Bipolar DisorderPhase 4AGTs-BDNCT01938859

Algorithm Guided Treatment Strategies for Bipolar Depression

A Phase 4 study testing Lithium, Quetiapine and Shuganjieyu capsule in people with Bipolar Disorder, run by Shanghai Mental Health Center at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The purpose of the AGTs-BD study is to compare the treatment outcome and safety profiles between different mood stabilizers combination treatments in the patients with bipolar disorders, currently suffered from depression episode. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar Disorder
What is being tested?: Lithium, Quetiapine and Shuganjieyu capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 1 siteChina
Study dates: Jun 2012to Dec 2018
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

Age from 18 to 65 years old;
Han Chinese;
Outpatient and inpatient patients;
Patients met DSM-IV criteria of bipolar I or II disorder, currently depressed, ascertained with the Mini International Neuropsychiatric Interview (MINI)
HAM-D total score≥17, HAM-D item 1 (depressed mood) score≥2, and YMRS total score≤10 at baseline;
Written informed consent was given;
Junior high school education and above, with enough audio-visual ability to accomplish the visits;
Normally resident in one country and had a residential address, able to follow-up.

Who cannot join

Bipolar disorder rapid cycling or mixed episode;
Experienced DSM-IV-TR axis I disorders in the 6 months prior to randomization;
Severe personality disorder, metal retardation, anorexia/bulimia nervosa;
Actively suicide ascertained by research psychiatrist or HAM-D item 3 score≥3(suicidality);
Known history of intolerance or hypersensitivity to any of the medications involved in the study, including lithium, quetiapine and SGJY capsule;
Female patients who were pregnant, planning to be pregnant or breast feeding;
Severe medical or neurological problems.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Read the detailed description

The AGTs-BD study is a randomized, open-label, rater-blind, multicenter study, which including an 8-week acute treatment (Phase I), followed by a 24-week recurrence prevention treatment (Phase II), and a 24-week relapse prevention treatment (Phase III). Patients initially enter an up to 4 weeks screening phase to confirm the randomization to whom met DSM-IV criteria of bipolar I or II disorder, currently depressed with Hamilton Depression Rating Scale-17 items (HAM-D) total score ≥17. The protocol was approved by the each sites' appropriate institutional review boards and ethics committees. After screening, patients were randomly allocated to one of three groups: (1) lithium monotherapy; (2) lithium plus quetiapine; (3) lithium plus a Traditional Chinese Medicine (TCM) named as Shuganjieyu capsule (SGJY, St. John's wort and acanthopanax senticosus combination). After phase I, patients who met stable remission, defined as HAM-D total score ≤7 and Young Mania Rating Scale (YMRS) total score ≤10 in two consecutive visit at least 4 weeks, were qualified into phase II and III. Patients remained on the allocated treatment for up to 48 weeks or until treatment failure. The difference between phase II and phase III was that treatment dose could be decreased (within the study ranges) if side-effects became troublesome in phase III, but not for phase II. All patients will be provided with free care (3 visits) by the investigators, for a period of up to 3 months after the end of the study, in order to help them make the transition into routine clinical care.

Conditions: Bipolar Disorder
Being tested: Lithium, Quetiapine, Shuganjieyu capsule
Keywords: bipolar disorder, lithium, quetiapine, Medicine, Chinese Traditional, efficacy, safety, Recurrence
Medical subject headings: Bipolar Disorder, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LithiumDrug
Lithium plasma concentration was between 0.6-1.2 mmol/L, dose should be fixed at the end of week 4, and the maximum dosage was judged by the investigator based on the patients' tolerability.
QuetiapineDrug
Quetiapine adjunctively to lithium therapy, target 400 mg/d with a minimum dose of 200 mg/d. Dose should be fixed at the end of week 4, and the maximum dosage was judged by the investigator based on the patients' tolerability.
Shuganjieyu capsuleDrug
Also called SGJY, St.John's wort and acanthopanax senticosus combination
Shuganjieyu capsule adjunctively to lithium therapy, target dose 1440 mg/d.

Study groups in NCT01938859
Study group	Role	What they receive
Lithium combined with SGAs	Experimental	SGAs (Second Generation Antipsychotics), quetiapine adjunctive to lithium therapy Receives: Drug: Lithium; Drug: Quetiapine
lithium combined with TCM	Experimental	TCM (Traditional Chinese Medicine), Shuganjieyu capsule adjunctive to lithium therapy. Receives: Drug: Lithium; Drug: Shuganjieyu capsule
Lithium monotherpy	Active comparator	Lithium monotherapy Receives: Drug: Lithium

What is being measured

The primary outcome is the main question the study is designed to answer.

The change of HAM-D total score only for the phase I
Measured: baseline and 8 weeks
Time to new intervention for an emerging mood episode
Time to new intervention for an emerging mood episode is only for Phase II and Phase III, including drug treatment (commencement of a new drug, increase in dose of concurrent drug, restarting of a discontinued drug, or increasing the investigational drug dose in response to an emergent mood episode) or admission to hospital.
Measured: up to 48 weeks

Secondary outcomes (7)

HAM-D total score ≤7
Remission rate
Measured: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in HAM-D total score ≥50%
Response rate
Measured: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in 16-item Quick Inventory of Depressive Symptomatology-Patient Self-Report (QIDS16-SR)
Measured: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in Clinical Global Impression scale of Bipolar Disorder-Severity (CGI-BP-S)
Measured: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in Sheehan Disability Scale (SDS)
Social function
Measured: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in 6-item Quality of Life scale (QOL-6)
Social function
Measured: 8 weeks for phase I, up to 48 weeks for phase II and III
Young Mania Rating Scale (YMRS) total score ≤10
Using YMRS total score to monitor the switching from depression to hypomania and mania
Measured: 8 weeks for phase I, up to 48 weeks for phase II and III

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Dec 2018

First posted10 Sep 2013 (estimated)
Study startJun 2012
Primary completionDec 2017 (estimated)
Study completionDec 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bipolar 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 360 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01938859
Sponsor's protocol ID: 2012BAI01B04-BD
Other IDs: 2012BAI01B04
Acronym: AGTs-BD
Status last verified: Oct 2017
First submitted: 5 Sep 2013
Last updated: 5 Oct 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bipolar Disorder Type I With Mania
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
RecruitingPhase 2
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
Bipolar I Disorder
Enrolling by invitation
Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
Schizophrenia Disorder, Schizoaffective Disorder
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Bipolar-I Disorder With Mania or Mania With Mixed Features

All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Algorithm Guided Treatment Strategies for Bipolar Depression
ClinicalTrials.gov ID: NCT01938859
Acronym / sponsor ID: AGTs-BD / 2012BAI01B04-BD
Conditions: Bipolar Disorder
Keywords: bipolar disorder, lithium, quetiapine, Medicine, Chinese Traditional, efficacy, safety, Recurrence
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 360 participants (estimated)
Lead sponsor: Shanghai Mental Health CenterUniversity, hospital or other
Study start: Jun 2012 (actual)
Primary completion: Dec 2017 (estimated)
Study completion: Dec 2018 (estimated)
First posted: 10 Sep 2013 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Lithium combined with SGAs	Experimental	Drug: Lithium, Drug: QuetiapineSGAs (Second Generation Antipsychotics), quetiapine adjunctive to lithium therapy
lithium combined with TCM	Experimental	Drug: Lithium, Drug: Shuganjieyu capsuleTCM (Traditional Chinese Medicine), Shuganjieyu capsule adjunctive to lithium therapy.
Lithium monotherpy	Active comparator	Drug: LithiumLithium monotherapy

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age from 18 to 65 years old;
Han Chinese;
Outpatient and inpatient patients;
Patients met DSM-IV criteria of bipolar I or II disorder, currently depressed, ascertained with the Mini International Neuropsychiatric Interview (MINI)
HAM-D total score≥17, HAM-D item 1 (depressed mood) score≥2, and YMRS total score≤10 at baseline;

Key exclusion criteria (7 listed)

Bipolar disorder rapid cycling or mixed episode;
Experienced DSM-IV-TR axis I disorders in the 6 months prior to randomization;
Severe personality disorder, metal retardation, anorexia/bulimia nervosa;
Actively suicide ascertained by research psychiatrist or HAM-D item 3 score≥3(suicidality);
Known history of intolerance or hypersensitivity to any of the medications involved in the study, including lithium, quetiapine and SGJY capsule;

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
LithiumLithium plasma concentration was between 0.6-1.2 mmol/L, dose should be fixed at the end of week 4, and the maximum dosage was judged by the investigator based on the patients' tolerability.	Drug	Lithium combined with SGAs, Lithium monotherpy, lithium combined with TCM
QuetiapineQuetiapine adjunctively to lithium therapy, target 400 mg/d with a minimum dose of 200 mg/d. Dose should be fixed at the end of week 4, and the maximum dosage was judged by the investigator based on the patients' tolerability.	Drug	Lithium combined with SGAs
Shuganjieyu capsuleAlso: SGJY, St.John's wort and acanthopanax senticosus combinationShuganjieyu capsule adjunctively to lithium therapy, target dose 1440 mg/d.	Drug	lithium combined with TCM

Primary outcome

The change of HAM-D total score only for the phase I
Time frame: baseline and 8 weeks
Time to new intervention for an emerging mood episode
Time frame: up to 48 weeks
Time to new intervention for an emerging mood episode is only for Phase II and Phase III, including drug treatment (commencement of a new drug, increase in dose of concurrent drug, restarting of a discontinued drug, or increasing the investigational drug dose in response to an emergent mood episode) or admission to hospital.

7 secondary outcomes

HAM-D total score ≤7
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in HAM-D total score ≥50%
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in 16-item Quick Inventory of Depressive Symptomatology-Patient Self-Report (QIDS16-SR)
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in Clinical Global Impression scale of Bipolar Disorder-Severity (CGI-BP-S)
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in Sheehan Disability Scale (SDS)
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in 6-item Quality of Life scale (QOL-6)
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Young Mania Rating Scale (YMRS) total score ≤10
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.

Related trials for Bipolar Disorder

RecruitingPhase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bipolar Disorder Type I With Mania
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
RecruitingPhase 2
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
Bipolar I Disorder
Enrolling by invitation
Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
Schizophrenia Disorder, Schizoaffective Disorder
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Bipolar-I Disorder With Mania or Mania With Mixed Features

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.

Yiru Fang, M.D., Ph.D. principal investigator

Shanghai Mental Health Center

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 Lithium, Quetiapine and Shuganjieyu capsule in people with Bipolar Disorder, run by Shanghai Mental Health Center 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Oct 2017. 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?

Results are not available in the source record.

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?

The change of HAM-D total score only for the phase I (time frame: baseline and 8 weeks). The study lists 2 primary outcomes in all. 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 NCT01938859.

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 5 Oct 2017.