Trial Outcomes & Findings for Pramipexole to Target "Anhedonic Depression" (NCT NCT04121091)

NCT ID: NCT04121091

Last Updated: 2025-12-12

Results Overview

Change in anhedonia symptoms (total score on the DARS). The range is 0-68, lower score indicating more severe anhedonia.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: baseline to week 10
• Results posted on: 2025-12-12

Participant Flow

Patients were recruited from outpatient clinics in Lund, Sweden. All study visits were conducted via the adult psychiatric clinic in Lund, Baravägen 1, 221 85, Lund during the period 4 Oct 2019 - 18 Mar 2021.

12 patients with unipolar or bipolar, moderate-to-severe, depression were assigned to active open-label treatment with pramipexole. The sample was enriched for significant anhedonia symptoms, enrolling only patients with a score of <27 on the Dimensional Anhedonia Rating Scale (DARS, inverse scale). 1 dropout pre-assignment/pre-treatment.

Participant milestones

Measure	Pramipexole Active treatment, open-label, with the dopamine agonist pramipexol individually titrated to highest tolerable dose (max 4,5 mg salt) daily. Administration: tablets orally.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pramipexole to Target "Anhedonic Depression"

Baseline characteristics by cohort

Measure	Pramipexole n=12 Participants 12 patients
Age, Continuous	45 Years STANDARD_DEVIATION 16 • n=26 Participants
Sex: Female, Male Female	8 Participants n=26 Participants
Sex: Female, Male Male	4 Participants n=26 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=26 Participants
Race (NIH/OMB) Asian	0 Participants n=26 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=26 Participants
Race (NIH/OMB) Black or African American	0 Participants n=26 Participants
Race (NIH/OMB) White	12 Participants n=26 Participants
Race (NIH/OMB) More than one race	0 Participants n=26 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=26 Participants
Region of Enrollment Sweden	12 Participants n=26 Participants
Tobacco users	5 Participants n=26 Participants
hsCRP	3.8 mg/L STANDARD_DEVIATION 4.7 • n=26 Participants
Concurrent pharmacological treatment SSRI users	5 Participants n=26 Participants
Concurrent pharmacological treatment SNRI users	6 Participants n=26 Participants
Concurrent pharmacological treatment NDRI users	2 Participants n=26 Participants
Concurrent pharmacological treatment Antipsychotics users	0 Participants n=26 Participants
Concurrent pharmacological treatment Mood stabilizers users	2 Participants n=26 Participants
ECT	4 Participants n=26 Participants
Anxiety comorbidity	6 Participants n=26 Participants
Number of previous antidepressants	5 Number of different antidepressants n=26 Participants

PRIMARY outcome

Timeframe: baseline to week 10

Change in anhedonia symptoms (total score on the DARS). The range is 0-68, lower score indicating more severe anhedonia.

Outcome measures

Measure	Pramipexole n=12 Participants Pramipexole Pill: Add-on pramipexole
Dimensional Anhedonia Rating Scale (DARS) Score DARS total score baseline	15.75 score on a scale Standard Deviation 6.440
Dimensional Anhedonia Rating Scale (DARS) Score DARS total score week 10	33.08 score on a scale Standard Deviation 11.782

SECONDARY outcome

Timeframe: baseline to week 10

Montgomery Åsberg Depression Rating Scale (MADRS). The range is 0-60, lower score indicating less general depressive symptoms.

Response definition: reduction of at least 50% Remission definition: MADRS total score equal to or below 10

Outcome measures

Measure	Pramipexole n=12 Participants Pramipexole Pill: Add-on pramipexole
Response Responders	4 Participants
Response Non-responders	8 Participants

SECONDARY outcome

Timeframe: baseline to week 10

Change in depression symptoms (total score on the MADRS). The range is 0-60, lower score indicating less general depressive symptoms.

Outcome measures

Measure	Pramipexole n=12 Participants Pramipexole Pill: Add-on pramipexole
Montgomery Åsberg Depression Rating Scale (MADRS) Score MADRS total score baseline	26.33 score on a scale Standard Deviation 4.185
Montgomery Åsberg Depression Rating Scale (MADRS) Score MADRS total score week 10	15.67 score on a scale Standard Deviation 6.401

SECONDARY outcome

Timeframe: baseline to week 10

Change in anhedonia symptoms (total score on the Snaith-Hamilton Anhedonia Pleasure Scale) score 0-1-2-3. Range 0-32. Higher score indicating more intense anhedonic symptoms.

Outcome measures

Measure	Pramipexole n=12 Participants Pramipexole Pill: Add-on pramipexole
Snaith-Hamilton Anhedonia Pleasure Scale SHAPS total score baseline	30.00 score on a scale Standard Deviation 5.592
Snaith-Hamilton Anhedonia Pleasure Scale SHAPS total score week 10	17.50 score on a scale Standard Deviation 6.389

SECONDARY outcome

Timeframe: baseline to week 10

Change in anxiety symptoms (total score on the the Generalized Anxiety Disorder-7 scale = GAD-7). Range 0-21. Higher score indicating more anxiety.

Outcome measures

Measure	Pramipexole n=12 Participants Pramipexole Pill: Add-on pramipexole
Generalized Anxiety Disorder-7 GAD-7 total score week 10	6.18 score on a scale Standard Deviation 6.570
Generalized Anxiety Disorder-7 GAD-7 total score baseline	9.64 score on a scale Standard Deviation 6.087

SECONDARY outcome

Timeframe: baseline to week 10

Change in insomnia symptoms (total score on the the Insomnia Severity Index scale = ISI). Range 0-28. Higher score indicating more insomnia symptoms.

Outcome measures

Measure	Pramipexole n=11 Participants Pramipexole Pill: Add-on pramipexole
Insomnia Severity Index ISI total score baseline	15.73 score on a scale Standard Deviation 6.182
Insomnia Severity Index ISI total score week 10	10.27 score on a scale Standard Deviation 4.839

SECONDARY outcome

Timeframe: baseline to week 10

Change in fatigue symptoms (total score on the the Fatigue Severity scale = FSS). Range 9-63. Higher score indicating more fatigue.

Outcome measures

Measure	Pramipexole n=11 Participants Pramipexole Pill: Add-on pramipexole
Fatigue Severity Scale FSS total score baseline	46.45 score on a scale Standard Deviation 12.581
Fatigue Severity Scale FSS total score week 10	38.45 score on a scale Standard Deviation 15.807

SECONDARY outcome

Timeframe: baseline to week 10

Change in apathy symptoms (total score on the the The Apathy Evaluation Scale = AES). Range 0-54. Higher score indicating more severe apathy.

Outcome measures

Measure	Pramipexole n=11 Participants Pramipexole Pill: Add-on pramipexole
The Apathy Evaluation Scale AES total score baseline	52.55 score on a scale Standard Deviation 6.905
The Apathy Evaluation Scale AES total score week 10	36.18 score on a scale Standard Deviation 9.152

SECONDARY outcome

Timeframe: baseline to week 10

The investigators will measure blood levels of Interleukin-6 (IL-6), C-reactive protein (CRP), Tumor Necrosis Factor Alpha (TNF), and White Blood Cell count (WBC) at baseline and at study completion. The investigators will test if baseline levels and treatment-associated change in inflammatory markers can predict treatment response

Outcome measures

Measure	Pramipexole n=12 Participants Pramipexole Pill: Add-on pramipexole
Change in Inflammatory Biomarkers CRP at baseline	3.8 mg/L Standard Deviation 4.7
Change in Inflammatory Biomarkers CRP at week 10	2.6 mg/L Standard Deviation 3.5

SECONDARY outcome

Timeframe: baseline to week 10 (and baseline data as potential predictor)

fMRI = functional magnetic resonance tomography. Structural imaging, followed by resting-state functional imaging, diffusion tensor imaging and thereafter the MID (monetary incentive delay) task.

Outcome measures

Measure	Pramipexole n=12 Participants Pramipexole Pill: Add-on pramipexole
Participation in fMRI With MID-task Not participating in fMRI	4 Participants
Participation in fMRI With MID-task Participating in fMRI	8 Participants

Adverse Events

Pramipexole

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pramipexole n=12 participants at risk Pramipexole Pill: Add-on pramipexole
General disorders Headache	83.3% 10/12 • For each participant, adverse event data was collected for 14 weeks: every week for 10 weeks and an additional check-up at week 14. According to EU regulation 536/2014 (Clinical Trials Regulation, CTR).
General disorders Nausea	75.0% 9/12 • For each participant, adverse event data was collected for 14 weeks: every week for 10 weeks and an additional check-up at week 14. According to EU regulation 536/2014 (Clinical Trials Regulation, CTR).
General disorders Fatigue	25.0% 3/12 • For each participant, adverse event data was collected for 14 weeks: every week for 10 weeks and an additional check-up at week 14. According to EU regulation 536/2014 (Clinical Trials Regulation, CTR).
Skin and subcutaneous tissue disorders Skin rashes	25.0% 3/12 • For each participant, adverse event data was collected for 14 weeks: every week for 10 weeks and an additional check-up at week 14. According to EU regulation 536/2014 (Clinical Trials Regulation, CTR).
Metabolism and nutrition disorders Loss of appetite	16.7% 2/12 • For each participant, adverse event data was collected for 14 weeks: every week for 10 weeks and an additional check-up at week 14. According to EU regulation 536/2014 (Clinical Trials Regulation, CTR).
General disorders Vertigo	16.7% 2/12 • For each participant, adverse event data was collected for 14 weeks: every week for 10 weeks and an additional check-up at week 14. According to EU regulation 536/2014 (Clinical Trials Regulation, CTR).
Psychiatric disorders Depressed mood	8.3% 1/12 • For each participant, adverse event data was collected for 14 weeks: every week for 10 weeks and an additional check-up at week 14. According to EU regulation 536/2014 (Clinical Trials Regulation, CTR).
Psychiatric disorders Agitation (mild)	8.3% 1/12 • For each participant, adverse event data was collected for 14 weeks: every week for 10 weeks and an additional check-up at week 14. According to EU regulation 536/2014 (Clinical Trials Regulation, CTR).
Psychiatric disorders Overeating	8.3% 1/12 • For each participant, adverse event data was collected for 14 weeks: every week for 10 weeks and an additional check-up at week 14. According to EU regulation 536/2014 (Clinical Trials Regulation, CTR).
Cardiac disorders Palpitations	8.3% 1/12 • For each participant, adverse event data was collected for 14 weeks: every week for 10 weeks and an additional check-up at week 14. According to EU regulation 536/2014 (Clinical Trials Regulation, CTR).
Psychiatric disorders Mania	0.00% 0/12 • For each participant, adverse event data was collected for 14 weeks: every week for 10 weeks and an additional check-up at week 14. According to EU regulation 536/2014 (Clinical Trials Regulation, CTR).

Additional Information

Dr Daniel Lindqvist

Unit of Biological and Precision Psychiatry

Phone: +4646173885

Email: daniel.lindqvist@med.lu.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place