Dose-finding Study With Lu AA24530 in Major Depressive Disorder

NCT00599911 | Completed Phase 2

• 2 other identifiers: 11918A2007-001071-11
• Study Type: interventional
• Target: 652
• Locations: 15 countries
• Sites: 65

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (1)

• Response rate, remission rate, and safety

  6 weeks

Study Arms (5)

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

Interventions

Lu AA24530 DRUG

per oral, once daily for 6 weeks

Lu AA24530: 10 mg; Lu AA24530: 20 mg; Lu AA24530: 5 mg

Duloxetine DRUG

per oral, once daily for 6 weeks

Duloxetine: 60 mg

Placebo DRUG

per oral, once daily for 6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (72)

AU002

Brisbane, 4000, Australia

Location

AU001

Brisbane, 4053, Australia

Location

AU003

Dandenc, 3175, Australia

Location

AU004

Epping, 3076, Australia

Location

AU006

Malvern, 3144, Australia

Location

AT001

Vienna, 1090, Austria

Location

AT002

Vienna, Austria

Location

AT003

Vienna, Austria

Location

BE003

Diest, 2930, Belgium

Location

BE002

Sint-Niklaas, 9100, Belgium

Location

CA006

Mississauga, L5M 4N4, Canada

Location

CA004

Oakville, L6J 7W5, Canada

Location

CA003

Penticton, V2A 4M4, Canada

Location

CA005

Toronto, M4S 1Y2, Canada

Location

CA001

Vancouver, V6Z 2L4, Canada

Location

CZ002

Brno, 60200, Czechia

Location

CZ005

Prague, 12000, Czechia

Location

CZ001

Prague, 15030, Czechia

Location

CZ004

Prague, 158 00, Czechia

Location

CZ003

Prague, 16000, Czechia

Location

CZ006

Sternberk, 78517, Czechia

Location

FI001

Helsinki, 00260, Finland

Location

FI003

Helsinki, 00530, Finland

Location

FI006

Jarvenpaa, Finland

Location

FI004

Seinäjoki, Finland

Location

FI005

Tampere, Finland

Location

FI002

Turku, 20100, Finland

Location

FR007

Angoulême, 16000, France

Location

FR002

Dole, 39100, France

Location

FR003

Montpellier, 34000, France

Location

FR001

Orvault, 44700, France

Location

FR008

Rouen, 76000, France

Location

FR004

Savigny-sur-Orge, 91600, France

Location

FR005

Wattigny, 59139, France

Location

IN001

Ahmedabab, India

Location

IN009

Ahmedabad, India

Location

IN007

Chennai, 3, India

Location

IN006

Hyderabaad, 500 034, India

Location

IN003

Mangalore, 574160, India

Location

IN002

Pune, 411004, India

Location

LT002

Kaunas, 50185, Lithuania

Location

LT003

Klaipėda, 91251, Lithuania

Location

LT001

Vilnius, Lithuania

Location

MY002

Kuala Lumpur, 55100, Malaysia

Location

MY003

Kuala Lumpur, 59100, Malaysia

Location

NO004

Fredrikstad, 1606, Norway

Location

NO001

Hamar, 2315, Norway

Location

NO003

Skien, 3725, Norway

Location

PH002

Las Piñas, 1701, Philippines

Location

PH003

Mandaluyong, Philippines

Location

PH001

Mandaue City, 6014, Philippines

Location

RU005

Arkhangelsk, 163061, Russia

Location

RU002

Nikol'skoye, 188357, Russia

Location

RU003

Saint Petersburg, 190005, Russia

Location

RU004

Saratov, 410028, Russia

Location

RU001

Tomsk, 634014, Russia

Location

RS004

Belgrade, 11000, Serbia

Location

RS002

Kragujevac, 34000, Serbia

Location

KR003

Gwangju, 501-757, South Korea

Location

KR002

Seoul, 120-752, South Korea

Location

KR001

Seoul, 138-746, South Korea

Location

SE006

Halmstad, 301 85, Sweden

Location

SE001

Linköping, 581 85, Sweden

Location

SE002

Lund, 223 61, Sweden

Location

SE003

Malmo, 21237, Sweden

Location

SE005

Stockholm, 112 34, Sweden

Location

SE004

Uppsala, 753 19, Sweden

Location

UA003

Dnipro, 49005, Ukraine

Location

UA005

Kharkiv, 61068, Ukraine

Location

UA002

Kyiv, 4080, Ukraine

Location

UA004

Lviv, 79021, Ukraine

Location

UA001

Odesa, 65006, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 32242018 DERIVED

• 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.

  PMID: 31087825 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder; Depression; Mood Disorders

Interventions

Tedatioxetine; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 24, 2008
• Study Start: October 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

PH (3); KR (3); MY (2); RU (5); FI (6); SE (6); CZ (6); IN (6); FR (7); UA (5); AU (3); BE (2); NO (3); LI (3); CA (5)