Clinical Trials Register

Summary
EudraCT Number:	2019-001907-19
Sponsor's Protocol Code Number:	PILOT-PREXOL
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-05-10
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Sweden - MPA

A.2

EudraCT number

2019-001907-19

A.3

Full title of the trial

Pramipexole augmentation to target anhedonia in depression - a pilot study

Tilläggsbehandling med Pramipexol mot anhedonisymptom vid depression - en pilotstudie

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Pramipexole augmentation to target anhedonia in depression - a pilot study

Tilläggsbehandling med Pramipexol mot anhedonisymptom vid depression - en pilotstudie

A.3.2

Name or abbreviated title of the trial where available

PILOT-PREXOL

A.4.1

Sponsor's protocol code number

PILOT-PREXOL

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Region Skåne
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	the Royal Physiographic Society of Lund
B.4.2	Country	Sweden
B.4.1	Name of organisation providing support	the Söderström-Königska Foundation
B.4.2	Country	Sweden
B.4.1	Name of organisation providing support	the province of Scania (Sweden) state grants (ALF)
B.4.2	Country	Sweden
B.4.1	Name of organisation providing support	SUS Donations & Foundations
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Region Skåne
B.5.2	Functional name of contact point	Vuxenpsykiatri Lund
B.5.3	Address:
B.5.3.1	Street Address	Baravägen 1
B.5.3.2	Town/ city	Lund
B.5.3.3	Post code	22240
B.5.3.4	Country	Sweden
B.5.6	E-mail	daniel.lindqvist@med.lu.se

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Pramipexole Orion
D.2.1.1.2	Name of the Marketing Authorisation holder	Orion Corporation
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Pramipexole Orion 0,26 mg, 0,52 mg, 1,05 mg and 2,1 mg
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Depression

E.1.1.1

Medical condition in easily understood language

Depression

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10002511
E.1.2	Term	Anhedonia
E.1.2	System Organ Class	10037175 - Psychiatric disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main objective is to test the efficacy of add-on pramipexole in treating anhedonia in patients with depression.

E.2.2

Secondary objectives of the trial

Secondary objectives are:

1. To investigate optimal dosing of pramipexole in order to treat anhedonia and at the same time avoid side effects
2. To test the efficacy of pramipexole to treat symptoms of fatigue, anxiety, sleep problems, and general depressive symptoms
3. To investigate an fMRI-paradigm testing the reward system (monetary incentive task) and inflammatory blood markers as predictors of pramipexole treatment response

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

One of the secondary objectives (nr 3) is to investigate an fMRI-paradigm testing the reward system (with the monetary incentive delay task, MID-task). Since this part of the study is not mandatory it is considered a sub-study. All subjects will be offered the opportunity to undergo an fMRI-scan including structural MR, diffusion tensor imaging, functional connectivity and lastly the MID-task. The purpose is to investigate if BOLD-activity during MID-task can predict treatment outcome of premipexole.

E.3

Principal inclusion criteria

1. Age ≥18 and ≤75.
2. Diagnosis of unipolar depression; bipolar disorder in depressive phase or dysthymia.
3. Symptoms of depression; Total-score ≥ 18, measured by Montgomery-Åsberg Depression Rating Scale (MADRS).
4. Symptoms of anhedonia; Total-score < 27, measured by Dimensional Anhedonia Rating Scale (DARS). (low scores equals high levels of anhedonia)
5. 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.
6. Must sign an informed consent.

E.4

Principal exclusion criteria

1. Ongoing pregnancy, breastfeeding or planning for pregnancy.
2. High suicidality assessed by the researcher with medical degree.
3. Ongoing substance use disorder (last 12 month).
4. Diagnosis of psychosis.
5. Ongoing involuntary psychiatric treatment.
6. History of Impulse-control disorder or current ADHD diagnosis.
7. 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.
8. Diagnosis of renal failure (eGFR < 50 ml/min/1,73 m2 ) or severe cardiovascular disease (defined as symptoms of heart failure NYHA class 2).
9. Recently committed to psychotherapy (during the last 6 weeks) or planning for psychotherapy during the participation of the study.
10. Ongoing ECT-treatment.
11. 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).
12. Confirmed or suspected allergy to the active substance or excipients of the drug used in this study.
13. Committed to other trials
14. Other reasons that according to the researcher might prevent the subject to fulfill the obligations of the study. For example insufficient drug compliance.

E.5 End points

E.5.1

Primary end point(s)

Absolute change in score on the Dimensional Anhedonia Rating Scale (DARS)

E.5.1.1

Timepoint(s) of evaluation of this end point

Every second week between from baseline to week 10

E.5.2

Secondary end point(s)

1. Absolute change in score on the Montgomery-Åsberg Rating Scale (MADRS), the Snaith–Hamilton Pleasure Scale (SHAPS), the Motivation and Pleasure Scale (MAP-SR), the General Anxiety Disorder-7 (GAD-7), the Fatigue Severity Scale (FSS), the Insomnia Severity Index (ISI), and the Apathy Evaluation Scale (AES).
2. Change in inflammatory markers over the treatment course
3. Optimal dosing interval and number of drop-outs
4. Change in fMRI BOLD-signal in the ventral striatum during the monetary incentive delay task pre/post pramipexole treatment

E.5.2.1

Timepoint(s) of evaluation of this end point

Every second week between from baseline to week 10 except blood inflammatory markera and fMRI (two time points - baseline and at week 10 when study is completed)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

During the final study visit at week 10, we will discuss whether the study participant would like to continue taking pramipexole. If yes, we will write a referral to their regular physician asking to take over responsibility for the medication. Whether or not the patients' regular physician is willing to do this will be discussed before study enrollment. If a patient need to taper the medication, this will be done according to the guidelines in FASS in to avoid discontinuation symptoms

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-06-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-03-18

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