Study of Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

Takeda

Status and phase: Completed; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: Vortioxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00731120

LuAA21004_309

U1111-1114-2380 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Full description

Participants in this study will be randomly assigned to receive either 2.5 mg or 10 mg of vortioxetine or a placebo once daily for an eight week treatment period.

Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Total commitment time is up to 12 weeks.

Enrollment: 457 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria (classification code 300.02).
• Has a Hamilton Anxiety Scale total score ≥ 20.
• Has a Hamilton Anxiety Scale score ≥ 2 on both item 1 (anxious mood) and item 2 (tension).
• Has a Montgomery-Åsberg Depression Rating Scale total score ≤16.

Exclusion criteria

• Has 1 or more of the following:

  • Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR (as assessed by 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.
  • Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR and participant must have a negative urine drug screen prior to Baseline.
  • Presence or history of a clinically significant neurological disorder (including epilepsy).
  • Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc.).
  • Any Axis II disorder that might compromise the study.

• Is taking excluded medications.

• 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.

• Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal.

• Has a serum creatinine of > 1.5 × the upper limit of normal.

• Has a previous history of cancer that had been in remission for less than 5 years.

• Has thyroid stimulating hormone value outside the normal range.

• Has an abnormal electrocardiogram.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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457 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Vortioxetine 2.5 mg

Experimental group

Description:

Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks.

Treatment:

Drug: Vortioxetine

Vortioxetine 10 mg

Experimental group

Description:

Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.

Treatment:

Drug: Vortioxetine