Exploratory Study of the Effects of Vortioxetine (Lu AA21004) on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in Controls

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Placebo; Drug: Vortioxetine (Lu AA21004)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01607125

14137A

2011-001839-23 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine if Vortioxetine 20 mg/day will lead to changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with executive functioning and memory during cognitive task performances compared to placebo in subjects remitted from depression and in controls, and to explore if Vortioxetine will lead to improved cognitive performance in the absence of depression.

Enrollment: 96 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All subjects must have:

• a Hamilton Depression Rating Scale (HAM-D17) total score ≤ 7

Subjects remitted from depression must:

• be in remission from recurrent depression having suffered from at least two previous Major Depressive Episodes (MDEs)
• have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE
• report present subjective cognitive dysfunction
• not have been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to screening visit

Control group subjects must:

• have no history of MDEs
• have no history of MDEs in a biological parent or other first degree relative as reported by the subject
• not report present subjective cognitive dysfunction
• never have been treated with antidepressants or psychotherapy

Exclusion criteria

• The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups, including a placebo group

Vortioxetine

Experimental group

Treatment:

Drug: Vortioxetine (Lu AA21004)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo