, Svensson M, Deierborg T, Ventorp F, Lindqvist D. Add-on pramipexole for anhedonic depression: study protocol for a randomised controlled trial and open-label follow-up in Lund, Sweden. BMJ Open. 2023 Nov 30;13(11):e076900. doi: 10.1136/bmjopen-2023-076900.

  PMID: 38035737 DERIVED

MeSH Terms

Conditions

Anhedonia; Depression

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Not masked.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within the frame of the previous RCT study (Eudra CT 2022-001563-26) approximately 50% of the participants have been treated with the study product and 50% with placebo. In this study all participants receive the study product, so some will continue their ongoing treatment with the study product and some will start using the study product.

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 24, 2023
• Study Start: April 21, 2023
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

SE (1)