Bipolar I DepressionPhase 3NCT04383691
A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression
A Phase 3 study testing Lurasidone HCl in people with Bipolar I Depression, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 26 sites in China.
Trial summary
The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar I Depression
- What is being tested?
- Lurasidone HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 26 sitesChina
- Study dates
- 11 Dec 2020to 23 Dec 2022
- Phase
- Phase 3
- 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
- Patients who have provided written voluntary consent in person after receiving and understanding adequate explanation about the study, including the objectives, content, expected therapeutic and pharmacological effects, and risks.
- Outpatients who are aged 18 through 65 years at time of informed consent.
- Patients with bipolar I disorder, most recent episode depressed, without rapid cycling disease course ( no less than 4 episodes of mood disturbance in the 12 months prior to screening), and without psychotic features (diagnosed by DSM-5 criteria).
Who cannot join
None listed.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Hebei Provincal Mental Health Center
Baoding, Hebei, 0711028
Beijing Anding Hospital capital medical university
Beijing, Beijing Municipality, 100088
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, 100096
Peking University 6th Hospital
Beijing, Beijing Municipality, 100191
Brain Hospital of Hunan Province
Changsha, Hunan, 410000
The forth People's Hospital of Chengdu
Chengdu, Sichuan, 610036
Chongqing Mental Health Center
Chongqing, Chongqing Municipality, 400036
Dalian Seventh People's Hospital
Dalian, Liaoning, 116086
Guangzhou Huiai Hospital
Guangzhou, Guangdong, 510370
The 1st Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310003
Jining Psychiatric prevention and treatment hospital
Jining, Shandong, 272000
Nanjing Brain Hospital
Nanjing, Jiangsu, 210029
Ningbo Kangning Hospital
Ningbo, Jiangsu, 315201
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065
Shenzhen Kangning Hospital
Shenzhen, Guang, 518118
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300074
Urumqi 4th People's Hospital
Ürümqi, Xinjiang, 830002
The 1st Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Wuhan Mental Health Center
Wuhan, Hubei, 430022
Wuxi Mental Health Center
Wuxi, Jiangsu, 214151
Mental Health Center of Xi'an City
Xi’an, Shanxi, 710061
Xiamen Xianyue Hospital
Xiamen, Fujian, 101191
The 2nd Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 464000
Zhenjiang mental health center
Zhenjiang, Jiangsu, 212001
Zhumadian Psychiatric Hospital
Zhumadian, Henan, 453000
About this study
Official title: A Randomized, 6-Week, Multicenter, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression
The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.
Read the detailed description
The primary objective is to compare the efficacy of lurasidone (20-120 mg/day) monotherapy with that of placebo in patients with Bipolar I Depression by assessing the change from baseline in the MADRS total score at Week 6.
- Conditions
- Bipolar I Depression
- Being tested
- Lurasidone HCl, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurasidone HClDrug
Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. Flexible dosing of study drug will be permitted beginning on Day 8.
PlaceboDrug
Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone | Experimental | Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. Flexible dosing of study drug will be permitted beginning on Day 8. Receives: Drug: Lurasidone HCl |
| Placebo | Placebo comparator | Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the MADRS total score at Week 6
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.
Measured: Baseline/ week 6
Secondary outcomes (1)
Change from baseline in the CGI-BP-S (depression) score at Week 6
Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 1 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
Measured: Baseline/ week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start11 Dec 2020
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Why it stopped: Company's business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DepressionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Sponsor
- Investigators
- Gang Wang, Doctor, Principal investigator, Beijing Anding Hospital capital medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383691
- Sponsor's protocol ID
- D1071301
- Status last verified
- Jan 2023
- First submitted
- 16 Apr 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 6-Week, Multicenter, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression
- ClinicalTrials.gov ID
- NCT04383691
- Acronym / sponsor ID
- D1071301
- Conditions
- Bipolar I Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company's business decision
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 12 May 2020 (actual)
- 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 study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.
Detailed description
The primary objective is to compare the efficacy of lurasidone (20-120 mg/day) monotherapy with that of placebo in patients with Bipolar I Depression by assessing the change from baseline in the MADRS total score at Week 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lurasidone | Experimental | Drug: Lurasidone HClSubjects will be administered orally, once daily, in the evening. Subjects will be treated with Lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. Flexible dosing of study drug will be permitted beginning on Day 8. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have provided written voluntary consent in person after receiving and understanding adequate explanation about the study, including the objectives, content, expected therapeutic and pharmacological effects, and risks.
- Outpatients who are aged 18 through 65 years at time of informed consent.
- Patients with bipolar I disorder, most recent episode depressed, without rapid cycling disease course ( no less than 4 episodes of mood disturbance in the 12 months prior to screening), and without psychotic features (diagnosed by DSM-5 criteria).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lurasidone HClSubjects will be administered orally, once daily, in the evening. Subjects will be treated with Lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. Flexible dosing of study drug will be permitted beginning on Day 8. | Drug | Lurasidone |
| PlaceboSubjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo. | Drug | Placebo |
Primary outcome
Change from baseline in the MADRS total score at Week 6
Time frame: Baseline/ week 6
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.
1 secondary outcome
Change from baseline in the CGI-BP-S (depression) score at Week 6
Time frame: Baseline/ week 6
Results and safety
The study was stopped early (reason given: Company's business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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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.
Gang Wang, Doctor principal investigator
Beijing Anding Hospital capital medical university
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lurasidone HCl in people with Bipolar I Depression, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 26 sites 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 3 inclusion and 0 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: stopped early, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Company's business decision). 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?
Change from baseline in the MADRS total score at Week 6 (time frame: Baseline/ week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2023.