a study to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in generalized anxiety disorder.

Conditions: Generalized Anxiety Disorder

Summary: 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.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18 to 65 years subjects; 2. meet the diagnostic and statistical manual of manual disorders, fifth edition(dsm-5) criteria for generalized anxiety disorder; 3. have a hamilton anxiety(hama) rating scale total score ≥21 points at screening and baseline; 4. have a hamilton anxiety(hama) rating scale score ≥2 points on both item 1(anxious mood) and item 2(tension) at screening and baseline; 5. have a clinical global impression -severity illness (cgi-s) score≥4 points at screening and baseline. exclusion criteria: 1. meet the diagnostic criteria for other psychotic disorders(defined by dsm-5, except for gad), including major depression disorder within 6 months prior to screening , presence or history of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, post-traumatic stress disorder, anorexia nervosa or bulimia and personality disorder; 2. meet the diagnostic criteria for substance or alcohol abuse (defined by dsm-5, except for nicotine or caffeine) within 6 months prior to screening; 3. have anxious symtoms secondary to other physical illnesses or mental illnesses and anxious induced by psychoactive substance; 4. withdrawal psychotropic drugs within 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors, at least 1 month for fluoxetine, and at least 2 weeks for benzodiazepines or barbiturates) prior to randomization; 5. have received psychosurgery or physical therapy for psychiatric illness (such as transcranial magnetic stimulation) within 3 months prior to screening; 6. have received systematic psychotherapy or other non-drug therapies for psychiatric disorders (such as acupuncture or light therapy) within 6 weeks prior to screening; 7. concomitant with serious and unstable illness, including cardiovascular, hepatic, renal, hematological, endocrine illness, malignant tumors and other physical illness; 8. have a history of seizures (except for seizures caused by febrile convulsions in childhood); 9. have a history of gastrointestinal disease or surgery known to interfere with investigation product absorption or excretion; 10. known or suspected allergic or severe reaction to investigation product or inactive ingredients; or allergic to venlafaxine or desvenlafaxine; or allergic constitution (defined as allergic to two or more drugs or food) and unfit to participate judged by investigator;

Keywords: toludesvenlafaxine hydrochloride sustained-release tablet generalized anxiety disorder efficacy safety