Trial · NCT04121091

Pramipexole to Target "Anhedonic Depression"

NCT04121091, Phase 2, Completed, Region Skane; results first posted 2025-12-12

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Pramipexole to Target "Anhedonic Depression". Trials, record NCT04121091. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04121091

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pramipexole to Target "Anhedonic Depression"
NCT number: NCT04121091
Status: Completed
Phases: Phase 2
Enrollment: 13 participants, actual
Lead sponsor: Region Skane
Conditions: Depression, Bipolar, Depression, Unipolar, Dysthymia, Anhedonia
Interventions: Pramipexole Pill
First posted: 2019-10-09
Last updated: 2025-12-12
Results first posted: 2025-12-12
Limitations and caveats: Inherent limitations and caveats of this test-of-feasibility study: small-scale (small sample) and open-label design.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Dimensional Anhedonia Rating Scale (DARS) Score	baseline to week 10	Change in anhedonia symptoms (total score on the DARS). The range is 0-68, lower score indicating more severe anhedonia.
Secondary	Response	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
Secondary	Montgomery Åsberg Depression Rating Scale (MADRS) Score	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.
Secondary	Snaith-Hamilton Anhedonia Pleasure Scale	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.
Secondary	Generalized Anxiety Disorder-7	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.
Secondary	Insomnia Severity Index	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.
Secondary	Fatigue Severity Scale	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.
Secondary	The Apathy Evaluation Scale	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.
Secondary	Change in Inflammatory Biomarkers	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
Secondary	Participation in fMRI With MID-task	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.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Dimensional Anhedonia Rating Scale (DARS) Score	baseline to week 10	score on a scale	MEAN
SECONDARY	Response	baseline to week 10	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Montgomery Åsberg Depression Rating Scale (MADRS) Score	baseline to week 10	score on a scale	MEAN
SECONDARY	Snaith-Hamilton Anhedonia Pleasure Scale	baseline to week 10	score on a scale	MEAN
SECONDARY	Generalized Anxiety Disorder-7	baseline to week 10	score on a scale	MEAN
SECONDARY	Insomnia Severity Index	baseline to week 10	score on a scale	MEAN
SECONDARY	Fatigue Severity Scale	baseline to week 10	score on a scale	MEAN
SECONDARY	The Apathy Evaluation Scale	baseline to week 10	score on a scale	MEAN
SECONDARY	Change in Inflammatory Biomarkers	baseline to week 10	mg/L	MEAN
SECONDARY	Participation in fMRI With MID-task	baseline to week 10 (and baseline data as potential predictor)	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Dimensional Anhedonia Rating Scale (DARS) Score	Pramipexole	DARS total score baseline	15.75	Standard Deviation 6.440	score on a scale
Dimensional Anhedonia Rating Scale (DARS) Score	Pramipexole	DARS total score week 10	33.08	Standard Deviation 11.782	score on a scale
Response	Pramipexole	Responders	4		Participants
Response	Pramipexole	Non-responders	8		Participants
Montgomery Åsberg Depression Rating Scale (MADRS) Score	Pramipexole	MADRS total score baseline	26.33	Standard Deviation 4.185	score on a scale
Montgomery Åsberg Depression Rating Scale (MADRS) Score	Pramipexole	MADRS total score week 10	15.67	Standard Deviation 6.401	score on a scale
Snaith-Hamilton Anhedonia Pleasure Scale	Pramipexole	SHAPS total score baseline	30.00	Standard Deviation 5.592	score on a scale
Snaith-Hamilton Anhedonia Pleasure Scale	Pramipexole	SHAPS total score week 10	17.50	Standard Deviation 6.389	score on a scale
Generalized Anxiety Disorder-7	Pramipexole	GAD-7 total score baseline	9.64	Standard Deviation 6.087	score on a scale
Generalized Anxiety Disorder-7	Pramipexole	GAD-7 total score week 10	6.18	Standard Deviation 6.570	score on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pramipexole	12
Overall Study	COMPLETED	Pramipexole	12
Overall Study	NOT COMPLETED	Pramipexole	0

Source ClinicalTrials.gov

Adverse events11

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	General disorders	Pramipexole	10	12
other	Nausea	General disorders	Pramipexole	9	12
other	Fatigue	General disorders	Pramipexole	3	12
other	Skin rashes	Skin and subcutaneous tissue disorders	Pramipexole	3	12
other	Loss of appetite	Metabolism and nutrition disorders	Pramipexole	2	12
other	Vertigo	General disorders	Pramipexole	2	12
other	Depressed mood	Psychiatric disorders	Pramipexole	1	12
other	Agitation (mild)	Psychiatric disorders	Pramipexole	1	12
other	Overeating	Psychiatric disorders	Pramipexole	1	12
other	Palpitations	Cardiac disorders	Pramipexole	1	12

1 to 10 of 11Source ClinicalTrials.gov

See all 11 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pramipexole	0	12
Total, other adverse events	Pramipexole	12	12
Total, serious adverse events	Pramipexole	0	12

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Monetary Incentive Delay	Secondary outcome

Source ConductCognition

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT04121091/registered

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