Generalized Anxiety DisorderPhase 4TACGADNCT01614041
Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder
A Phase 4 study testing Usual dose treatment of Tandospirone and Comparative high dose of tandospirone treatment in people with Generalized Anxiety Disorder, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Usual dose treatment of Tandospirone and Comparative high dose of tandospirone treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2012to Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder: a Multi-center, Randomized, Usual Dose-controlled Trial
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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Usual dose treatment of Tandospirone, Comparative high dose of tandospirone treatment
- Keywords
- Generalized Anxiety Disorder
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual dose treatment of TandospironeDrug
Usual dose treatment of Tandospirone, oral, 30 mg/day
Comparative high dose of tandospirone treatmentDrug
Comparative high dose of tandospirone treatment, oral, 60 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patient randomized to control group is administrated with usual dose of tandospirone treatment, 30 mg/day Receives: Drug: Usual dose treatment of Tandospirone |
| Study Group | Experimental | Comparative high dose of tandospirone treatment, 60 mg/day Receives: Drug: Comparative high dose of tandospirone treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (3)
HAMA score changes from baseline to 6 weeks treatment
Scores 14-21 indicate mild anxiety; scores 21-29 indicate moderate anxiety; scores over 29 indicate severe anxiety
Measured: 6 weeks
Percentage of patients whose HAMA score ≤ 7 after 6 weeks treatment
Scores ≤ 7 indicate non-anxious
Measured: 6 weeks
HAMA factor score changes after treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study start10 Jan 2012
- Primary completion11 Sep 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenyuan Wu, MD, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614041
- Sponsor's protocol ID
- DSPC-SED-1101
- Acronym
- TACGAD
- Status last verified
- Jan 2020
- First submitted
- 11 Nov 2011
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36842964Li 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.
PubMed 35968511
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder: a Multi-center, Randomized, Usual Dose-controlled Trial
- ClinicalTrials.gov ID
- NCT01614041
- Acronym / sponsor ID
- TACGAD / DSPC-SED-1101
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2012 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Usual dose treatment of TandospironePatient randomized to control group is administrated with usual dose of tandospirone treatment, 30 mg/day |
| Study Group | Experimental | Drug: Comparative high dose of tandospirone treatmentComparative high dose of tandospirone treatment, 60 mg/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 years old
- Male or female
- Diagnosed with GAD according to DSM-IV
- HAMA score≥17
- Provide with written informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual dose treatment of TandospironeUsual dose treatment of Tandospirone, oral, 30 mg/day | Drug | Control Group |
| Comparative high dose of tandospirone treatmentComparative high dose of tandospirone treatment, oral, 60 mg/day | Drug | Study Group |
Primary outcome
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
3 secondary outcomes
HAMA score changes from baseline to 6 weeks treatment
Time frame: 6 weeks
Percentage of patients whose HAMA score ≤ 7 after 6 weeks treatment
Time frame: 6 weeks
HAMA factor score changes after treatment
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Derived from this study: PubMed 36842964Fu 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.
- Derived from this study: PubMed 35968511Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenyuan Wu, MD principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Usual dose treatment of Tandospirone and Comparative high dose of tandospirone treatment in people with Generalized Anxiety Disorder, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients whose Hamilton Anxiety Scale (HAMA) score change downwards ≥ 50% from baseline to 6 weeks treatment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01614041, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.