search
Back to results

Dose-finding Study With Lu AA24530 in Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lu AA24530
Duloxetine
Placebo
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Drug therapy, Depressive disorder, Antidepressive agents, Depressive symptoms, Affective disorders, Randomized controlled trial, Placebo-controlled, Double-blind, Active reference, Multicenter study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Major Depressive Episode that has lasted at least 3 months
  • Moderate to severe depression

Exclusion Criteria:

  • Any current psychiatric disorder established as the principal diagnosis other than MDD as defined in the DSM-IV-TR and as assessed with the Mini-International Neuropsychiatric Interview (MINI)
  • Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR
  • Major Depressive Episode that has been unresponsive to two adequate courses of antidepressant treatment, each of at least 6 weeks duration
  • Electroconvulsive therapy within 6 months prior to Baseline
  • Ongoing formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study
  • Clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
  • The patient is pregnant or breast-feeding

Sites / Locations

  • AU002
  • AU001
  • AU003
  • AU004
  • AU006
  • AT001
  • AT002
  • AT003
  • BE003
  • BE002
  • CA006
  • CA004
  • CA003
  • CA005
  • CA001
  • CZ002
  • CZ005
  • CZ001
  • CZ004
  • CZ003
  • CZ006
  • FI001
  • FI003
  • FI006
  • FI004
  • FI005
  • FI002
  • FR007
  • FR002
  • FR003
  • FR001
  • FR008
  • FR004
  • FR005
  • IN001
  • IN009
  • IN007
  • IN006
  • IN003
  • IN002
  • KR003
  • KR002
  • KR001
  • LT002
  • LT003
  • LT001
  • MY002
  • MY003
  • NO004
  • NO001
  • NO003
  • PH002
  • PH003
  • PH001
  • RU005
  • RU002
  • RU004
  • RU003
  • RU001
  • RS004
  • RS002
  • SE006
  • SE001
  • SE002
  • SE003
  • SE005
  • SE004
  • UA003
  • UA005
  • UA002
  • UA004
  • UA001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Lu AA24530: 5 mg

Lu AA24530: 10 mg

Lu AA24530: 20 mg

Duloxetine: 60 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score

Secondary Outcome Measures

Response rate, remission rate, and safety

Full Information

First Posted
December 28, 2007
Last Updated
November 7, 2016
Sponsor
H. Lundbeck A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT00599911
Brief Title
Dose-finding Study With Lu AA24530 in Major Depressive Disorder
Official Title
Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo
Detailed Description
According to the World Health Organisation, Major Depressive Disorder is the leading cause of disability and the 4th leading contributor to the global burden of disease. There are unmet medical needs in the treatment of depressive disorders in terms of insufficient effectiveness and unpleasant side-effects of current therapies. The overall prognosis of the disorder is positive for the majority of patients, but as many as 30% of patients will develop a chronic and treatment-resistant depression. In the study, patients with depression are treated for 6 weeks. Assessments of efficacy and safety are taking place every week for the first 4 weeks and again after 6 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Drug therapy, Depressive disorder, Antidepressive agents, Depressive symptoms, Affective disorders, Randomized controlled trial, Placebo-controlled, Double-blind, Active reference, Multicenter study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
652 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lu AA24530: 5 mg
Arm Type
Experimental
Arm Title
Lu AA24530: 10 mg
Arm Type
Experimental
Arm Title
Lu AA24530: 20 mg
Arm Type
Experimental
Arm Title
Duloxetine: 60 mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lu AA24530
Intervention Description
per oral, once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
per oral, once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
per oral, once daily for 6 weeks
Primary Outcome Measure Information:
Title
The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Response rate, remission rate, and safety
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major Depressive Episode that has lasted at least 3 months Moderate to severe depression Exclusion Criteria: Any current psychiatric disorder established as the principal diagnosis other than MDD as defined in the DSM-IV-TR and as assessed with the Mini-International Neuropsychiatric Interview (MINI) Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR Major Depressive Episode that has been unresponsive to two adequate courses of antidepressant treatment, each of at least 6 weeks duration Electroconvulsive therapy within 6 months prior to Baseline Ongoing formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study Clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance The patient is pregnant or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
AU002
City
Brisbane
ZIP/Postal Code
4000
Country
Australia
Facility Name
AU001
City
Brisbane
ZIP/Postal Code
4053
Country
Australia
Facility Name
AU003
City
Dandenc
ZIP/Postal Code
3175
Country
Australia
Facility Name
AU004
City
Epping
ZIP/Postal Code
3076
Country
Australia
Facility Name
AU006
City
Malvern
ZIP/Postal Code
3144
Country
Australia
Facility Name
AT001
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
AT002
City
Vienna
Country
Austria
Facility Name
AT003
City
Vienna
Country
Austria
Facility Name
BE003
City
Diest
ZIP/Postal Code
2930
Country
Belgium
Facility Name
BE002
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
CA006
City
Mississauga
ZIP/Postal Code
L5M 4N4
Country
Canada
Facility Name
CA004
City
Oakville
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
CA003
City
Penticton
ZIP/Postal Code
V2A 4M4
Country
Canada
Facility Name
CA005
City
Toronto
ZIP/Postal Code
M4S 1Y2
Country
Canada
Facility Name
CA001
City
Vancouver
ZIP/Postal Code
V6Z 2L4
Country
Canada
Facility Name
CZ002
City
Brno
ZIP/Postal Code
60200
Country
Czech Republic
Facility Name
CZ005
City
Praha 2
ZIP/Postal Code
12000
Country
Czech Republic
Facility Name
CZ001
City
Praha 5
ZIP/Postal Code
15030
Country
Czech Republic
Facility Name
CZ004
City
Praha 5
ZIP/Postal Code
158 00
Country
Czech Republic
Facility Name
CZ003
City
Praha 6
ZIP/Postal Code
16000
Country
Czech Republic
Facility Name
CZ006
City
Sternberk
ZIP/Postal Code
78517
Country
Czech Republic
Facility Name
FI001
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
Facility Name
FI003
City
Helsinki
ZIP/Postal Code
00530
Country
Finland
Facility Name
FI006
City
Järvenpää
Country
Finland
Facility Name
FI004
City
Seinäjoki
Country
Finland
Facility Name
FI005
City
Tampere
Country
Finland
Facility Name
FI002
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
FR007
City
Angouleme
ZIP/Postal Code
16000
Country
France
Facility Name
FR002
City
Dole
ZIP/Postal Code
39100
Country
France
Facility Name
FR003
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
FR001
City
Orvault
ZIP/Postal Code
44700
Country
France
Facility Name
FR008
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
FR004
City
Savigny sur Orge
ZIP/Postal Code
91600
Country
France
Facility Name
FR005
City
Wattigny
ZIP/Postal Code
59139
Country
France
Facility Name
IN001
City
Ahmedabab
Country
India
Facility Name
IN009
City
Ahmedabad
Country
India
Facility Name
IN007
City
Chennai
ZIP/Postal Code
3
Country
India
Facility Name
IN006
City
Hyderabaad
ZIP/Postal Code
500 034
Country
India
Facility Name
IN003
City
Mangalore
ZIP/Postal Code
574160
Country
India
Facility Name
IN002
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
KR003
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
KR002
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
KR001
City
Seoul
ZIP/Postal Code
138-746
Country
Korea, Republic of
Facility Name
LT002
City
Kaunas
ZIP/Postal Code
50185
Country
Lithuania
Facility Name
LT003
City
Klaipeda
ZIP/Postal Code
91251
Country
Lithuania
Facility Name
LT001
City
Vilnius
Country
Lithuania
Facility Name
MY002
City
Kuala Lumpur
ZIP/Postal Code
55100
Country
Malaysia
Facility Name
MY003
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
NO004
City
Fredrikstad
ZIP/Postal Code
1606
Country
Norway
Facility Name
NO001
City
Hamar
ZIP/Postal Code
2315
Country
Norway
Facility Name
NO003
City
Skien
ZIP/Postal Code
3725
Country
Norway
Facility Name
PH002
City
Las Pinas
ZIP/Postal Code
1701
Country
Philippines
Facility Name
PH003
City
Mandaluyong City
Country
Philippines
Facility Name
PH001
City
Mandaue City
ZIP/Postal Code
6014
Country
Philippines
Facility Name
RU005
City
Arkhangelsk
ZIP/Postal Code
163061
Country
Russian Federation
Facility Name
RU002
City
Nikolskoe
ZIP/Postal Code
188357
Country
Russian Federation
Facility Name
RU004
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
RU003
City
St-Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
RU001
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Facility Name
RS004
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
RS002
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
SE006
City
Halmstad
ZIP/Postal Code
301 85
Country
Sweden
Facility Name
SE001
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
SE002
City
Lund
ZIP/Postal Code
223 61
Country
Sweden
Facility Name
SE003
City
Malmö
ZIP/Postal Code
21237
Country
Sweden
Facility Name
SE005
City
Stockholm
ZIP/Postal Code
112 34
Country
Sweden
Facility Name
SE004
City
Uppsala
ZIP/Postal Code
753 19
Country
Sweden
Facility Name
UA003
City
Dnepropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
UA005
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
UA002
City
Kyiv
ZIP/Postal Code
4080
Country
Ukraine
Facility Name
UA004
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
UA001
City
Odessa
ZIP/Postal Code
65006
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
32242018
Citation
Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Theroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5.
Results Reference
derived
PubMed Identifier
31087825
Citation
Belzeaux R, Fiori LM, Lopez JP, Boucekine M, Boyer L, Blier P, Farzan F, Frey BN, Giacobbe P, Lam RW, Leri F, MacQueen GM, Milev R, Muller DJ, Parikh SV, Rotzinger S, Soares CN, Uher R, Foster JA, Kennedy SH, Turecki G. Predicting Worsening Suicidal Ideation With Clinical Features and Peripheral Expression of Messenger RNA and MicroRNA During Antidepressant Treatment. J Clin Psychiatry. 2019 May 7;80(3):18m12556. doi: 10.4088/JCP.18m12556.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
EMA EudraCT Results
Available IPD/Information URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001071-11/results
Available IPD/Information Identifier
2007-001071-11

Learn more about this trial

Dose-finding Study With Lu AA24530 in Major Depressive Disorder

We'll reach out to this number within 24 hrs