A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.

Luye Pharma Group

Status and phase: Enrolling; Phase 3

Conditions: Generalized Anxiety Disorder

Treatments: Drug: placebo; Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg; Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05970510

LY03005/CT-CHN-307

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 555 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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555 participants in 3 patient groups

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group

Experimental group

Description:

orally once a day

Treatment:

Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group

Experimental group

Description:

orally once a day

Treatment:

Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg

Placebo

Sham Comparator group

Description:

orally once a day

Treatment:

Drug: placebo