Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

NCT01140906 | Completed Phase 3 Results

• 2 other identifiers: 13267A2009-017523-26
• Study Type: interventional
• Target: 607
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate the efficacy, tolerability and the safety of two fixed doses of vortioxetine in the treatment of major depressive disorder.

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; Placebo-controlled; Active reference; Multicenter study; Randomised study; Acute treatment

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in MADRS Total Score After 8 Weeks of Treatment.

  The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.

  Baseline and Week 8

Secondary Outcomes (7)

• Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)

  Week 8

• Change in Clinical Status Using CGI-I Score at Week 8

  Week 8

• Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20

  Baseline and Week 8

• Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)

  Week 8

• Change From Baseline in SDS Total Score After 8 Weeks of Treatment

  Baseline and Week 8

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Vortioxetine: 15 mg

EXPERIMENTAL

Drug: Vortioxetine (Lu AA21004)

Vortioxetine: 20 mg

EXPERIMENTAL

Drug: Vortioxetine (Lu AA21004)

Duloxetine: 60 mg

OTHER

Active Reference

Drug: Duloxetine

Interventions

Placebo DRUG

capsules, daily, orally

Placebo

Vortioxetine (Lu AA21004) DRUG

encapsulated tablets, daily, orally

Also known as: Brintellix

Vortioxetine: 15 mg; Vortioxetine: 20 mg

Duloxetine DRUG

encapsulated capsules, daily, orally

Also known as: Cymbalta®

Duloxetine: 60 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x)
• The patient has a MADRS total score \>=26
• The patient has a CGI-S score \>=4
• The patient has had the current episode of MDE for \>3 months

You may not qualify if:

• Any current anxiety psychiatric disorder as defined in the DSM-IV TR
• Current diagnosis or 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
• Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR
• Use of any psychoactive medication 2 weeks prior to screening and during the study
• The patient is at significant risk of suicide or has a score \>=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Related Publications (6)

• Adair M, Christensen MC, Florea I, Loft H, Fagiolini A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26.

  PMID: 36708956 DERIVED

• 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

• Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13.

  PMID: 31818787 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

• McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.

  PMID: 27780334 DERIVED

• Boulenger JP, Loft H, Olsen CK. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder. Int Clin Psychopharmacol. 2014 May;29(3):138-49. doi: 10.1097/YIC.0000000000000018.

  PMID: 24257717 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: H. Lundbeck A/S
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

+45 3630 1311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 10, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2011
• Last Updated: February 11, 2014
• Results First Posted: February 11, 2014

Record last verified: 2013-12