NCT01614041

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of comparative high dose Tandospirone Citrate in the treatment of patients with generalized anxiety disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 10, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

6.7 years

First QC Date

November 11, 2011

Last Update Submit

January 5, 2020

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients whose Hamilton Anxiety Scale (HAMA) score change downwards ≥ 50% from baseline to 6 weeks treatment

    HAMA score changes downwards ≥ 50% indicate significant improvement; HAMA score changes downwards ≥ 75% indicate remission

    6 weeks

Secondary Outcomes (3)

  • HAMA score changes from baseline to 6 weeks treatment

    6 weeks

  • Percentage of patients whose HAMA score ≤ 7 after 6 weeks treatment

    6 weeks

  • HAMA factor score changes after treatment

    6 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patient randomized to control group is administrated with usual dose of tandospirone treatment, 30 mg/day

Drug: Usual dose treatment of Tandospirone

Study Group

EXPERIMENTAL

Comparative high dose of tandospirone treatment, 60 mg/day

Drug: Comparative high dose of tandospirone treatment

Interventions

Usual dose treatment of TandospironeDRUG

Usual dose treatment of Tandospirone, oral, 30 mg/day

Control Group
Comparative high dose of tandospirone treatmentDRUG

Comparative high dose of tandospirone treatment, oral, 60 mg/day

Study Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Male or female
  • Diagnosed with GAD according to DSM-IV
  • HAMA score≥17
  • Provide with written informed consent
  • Agree to be washed-out for two weeks if receiving SSRI, SNRI or NASA.

You may not qualify if:

  • Serious suicidal tendency
  • The score of the sixth item of HAMA ≥3
  • The score of HAMD ≥21
  • Pregnant or lactating women
  • History of allergic or hypersensitivity to tandospirone
  • Serious or unstable cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease
  • Secondary anxiety disorders
  • Drug or alcohol dependence within 1 year
  • Patients currently taking benzodiazepine drugs
  • Drivers and dangerous machine operators
  • Participated in other clinical studies in the last 30 days
  • Patients with clinically significant ECG or laboratory abnormalities
  • Patients with a history of epilepsy
  • Patients with abnormal TSH concentration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, 200065, China

Location

Related Publications (2)

  • Fu Y, Ji JL, Shi SX, Zhang HY, Lin GZ, Zhang YL, Li X, Wu WY. Early outcomes, associated factors and predictive values of clinical outcomes of tandospirone in generalized anxiety disorder: a post-hoc analysis of a randomized, controlled, multicenter clinical trial. Curr Med Res Opin. 2023 Apr;39(4):597-603. doi: 10.1080/03007995.2023.2175998. Epub 2023 Feb 26.

    PMID: 36842964DERIVED

  • Li Q, Zhang H, Lin G, Shi S, Zhang Y, Ji J, Yang L, Yao J, Wu W. Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial. Neuropsychiatr Dis Treat. 2022 Aug 8;18:1653-1664. doi: 10.2147/NDT.S366048. eCollection 2022.

    PMID: 35968511DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Wenyuan Wu, MD

    Shanghai Tongji Hospital, Tongji University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2011

First Posted

June 7, 2012

Study Start

January 10, 2012

Primary Completion

September 11, 2018

Study Completion

July 1, 2019

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

CN(1)