Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.

NCT ID: NCT00744627

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-07-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily (QD), in adults with Generalized Anxiety Disorders.

Detailed Description

The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine.

The study enrolled 301 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

• Vortioxetine 5 mg
• Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-center trial was conducted in Europe. The overall time to participate in this study was up to 13 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Vortioxetine placebo-matching capsules

Vortioxetine 5 mg

Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

Encapsulated vortioxetine immediate-release tablets.

Interventions

Vortioxetine

Encapsulated vortioxetine immediate-release tablets.

Intervention Type: DRUG

Placebo

Vortioxetine placebo-matching capsules

Intervention Type: DRUG

Other Intervention Names

Lu AA21004; Brintellix®

Eligibility Criteria

Inclusion Criteria

• Suffers from a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
• Has a Hamilton Anxiety Scale total score ≥20 at Screening and Baseline.
• Has a Hamilton Anxiety Scale score ≥2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline.
• Has a Montgomery-Åsberg Depression Rating Scale total score ≤16 at Screening and Baseline.
• Male and females of childbearing potential who are sexually active agree to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.

Exclusion Criteria

• Has received any investigational compound <30 days before Screening or 5 half-lives prior to Screening.
• Has received Lu AA21004 in a previous clinical study or as a therapeutic agent.
• Has 1 or more of the following:

• Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR.
• 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.
• Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
• Presence or history of a clinically significant neurological disorder (including epilepsy).
• Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington disease, etc).
• Any Axis II disorder that might compromise the study.
• Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study including:

• Nonsteroidal anti-inflammatory drugs
• Rifampin
• Macrolide antibiotics
• Hormones
• Hypoglycemic agents and Insulin
• Systemic steroids
• Antineoplastics
• Antiobesity agents
• Antidiarrheal agents (episodic use allowed)
• Antifungal agents (episodic topical use allowed)
• Antihistamines (episodic use of loratadine, desloratadine, cetirizine allowed)
• Cough/cold agents (episodic use allowed but preparations containing pseudoephedrine and narcotics are NOT allowed)
• Diuretics (episodic use allowed)
• Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
• Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
• Has received electroconvulsive therapy within 6 months prior to Screening.
• Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
• Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.
• Has an alanine aminotransferase, aspartate aminotransferase or bilirubin level >1.5 times the upper limits of normal.
• Has a serum creatinine of >1.5 times the upper limits of normal.
• Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those participants with basal cell or stage I squamous cell carcinoma of the skin.
• Has clinically significant abnormal vital signs as determined by the investigator.
• Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at Screening, that are considered by the investigator to be clinically significant.
• Has thyroid stimulating hormone value outside the normal range at Screening and is deemed clinically significant by the investigator.
• Has an abnormal electrocardiogram as determined by the central reader and confirmed as clinically significant by the investigator.
• Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
• Has previously participated in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director, Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Tallinn, , Estonia

Viljandi, , Estonia

Bad Saarow, , Germany

Berlin, , Germany

Bochum, , Germany

Hüttenberg, , Germany

Rodgau, , Germany

Schwerin, , Germany

Wiesbaden, , Germany

Liepāja, , Latvia

Riga, , Latvia

Sigulda, , Latvia

Kaunas, , Lithuania

Palanga, , Lithuania

Vilnius, , Lithuania

Bialystok, , Poland

Gdynia, , Poland

Gorlice, , Poland

Leszno, , Poland

Skórzewo, , Poland

Torun, , Poland

Tuszyn, , Poland

Bucharest, , Romania

Oradea, , Romania

Kazan', , Russia

Lipetsk, , Russia

Moscow, , Russia

Rostov-on-Don, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Smolensk, , Russia

Stavropol, , Russia

Yekaterinburg, , Russia

Dnipro, , Ukraine

Kharkiv, , Ukraine

Liev, , Ukraine

Luhansk, , Ukraine

Simferopol, , Ukraine

Countries

Estonia; Germany; Latvia; Lithuania; Poland; Romania; Russia; Ukraine

References

Bidzan L, Mahableshwarkar AR, Jacobsen P, Yan M, Sheehan DV. Vortioxetine (Lu AA21004) in generalized anxiety disorder: results of an 8-week, multinational, randomized, double-blind, placebo-controlled clinical trial. Eur Neuropsychopharmacol. 2012 Dec;22(12):847-57. doi: 10.1016/j.euroneuro.2012.07.012. Epub 2012 Aug 14.

Reference Type: RESULT

PMID: 22898365 (View on PubMed)

Christensen MC, Loft H, Florea I, McIntyre RS. Efficacy of vortioxetine in working patients with generalized anxiety disorder. CNS Spectr. 2019 Apr;24(2):249-257. doi: 10.1017/S1092852917000761. Epub 2017 Oct 30.

Reference Type: DERIVED

PMID: 29081307 (View on PubMed)

Other Identifiers

2008-001766-90

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1112-3487

Identifier Type: OTHER

Identifier Source: secondary_id

LuAA21004_311

Identifier Type: -

Identifier Source: org_study_id