Trial reportPsychiatry and clinical neurosciences2025
A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release in Japanese patients with generalized anxiety disorder.
Trial report in Psychiatry and clinical neurosciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- An open-label, long-term extension, multicenter study to evaluate the safety and efficacy of venlafaxine extended release in Japanese outpatients with generalized anxiety disorder.PCN reports : psychiatry and clinical neurosciences · 2026Article
- Response to "Clinical relevance of venlafaxine ER for generalized anxiety disorder".Psychiatry and clinical neurosciences · 2026Article
- Effectiveness and Safety of Venlafaxine in Japanese Major Depressive Disorder Patients with or without Anxious Distress (EXPAND Study): A 12-Week Prospective Observational Study.Neuropsychiatric disease and treatment · 2026Article
- Disease Awareness, Care-Seeking Behavior, and Symptom Burden Among Japanese Patients with Generalized Anxiety Disorder: Results from a Web-Based Questionnaire of Clinical Trial Participants.Neuropsychiatric disease and treatment · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
aimThe current study investigated the superiority of anxiolytic effects of venlafaxine extended release (ER) compared with placebo and its safety and tolerability in Japanese adult outpatients with generalized anxiety disorder (GAD).
methodsIn this placebo-controlled, double-blind study, 357 eligible participants were randomized to receive venlafaxine ER (75-225 mg/day) or placebo for 8 weeks. The primary endpoint was change from baseline to week 8 in Hamilton Anxiety Rating Scale (HAM-A) total score. Secondary endpoints included changes from baseline to week 8 in scores of HAM-A psychic anxiety factors, HAM-A somatic anxiety factors, Clinical Global Impressions-Severity of Illness (CGI-S), Generalized Anxiety Disorder-7 (GAD-7), Zung Self-Rating Anxiety Scale (Z-SAS), Sheehan Disability Scale (SDS), and the absolute score of Clinical Global Impressions-Global Improvement (CGI-I).
resultsVenlafaxine ER showed statistically significant reduction in HAM-A total score at week 8 (difference versus placebo: P = 0.012). The results of all secondary endpoints were consistent with this finding and likewise demonstrated statistical significance in favor of venlafaxine ER in investigator- and patient-rated scales. Venlafaxine ER further showed statistically significant remission in total HAM-A score. These results showed that venlafaxine ER improved patients' functional disabilities along with symptoms more than placebo. Venlafaxine ER was well tolerated, and safety findings were generally consistent with the known safety profile of the drug.
conclusionVenlafaxine ER has a favorable benefit-risk profile in adult Japanese patients with GAD, indicating its potential to improve GAD symptoms as well as patients' function and exert superior anxiolytic effects over placebo without any new safety concern.
trial registrationJapan Registry of Clinical Trials Identifier jRCT2031220156.
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