CoChat
Sign Up
Cited by 150Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesMental Health Treatment and Access

The DOI matches its Crossref record.

A Randomized, Double-Blind, Placebo-Controlled 8-Week Trial of the Efficacy and Tolerability of Multiple Doses of Lu AA21004 in Adults With Major Depressive Disorder

Henigsberg, Neven, Mahableshwarkar, Atul R., Jacobsen, Paula, Chen, Yinzhong, Thase, Michael E.·2012·The Journal of Clinical Psychiatry
DOI 10.4088/jcp.11m07470
Open this paper in CoChat — free account

Abstract

Article AbstractObjective: Lu AA21004 is an investigational multimodal antidepressant. This randomized controlled trial evaluated the efficacy and tolerability of multiple doses of Lu AA21004 versus placebo in adults with major depressive disorder (MDD). Method: Adults diagnosed with MDD (based on DSM-IV-TR criteria) with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 26 were randomly assigned (1:1:1:1) to receive Lu AA21004 1 mg, 5 mg, or 10 mg or placebo for 8 weeks (between August 2008 and August 2009). The primary endpoint was reduction in 24-Item Hamilton Depression Rating Scale (HDRS-24) total score after 8 weeks of treatment compared with placebo for Lu AA21004 10 mg. Additional outcomes included response and remission rates, Sheehan Disability Scale (SDS), Clinical Global Impressions-Global Improvement scale (CGI-I), MADRS total score, and HDRS-24 total score in subjects with baseline Hamilton Anxiety Rating Scale (HARS) score ≥ 20. Adverse events were assessed throughout the study. Results: A total of 560 subjects (mean age = 46.4 years) were randomized. There was a statistically significant reduction from baseline in HDRS-24 total score at week 8 for Lu AA21004 10 mg vs placebo (P < .001). There were improvements (nominal P values < .05 with no adjustment for multiplicity) in HDRS-24 total score, response and remission rates, CGI-I score, MADRS total score, and HDRS-24 total score in subjects with baseline HARS score ≥ 20 at week 8 for all Lu AA21004 treatment groups vs placebo. No significant differences were seen in SDS scores between any dose of Lu AA21004 and placebo. The most common adverse events were nausea, headache, and dizziness. Conclusions: After 8 weeks of treatment with Lu AA21004 10 mg, there was a significant reduction in HDRS-24 total score compared with placebo in adults with MDD. Lu AA21004 was well tolerated in this study. Trial Registration: ClinicalTrials.gov identifier: NCT00735709 J Clin Psychiatry 2012;73(7):953-959 © Copyright 2012 Physicians Postgraduate Press, Inc. Submitted: October 14, 2011; accepted March 7, 2012 (doi:10.4088/JCP.11m07470). Corresponding author: Neven Henigsberg, MD, Poliklinika Neuron, Croatian Institute for Brain Research, Medical School, University of Zagreb, Salata 12, Zagreb, 10000, Croatia (neven.henigsberg@zg.t-com.hr).†‹

Overview

Integrity signals

Registry

Crossref · 10.4088/jcp.11m07470

Cites

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Citations

Cites

Still being checked.

Cited by

Sorted by citations

Related

See all

Metadata

Authors
Henigsberg, N., Mahableshwarkar, A. R., Jacobsen, P., Chen, Y., & Thase, M. E.
Affiliations
University of Zagreb (HR)
Corresponding author
Henigsberg, Neven
ORCID
Venue
The Journal of Clinical Psychiatry
Publisher
Physicians Postgraduate Press, Inc
Published
2012-07-15
Volume
73
Issue
07
Pages
953-959
ISSN
0160-6689 (ISSN-L)
DOI
10.4088/jcp.11m07470
OpenAlex
W2059274457
Cited by
150
References
0
Citations by year
2026: 1 · 2025: 5 · 2024: 6 · 2023: 4 · 2022: 7 · 2021: 10 · 2020: 5 · 2019: 7 · 2018: 13 · 2017: 15 · 2016: 14 · 2015: 28 · 2014: 23 · 2013: 10 · 2012: 2
FWCI
14.83
Type
journal article
Language
en
Open access
closed
Locations
  • The Journal of Clinical Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Health Sciences › Medicine › Psychiatry and Mental health › Mental Health Treatment and Access
Keywords
vortioxetine, major depressive disorder, multimodal antidepressant, antidepressant efficacy, antidepressant tolerability, dose comparison, anxiety symptoms, adverse events, nausea, headache, dizziness, Hamilton Depression Rating Scale, Sheehan Disability Scale, Montgomery-Asberg Depression Rating Scale, placebo-controlled
MeSH terms
Vortioxetine, Adult, Affect, Major Depressive Disorder, Dose-Response Relationship, Drug, Double-Blind Method, Humans, Personality Inventory, Piperazines, Psychometrics, Sulfides, Anti-Anxiety Agents

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review