The study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets compared to placebo in adults participants with generalized anxiety disorder over a period of 8 weeks.
The study consists of two periods: screening period (2 weeks) and double-blind treatment period (8 weeks). After the screening period, generalized anxiety disorder patients who satisfies the inclusion criteria are randomly assigned in the 1:1:1 ratio to receive either placebo or Toludesvenlafaxine Hydrochloride Sustained-release Tablets at two dose levels (80 ,160 mg/day) for 8 weeks. Participants are evaluated at screening, baseline visits and double-blind period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
555
Peking University Sixth Hospital
Beijing, China
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint
The HAMA Scale consist of 14 items that include psychic, somatic, and behavioral symptoms associated with anxiety. Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 56, with high scores indicating greater illness severity.
Time frame: from baseline to week 8
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale psychic factor score (Items 1~6 and Item 14) at endpoint
The psychic factor score is the sum of items 1-6 and items 14(including items such as anxious mood, tension, fear, insomnia, and behavioral symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.
Time frame: from baseline to week 8
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) at endpoint
The somatic factor score is the sum of items 7-13(including items such as cardiovascular, respiratory, and gastrointestinal symptoms).Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 28, with high scores indicating greater illness severity.
Time frame: from baseline to week 8
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 1(Anxious mood)Score at endpoint
The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.
Time frame: from baseline to week 8
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 2(Tension)Score at endpoint
The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.
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Time frame: from baseline to week 8
Percentage of participants with response at endpoint
Response was defined as a≥50% reduction from baseline to endpoint in the HAMA total score.
Time frame: from baseline to week 8
Percentage of participants with remission at endpoint
Remission was defined as a HAMA total score ≤7 points at endpoint
Time frame: from baseline to week 8
Clinical Global Impression Scale - improvement (CGI-I) score at endpoint
The CGI-I scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time frame: from baseline to week 8
Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint
The CGI-S scale is a 7-point scale to rate the severity of the patient's illness. Patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Time frame: from baseline to week 8
Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint
The SDS scale consists of 3 items evaluating impairment in work/school, social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).
Time frame: from baseline to week 8
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint
The scale consists of 3 items evaluating impairment in work/school, social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).
Time frame: from baseline to week 8
Incidence and severity of adverse effects (AEs)
Time frame: from baseline to week 8
Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score at endpoint
The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Time frame: from baseline to week 8