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Phase Ⅲ Clinical Trial of Buagafuran Capsules in the Treatment of GAD

ConditionGeneralized Anxiety Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Union Pharmaceutical Factory Ltd

About this trial

A placebo-controlled superiority design was used to evaluate the efficacy of 60-120 mg/ day of Buagafuran capsules in the treatment of GAD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Outpatients aged 18-65 years old, of both sexes;

Met the diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for generalized anxiety disorder (GAD) and confirmed by the Brief International Neuropsychiatric Interview (M.I.N.I.);

The patient requires psychiatric medication;

Hamilton Anxiety Scale (HAMA) score ≥20, Hamilton Depression Scale (HAMD-17) score ≤2, Clinical Global Impression Scale (CGI-S) score ≥4 at screening and baseline Points;

Disqualifiers

Patients with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3;

Patients with HAMD-17 > 17;

Those who met the DSM-5 diagnostic criteria for other mental disorders except GAD;

Patients with previous history of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorder, factitious disorder and somatoform disorder; There were severe personality disorders, especially antisocial, borderline, or histrionic personality disorder, which were judged by the investigator to affect the patient's adherence to the study protocol;

Trial design

Design model

Factorial

Treatments tested in this trial

  • Buagafuran capsules, 15mg/ capsule

    Drug

    Participants took 60-120 mg Buagafuran capsules daily. The initial dose was 60mg/ day, 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;

  • Buspirone tablets, 5mg/ tablet

    Drug

    Participants took 10-20mg Buspirone tablets daily. The initial dose was 10mg/ day, 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.

  • Buagafuran capsules mimic, 0mg/ capsule

    Drug

    Participants took Buagafuran capsules mimic daily. 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;

  • Buspirone tablets mimic, 0mg/ tablet

    Drug

    Participants took Buspirone tablets mimic daily. 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.

Treatment groups

410 Participants
are divided into 3 treatment groups
Group A: Experimental groupExperimental treatment 2 interventions
Group B: Positive-control groupActive comparator 2 interventions
Group C: Placebo-control groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in Hamilton anxiety scale score after treatment

The Hamilton Anxiety (HAMA) Scale total score reflects the severity of the patients anxiety symptoms. The primary efficacy end point was the change from baseline to week 8 in HAMA total score to determine the superiority of buagafuran capsules over placebo. The larger the difference between buagafuran capsules over placebo, the better the curative effect.

Time frame
the end of week 8

Secondary outcomes

1

Change in each factor score and item score of Hamilton anxiety scale

One of the secondary efficacy end point was the change from baseline to week 4 and 8 in each factor score and item score of Hamilton anxiety scale to determine the superiority of buagafuran capsules over placebo. The larger the difference between buagafuran capsules over placebo, the better the curative effect.

Time frame
the end of week 4 and 8
2

Clinical global impression of improvement score

Subjective improvement of buagafuran capsules will be assessed using Clinical Global Impression of Improvement (CGI-I) score at week 4 and 8. The larger the difference between buagafuran capsules over placebo, the better the curative effect.

Time frame
the end of week 4 and 8
3

Clinical global impression of severity score

Subjective severity of buagafuran capsules will be assessed by the change from baseline to week 4 and 8 with Clinical global impression of severity (CGI-S) score, to determine the superiority of buagafuran capsules over placebo. The larger the difference between buagafuran capsules over placebo, the better the curative effect.

Time frame
the end of week 4 and 8
4

Complete remission rate

Complete remission rate was the proportion of subjects with HAMA total scale score ≤7 at the end of week 8. The larger the difference between buagafuran capsules over placebo, the better the curative effect.

Time frame
the end of week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Union Pharmaceutical Factory Ltd

Lead sponsor

R&G Pharma Studies Co.,Ltd.

Collaborator

Source ClinicalTrials.gov
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