Clinical Trials Register

Summary
EudraCT Number:	2009-010188-18
Sponsor's Protocol Code Number:	26859
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2010-06-17
Trial 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

Netherlands - Competent Authority

A.2

EudraCT number

2009-010188-18

A.3

Full title of the trial

Effectiveness of Transmural Collaborative care and Duloxetine for major depressive disorder and (sub)chronic pain: a randomized placebo-controlled Multi-Centre trial.

A.3.1

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

Effectiveness of the treatment of depressive disorder and comorbid pain symptoms

A.3.2

Name or abbreviated title of the trial where available

TCC: PAINDIP

A.4.1

Sponsor's protocol code number

26859

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	Eli Lilly Nederland
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Eli Lilly Nederland BV
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	GGz Breburg
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	Arkin
B.4.2	Country	Netherlands
B.4.1	Name of organisation providing support	GGz inGeest
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GGz Breburg
B.5.2	Functional name of contact point	Trial Information
B.5.3	Address:
B.5.3.1	Street Address	Lage Witsiebaan 4
B.5.3.2	Town/ city	Tilburg
B.5.3.3	Post code	5000 AT
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	318801 61555
B.5.5	Fax number	318801 61699
B.5.6	E-mail	c.vanderfeltz-cornelis@ggzbreburg.nl

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Cymbalta
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	duloxetine
D.3.2	Product code	Cymbalta
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DULOXETINE
D.3.9.1	CAS number	116539-59-4
D.3.9.2	Current sponsor code	26859
D.3.9.3	Other descriptive name	cymbalta
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	30 to 90
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	Yes
D.3.11.13.1	Other medicinal product type	placebo , no active substance

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Major depressive disorder (episode or recurrent), as principal DSM-IV diagnosis combined with (sub)chronic pain symptoms as defined bij score of >3 on BPI painlist for at least six weeks.

E.1.1.1

Medical condition in easily understood language

Depressive disorder and pain symptoms

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To establish effectiveness on severity of depression (measured by PHQ-9), of a closely monitored integrated intervention (TCCCL + duloxetine) for concomitant (sub)chronic pain and depression compared to TCCCL + placebo and compared to Duloxetine alone.

E.2.2

Secondary objectives of the trial

1) To establish cost effectiveness in terms of Quality of Adjusted Life Years (QALY) as measured by EuroQol-5 and SF-36 and costs measured by TIC-P;
2) and to establish improvement on pain in terms of Brief Pain Inventory (BPI);
of three compared interventions:
TCCCL + duloxetine
versus TCCCL + placebo
versus Duloxetine alone.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All the patients that are referred to the participating mental health centers are screened for depressive symptoms and pain complaints. Pain that has lasted 2 weeks or longer than expected is considered problematic and qualifies for treatment. This study will focus on patients with a depressive disorder and (sub)chronic pain complaints. Sub chronic pain is defined as pain of ≥ 6 weeks [je noemt eerder 2 weken – kan verwarrend zijn] and chronic pain is defined as pain with a duration of at least 12 weeks. Consecutive patients that present themselves at the special mental health outpatient clinic will be screened for MDD and concomitant pain of ≥ 6 weeks duration with a questionnaire.
This questionnaire will consist of the Patient Health Questionnaire depression sub-scale (PHQ-9) and the item on 'average pain' from the Brief Pain Inventory (BPI), that will be used as a screener for respectively depressive disorder and (sub)chronic pain symptoms. Also, the patient will receive an informed consent form with information about the study. Patients are eligible for the study if they have a score of 10 or more on the PHQ-9 and a score of 3 or more on the 'average pain' item of the BPI. When a patient screens positive on the questionnaires mentioned above, the patient will receive a telephonic interview in which a MINI interview will be administered in order to clinically confirm the diagnosis MDD and to confirm that the patient suffers from (sub)chronic pain. In that case, he or she will receive additional information about the treatment part of the study and will be asked if he or she is willing to participate. When the patient is willing to participate, the patient is included in the study. A baseline questionnaire with second informed consent form, for the treatment part of the study, will be sent to the patient’s home address or made available on a secured website

E.4

Principal exclusion criteria

Patients with pain for which by diagnostic medical assessment a structural and continuing physical cause has been found in terms of tissue damage, illness or otherwise, that requires treatment, such as pain due to cancer or recent post traumatic pain, are excluded from the study and advised to seek such treatment. Other exclusion criteria are:
*a PHQ-9 < 10 or a BPI score < 3,
*alcohol use >3 units a day or drug abuse or dependence in the last 6 months, defined as current use of any hard drugs or cannabis
*psychotic symptoms or use of antipsychotic medication that may influence perception of pain;
*use of St John’s wort (Hypericum Perforatum),
*pregnancy and breastfeeding,
*inability to participate in case of too severe language barrier,
*dementia
*severe renal and liver dysfunction.
* uncontrolled hypertension
*Lastly, suicidal ideation is an exclusion criterion if this constitutes immediate danger and the need for crisis management according to the consulted psychiatrist. This will be measured with the suicidal ideation item of the PHQ-9. For this purpose, a suicide protocol is used in the study, defining degrees of suicide risk and prescribing necessary steps to be taken to advert such risk.

E.5 End points

E.5.1

Primary end point(s)

50 % reduction at PHQ-9 score from baseline to study periods endpoint

E.5.1.1

Timepoint(s) of evaluation of this end point

Every 3 months for up to one year

E.5.2

Secondary end point(s)

50 % reduction at BPI score from baseline to study periods endpoint and cost-effectiveness

E.5.2.1

Timepoint(s) of evaluation of this end point

Every 3 months for up to one year

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

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

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

Yes

E.8.1.7.1

Other trial design description

open (3 conditions) AND dubbelblind (placebo)

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

see protocol

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

219

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

219

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

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

219

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)

See protocol

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

2010-07-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-11-19

P. End of Trial
P.	End of Trial Status	Ongoing

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