Major Depressive DisorderPhase 2NCT00599911
Dose-finding Study With Lu AA24530 in Major Depressive Disorder
A Phase 2 study testing Lu AA24530 and Duloxetine in people with Major Depressive Disorder, run by H. Lundbeck A/S at 72 sites in 17 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Lu AA24530 and Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 652 participants
- Where
- 72 sitesin 17 countries
- Study dates
- Oct 2007to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depressive Episode that has lasted at least 3 months
- Moderate to severe depression
Who cannot join
- 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
Trial locations and contacts
72 sites in 17 countries.
72 sites in 17 countries
France7 sites
FR007
Angoulême, 16000
FR002
Dole, 39100
FR003
Montpellier, 34000
FR001
Orvault, 44700
FR008
Rouen, 76000
FR004
Savigny-sur-Orge, 91600
FR005
Wattigny, 59139
Czechia6 sites
CZ002
Brno, 60200
CZ005
Prague, 12000
CZ001
Prague, 15030
CZ004
Prague, 158 00
CZ003
Prague, 16000
CZ006
Sternberk, 78517
Finland6 sites
FI001
Helsinki, 00260
FI003
Helsinki, 00530
FI006
Jarvenpaa
FI004
Seinäjoki
FI005
Tampere
FI002
Turku, 20100
India6 sites
IN001
Ahmedabab
IN009
Ahmedabad
IN007
Chennai, 3
IN006
Hyderabaad, 500 034
IN003
Mangalore, 574160
IN002
Pune, 411004
Sweden6 sites
SE006
Halmstad, 301 85
SE001
Linköping, 581 85
SE002
Lund, 223 61
SE003
Malmö, 21237
SE005
Stockholm, 112 34
SE004
Uppsala, 753 19
Australia5 sites
AU002
Brisbane, 4000
AU001
Brisbane, 4053
AU003
Dandenc, 3175
AU004
Epping, 3076
AU006
Malvern, 3144
Canada5 sites
CA006
Mississauga, L5M 4N4
CA004
Oakville, L6J 7W5
CA003
Penticton, V2A 4M4
CA005
Toronto, M4S 1Y2
CA001
Vancouver, V6Z 2L4
Russia5 sites
RU005
Arkhangelsk, 163061
RU002
Nikol'skoye, 188357
RU003
Saint Petersburg, 190005
RU004
Saratov, 410028
RU001
Tomsk, 634014
Ukraine5 sites
UA003
Dnipro, 49005
UA005
Kharkiv, 61068
UA002
Kyiv, 4080
UA004
Lviv, 79021
UA001
Odesa, 65006
Philippines3 sites
PH002
Las Piñas, 1701
PH003
Mandaluyong
PH001
Mandaue City, 6014
South Korea3 sites
KR003
Gwangju, 501-757
KR002
Seoul, 120-752
KR001
Seoul, 138-746
About this study
Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder
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
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Lu AA24530, Duloxetine, Placebo
- Keywords
- Drug therapy, Depressive disorder, Antidepressive agents, Depressive symptoms, Affective disorders, Randomized controlled trial, Placebo-controlled, Double-blind, Active reference, Multicenter study
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Depression, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AA24530Drug
per oral, once daily for 6 weeks
DuloxetineDrug
per oral, once daily for 6 weeks
PlaceboDrug
per oral, once daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lu AA24530: 5 mg | Experimental | Not described Receives: Drug: Lu AA24530 |
| Lu AA24530: 10 mg | Experimental | Not described Receives: Drug: Lu AA24530 |
| Lu AA24530: 20 mg | Experimental | Not described Receives: Drug: Lu AA24530 |
| Duloxetine: 60 mg | Active comparator | Not described Receives: Drug: Duloxetine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score
Measured: 6 weeks
Secondary outcomes (1)
Response rate, remission rate, and safety
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599911
- Sponsor's protocol ID
- 11918A
- Other IDs
- 2007-001071-11
- Status last verified
- Nov 2016
- First submitted
- 28 Dec 2007
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32242018Belzeaux 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.
PubMed 31087825
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00599911
- Acronym / sponsor ID
- 11918A
- Conditions
- Major Depressive Disorder
- Keywords
- Drug therapy, Depressive disorder, Antidepressive agents, Depressive symptoms, Affective disorders, Randomized controlled trial, Placebo-controlled, Double-blind
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lu AA24530: 5 mg | Experimental | Drug: Lu AA24530 |
| Lu AA24530: 10 mg | Experimental | Drug: Lu AA24530 |
| Lu AA24530: 20 mg | Experimental | Drug: Lu AA24530 |
| Duloxetine: 60 mg | Active comparator | Drug: Duloxetine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major Depressive Episode that has lasted at least 3 months
- Moderate to severe depression
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AA24530per oral, once daily for 6 weeks | Drug | Lu AA24530: 10 mg, Lu AA24530: 20 mg, Lu AA24530: 5 mg |
| Duloxetineper oral, once daily for 6 weeks | Drug | Duloxetine: 60 mg |
| Placeboper oral, once daily for 6 weeks | Drug | Placebo |
Primary outcome
The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score
Time frame: 6 weeks
1 secondary outcome
Response rate, remission rate, and safety
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Derived from this study: PubMed 32242018Belzeaux 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.
- Derived from this study: PubMed 31087825Belzeaux 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.
Related trials for Major Depressive Disorder
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Not yet recruiting
Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
72 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lu AA24530 and Duloxetine in people with Major Depressive Disorder, run by H. Lundbeck A/S at 72 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in France, Czechia, Finland, India, Sweden and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00599911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.