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Pramipexole to Target "Anhedonic Depression" (PILOT-PRAXOL)

Primary Purpose

Depression, Bipolar, Depression, Unipolar, Dysthymia

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Pramipexole Pill

About this trial

This is an interventional treatment trial for Depression, Bipolar

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 and ≤75.
Diagnosis of unipolar depression; bipolar disorder in depressive phase or dysthymia.
Symptoms of depression; Total-score ≥ 18, measured by Montgomery-Åsberg Depression Rating Scale (MADRS).
Symptoms of anhedonia; Total-score < 27, measured by Dimensional Anhedonia Rating Scale (DARS).
Ongoing treatment with at least one antidepressant drug ≥ 4 weeks without major changes in dosage. Patients with bipolar disorder must have a mood-stabilizing drug treatment.
Must sign an informed consent. -

Exclusion Criteria:

Ongoing pregnancy, breastfeeding or planning for pregnancy.
High suicidality assessed by the researcher with medical degree.
Ongoing substance use disorder (last 12 month).
Diagnosis of psychosis.
Ongoing involuntary psychiatric treatment.
History of Impulse-control disorder or current ADHD diagnosis.
Diagnosis of Intellectual disability, dementia, or other circumstances leading to difficulties to understand the implications of participating in the study and to give informed consent.
Diagnosis of renal failure (eGFR < 50 ml/min/1,73 m2 ) or severe cardiovascular disease (defined as symptoms of heart failure NYHA class 2).
Recently committed to psychotherapy (during the last 6 weeks) or planning for psychotherapy during the participation of the study.
Ongoing ECT-treatment.
Other diseases, disorders or medical treatments that according to the researchers might influence the results of the study or increases the risks of the study. Such as Parkinson's disorder, liver failure, cancer not in remission (for at least over a year).
Confirmed or suspected allergy to the active substance or excipients of the drug used in this study.
Committed to other trials
Other reasons that according to the researcher might prevent the subject to fulfill the obligations of the study. For example insufficient drug compliance. -

Sites / Locations

Psychiatry Clinic, Lund, Region Skåne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pramipexole

Arm Description

Outcomes

Primary Outcome Measures

Dimensional Anhedonia Rating Scale (DARS) score

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

Secondary Outcome Measures

Response/remission

Montgomery Åsberg Depression Rating Scale (MADRS) reduction 50%, MADRS ≤ 10 respectively

Montgomery Åsberg Depression Rating Scale (MADRS) score

Change in depression symptoms (total score on the MADRS)

Snaith-Hamilton Anhedonia Pleasure Scale

Change in anhedonia symptoms (total score on the Snaith-Hamilton Anhedonia Pleasure Scale)

the Motivation and Pleasure Scale

Change in motivation/anhedonia symptoms (total score on the the Motivation and Pleasure Scale)

Generalized Anxiety Disorder-7

Change in anxiety symptoms (total score on the the Generalized Anxiety Disorder-7 scale)

Insomnia Severity Index

Change in insomnia symptoms (total score on the the Insomnia Severity Index scale)

Fatigue Severity Scale

Change in fatigue symptoms (total score on the the Fatigue Severity scale)

The Apathy Evaluation Scale

Change in apathy symptoms (total score on the the The Apathy Evaluation Scale)

Change in inflammatory biomarkers

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

Change in brain imaging parameters

Structural imaging, followed by resting-state functional imaging, diffusion tensor imaging and thereafter the monetary incentive delay task

Full Information

NCT ID

NCT04121091

First Posted

October 4, 2019

Last Updated

September 14, 2021

Sponsor

Region Skane

Collaborators

Lund University

1. Study Identification

Unique Protocol Identification Number

NCT04121091

Brief Title

Pramipexole to Target "Anhedonic Depression"

Acronym

PILOT-PRAXOL

Official Title

Pramipexole Augmentation to Target Anhedonia in Depression - a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

October 4, 2019 (Actual)

Primary Completion Date

March 18, 2021 (Actual)

Study Completion Date

March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Region Skane

Collaborators

Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The heterogeneity of depression suggests that different neurocircuits and pathophysiological mechanisms are involved. Anhedonia - the inability to experience pleasure from, or the lack of motivation to carry out, usually enjoyable activities - is an endophenotype within the depression spectrum, with a distinct pathophysiology of dopaminergic mesolimbic projections. Anhedonia is common in depression and associated with treatment resistance. Pramipexole, an agonist to the dopamine -receptor 3, is an established treatment of Parkinson's disease. Based on its mechanism of action, pramipexole might be efficacious in a subtype of depression characterized by anhedonia and lack of motivation - symptoms linked to dopaminergic hypofunction. In this proof-of-concept pilot study the investigators test the anti-anhedonic and antidepressant effects of add-on pramipexole using an "enriched population study design" including only depressed patients with significant anhedonia. To understand the neurobiology of anhedonia in depression and to identify treatment predictors, the investigators also do assessments of anhedonia-related neurocircuitry using (f)MRI and blood biomarkers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Bipolar, Depression, Unipolar, Dysthymia, Anhedonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pramipexole

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Pramipexole Pill

Intervention Description

Add-on pramipexole

Primary Outcome Measure Information:

Title

Dimensional Anhedonia Rating Scale (DARS) score

Description

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

Time Frame

baseline to week 10

Secondary Outcome Measure Information:

Title

Response/remission

Description

Montgomery Åsberg Depression Rating Scale (MADRS) reduction 50%, MADRS ≤ 10 respectively

Time Frame

baseline to week 10

Title

Montgomery Åsberg Depression Rating Scale (MADRS) score

Description

Change in depression symptoms (total score on the MADRS)

Time Frame

baseline to week 10

Title

Snaith-Hamilton Anhedonia Pleasure Scale

Description

Change in anhedonia symptoms (total score on the Snaith-Hamilton Anhedonia Pleasure Scale)

Time Frame

baseline to week 10

Title

the Motivation and Pleasure Scale

Description

Change in motivation/anhedonia symptoms (total score on the the Motivation and Pleasure Scale)

Time Frame

baseline to week 10

Title

Generalized Anxiety Disorder-7

Description

Change in anxiety symptoms (total score on the the Generalized Anxiety Disorder-7 scale)

Time Frame

baseline to week 10

Title

Insomnia Severity Index

Description

Change in insomnia symptoms (total score on the the Insomnia Severity Index scale)

Time Frame

baseline to week 10

Title

Fatigue Severity Scale

Description

Change in fatigue symptoms (total score on the the Fatigue Severity scale)

Time Frame

baseline to week 10

Title

The Apathy Evaluation Scale

Description

Change in apathy symptoms (total score on the the The Apathy Evaluation Scale)

Time Frame

baseline to week 10

Title

Change in inflammatory biomarkers

Description

Time Frame

baseline to week 10

Title

Change in brain imaging parameters

Description

Structural imaging, followed by resting-state functional imaging, diffusion tensor imaging and thereafter the monetary incentive delay task

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 and ≤75. Diagnosis of unipolar depression; bipolar disorder in depressive phase or dysthymia. Symptoms of depression; Total-score ≥ 18, measured by Montgomery-Åsberg Depression Rating Scale (MADRS). Symptoms of anhedonia; Total-score < 27, measured by Dimensional Anhedonia Rating Scale (DARS). Ongoing treatment with at least one antidepressant drug ≥ 4 weeks without major changes in dosage. Patients with bipolar disorder must have a mood-stabilizing drug treatment. Must sign an informed consent. - Exclusion Criteria: Ongoing pregnancy, breastfeeding or planning for pregnancy. High suicidality assessed by the researcher with medical degree. Ongoing substance use disorder (last 12 month). Diagnosis of psychosis. Ongoing involuntary psychiatric treatment. History of Impulse-control disorder or current ADHD diagnosis. Diagnosis of Intellectual disability, dementia, or other circumstances leading to difficulties to understand the implications of participating in the study and to give informed consent. Diagnosis of renal failure (eGFR < 50 ml/min/1,73 m2 ) or severe cardiovascular disease (defined as symptoms of heart failure NYHA class 2). Recently committed to psychotherapy (during the last 6 weeks) or planning for psychotherapy during the participation of the study. Ongoing ECT-treatment. Other diseases, disorders or medical treatments that according to the researchers might influence the results of the study or increases the risks of the study. Such as Parkinson's disorder, liver failure, cancer not in remission (for at least over a year). Confirmed or suspected allergy to the active substance or excipients of the drug used in this study. Committed to other trials Other reasons that according to the researcher might prevent the subject to fulfill the obligations of the study. For example insufficient drug compliance. -

Facility Information:

Facility Name

Psychiatry Clinic, Lund, Region Skåne

City

Lund

ZIP/Postal Code

22358

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

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Pramipexole to Target "Anhedonic Depression"

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