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Completed

NCT Number: NCT01614041

Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Tongji Hospital

Shanghai, 200065, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 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.

Exclusion criteria

  • 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

Treatment and study plan

Usual dose treatment of Tandospirone

Drug

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

Comparative high dose of tandospirone treatment

Drug

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

Primary outcomes

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

    Time frame: 6 weeks

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

Secondary outcomes

  1. HAMA score changes from baseline to 6 weeks treatment

    Time frame: 6 weeks

    Scores 14-21 indicate mild anxiety; scores 21-29 indicate moderate anxiety; scores over 29 indicate severe anxiety

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

    Time frame: 6 weeks

    Scores ≤ 7 indicate non-anxious

  3. HAMA factor score changes after treatment

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Marubeni Pharmaceuticals (Suzhou) Co., Ltd.

Industry

Registry information

Official study title

Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder: a Multi-center, Randomized, Usual Dose-controlled Trial

Acronym: TACGAD

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Jun 7, 2012
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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