Bipolar DepressionPhase 4VortioxetineNCT05481957
Vortioxetine Adjunctive Treatment in Bipolar Depression
A Phase 4 study testing Vortioxetine and valprote in people with Bipolar Depression, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Depressive episode of bipolar disorder is often the first symptom of patients with bipolar disorder, which is characterized by frequent recurrence, relatively long duration, high comorbidity rate and high fatality rate. Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Vortioxetine and valprote
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 15 Aug 2023
- 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 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- BMI between >18.5 and <29.5 kg
- The MINI-International Neuropsychiatric Interview is adopted and patients selected shall meet the clinical diagnostic criteria stipulated in DSM-5 on clinical diagnostic criteria for type II bipolar depression.
- HDRS17>17
- YMRS score <5;
- No treatment was given before enrollment;
- All patients and their family members were informed and agreed to this trial.
Who cannot join
- Those who suffering from other severe mental diseases;
- Those who suffering from severe somatic diseases;
- Those who had received medication (such as anti-depressants, antipsychotics, mood stabilizers, etc.) within 1 month before enrollment;
- Those who had been treated with ECT one month before enrollment;
- Those who currently have severe suicidal thoughts or behavior, or who are extremely excited and fail to cooperate with;
- Women in pregnancy and lactation;
Show all 9Show fewer
- Patients with contraindications to drugs used in this trial;
- Those who have participated in a clinical trial of an investigational product in the last 60 days
- 10) Substance misuse/abuse
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Clinical Efficacy and Safety of Vortioxetine Combined With Mood Stabilizer in the Treatment of Bipolar Disorder Type II Depression
Depressive episode of bipolar disorder is often the first symptom of patients with bipolar disorder, which is characterized by frequent recurrence, relatively long duration, high comorbidity rate and high fatality rate. People with bipolar disorder spend a third of their lives depressed, and it is these depressive symptoms that lead to long-term disability and early death. The treatment of bipolar depression is controversial. The latest Mood Disorders CPG guidelines recommend first-line therapy: quetiapine, lurasidone, lithium, valproate, lamotrigine monotherapy or combination of quetiapine, lurasidone plus Mood stabilizer, olanzapine plus fluoxetine therapy. In addition, the use of antidepressants is still controversial, and their efficacy, prognosis and risk of mania remain to be evaluated. Vortioxetine is a novel antidepressant with unique characteristics, and its multi-mode mechanism of action can be used to treat a wide spectrum of symptoms of depression. Current clinical experience suggests that the clinical conversion rate of vortioxetine is low, and the depressive symptoms and cognitive symptoms of people with depressive episodes are significantly improved. As of September 2019, a total of 4.87 million patient years (nearly 3 months of treatment with 20 million patients) were treated with vortioxetine in PSUR (Periodic Safety Update), with 51 reported cases of hypomania and 322 reported cases of mania. Based on the above data, the post-marketing conversion rate of vortioxetine is approximately 1 in 10,000 patient-years or 1 in 40,000 patients. Therefore, the efficacy and risk of transferring to mania of vortioxetine in bipolar II depressive episode deserve further investigation.
Read the detailed description
This study initiated by The first affiliated hospital of zhejiang university. Professor Shao-hua Hu will be PI of the study. There are about 80 patients with bipolar II depressive episode were involved in this study, all participants after 4 weeks of monotherapy (quetiapine or lurasidone). Group A: Those patients who were treated effectively over the 4th weekend {Reduction rate of 17 items of the Hamilton Depression Scale (HDS-17) >50%} continued with the original regimen for 4 weeks. Subjects who did not meet valid criteria (HSDRS-17 subscore ratio<50%) were randomly assigned to two treatment groups: group B (quetiapine/lurasidone + vortioxetine tablets) and group C (quetiapine/lurasidone + sodium valproate sustained release tablets). Subjects in group B were given vortioxetine in combination with their original treatment regimen at week 5; Subjects in group C began to receive sodium valproate sustained-release tablets in combination with the original treatment regimen at week 5. All three groups were observed at the end of the 16th week.
Group A: single drug treatment group: quetiapine tablet 300mg~600mg/d or Lurasidone tablet 40-120mg /d; Group B: quetiapine tablets 300mg~600mg/d or Lurasidone tablets 40-120mg /d+ vortioxetine 5-10mg /d Group C: quetiapine tablets 300mg~600mg/d or Lurasidone tablets 40-120mg /d+ sodium valproate sustained release tablets 0.5-1.0 /d Quetiapine or lurasidone is currently the first-line treatment for bipolar II depressive episodes, ensuring effective treatment for all subjects. The study program will last 16 weeks with seven study visits including screening. For the consideration of scientific, legal and ethical factors, 100 subjects are initially planned to be enrolled in this experiment.
- Conditions
- Bipolar Depression
- Being tested
- Vortioxetine, valprote
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Also called Brintellix®
5-10mg for 16 weeks
valproteDrug
Also called Depakine
500~1000mg for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| vortioxetine | Experimental | participants given 5~10mg per day for 16 weeks Receives: Drug: Vortioxetine |
| Sodium valproate | Active comparator | participants given 500~1000mg per day for 16 weeks Receives: Drug: valprote |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale(MADRS)
Montgomery-Asberg Depression Rating Scale(MADRS) score is to evaluate the degree of depression, and the higher score means severer depression. Score frame: 0~60. The higher score means severer depression.
Measured: 0 ~16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Mar 2022
- Primary completion28 Jun 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University
- Responsible party
- Principal investigator, Hu ShaoHua, First Affiliated Hospital of Zhejiang University
- Investigators
- Li YouMing, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481957
- Sponsor's protocol ID
- IIT20210111C-R1
- Acronym
- Vortioxetine
- Status last verified
- Sep 2023
- First submitted
- 28 Jul 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Arms and interventions can be shared, while the clinical data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Vortioxetine Combined With Mood Stabilizer in the Treatment of Bipolar Disorder Type II Depression
- ClinicalTrials.gov ID
- NCT05481957
- Acronym / sponsor ID
- Vortioxetine / IIT20210111C-R1
- Conditions
- Bipolar Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Zhejiang University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 1 Aug 2022 (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.
Depressive episode of bipolar disorder is often the first symptom of patients with bipolar disorder, which is characterized by frequent recurrence, relatively long duration, high comorbidity rate and high fatality rate. People with bipolar disorder spend a third of their lives depressed, and it is these depressive symptoms that lead to long-term disability and early death. The treatment of bipolar depression is controversial. The latest Mood Disorders CPG guidelines recommend first-line therapy: quetiapine, lurasidone, lithium, valproate, lamotrigine monotherapy or combination of quetiapine, lurasidone plus Mood stabilizer, olanzapine plus fluoxetine therapy. In addition, the use of antidepressants is still controversial, and their efficacy, prognosis and risk of mania remain to be evaluated. Vortioxetine is a novel antidepressant with unique characteristics, and its multi-mode mechanism of action can be used to treat a wide spectrum of symptoms of depression. Current clinical experience suggests that the clinical conversion rate of vortioxetine is low, and the depressive symptoms and cognitive symptoms of people with depressive episodes are significantly improved. As of September 2019, a total of 4.87 million patient years (nearly 3 months of treatment with 20 million patients) were treated with vortioxetine in PSUR (Periodic Safety Update), with 51 reported cases of hypomania and 322 reported cases of mania. Based on the above data, the post-marketing conversion rate of vortioxetine is approximately 1 in 10,000 patient-years or 1 in 40,000 patients. Therefore, the efficacy and risk of transferring to mania of vortioxetine in bipolar II depressive episode deserve further investigation.
Detailed description
This study initiated by The first affiliated hospital of zhejiang university. Professor Shao-hua Hu will be PI of the study. There are about 80 patients with bipolar II depressive episode were involved in this study, all participants after 4 weeks of monotherapy (quetiapine or lurasidone). Group A: Those patients who were treated effectively over the 4th weekend {Reduction rate of 17 items of the Hamilton Depression Scale (HDS-17) >50%} continued with the original regimen for 4 weeks. Subjects who did not meet valid criteria (HSDRS-17 subscore ratio<50%) were randomly assigned to two treatment groups: group B (quetiapine/lurasidone + vortioxetine tablets) and group C (quetiapine/lurasidone + sodium valproate sustained release tablets). Subjects in group B were given vortioxetine in combination with their original treatment regimen at week 5; Subjects in group C began to receive sodium valproate sustained-release tablets in combination with the original treatment regimen at week 5. All three groups were observed at the end of the 16th week.
Group A: single drug treatment group: quetiapine tablet 300mg~600mg/d or Lurasidone tablet 40-120mg /d; Group B: quetiapine tablets 300mg~600mg/d or Lurasidone tablets 40-120mg /d+ vortioxetine 5-10mg /d Group C: quetiapine tablets 300mg~600mg/d or Lurasidone tablets 40-120mg /d+ sodium valproate sustained release tablets 0.5-1.0 /d Quetiapine or lurasidone is currently the first-line treatment for bipolar II depressive episodes, ensuring effective treatment for all subjects. The study program will last 16 weeks with seven study visits including screening. For the consideration of scientific, legal and ethical factors, 100 subjects are initially planned to be enrolled in this experiment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vortioxetine | Experimental | Drug: Vortioxetineparticipants given 5~10mg per day for 16 weeks |
| Sodium valproate | Active comparator | Drug: valproteparticipants given 500~1000mg per day for 16 weeks |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- BMI between >18.5 and <29.5 kg
- The MINI-International Neuropsychiatric Interview is adopted and patients selected shall meet the clinical diagnostic criteria stipulated in DSM-5 on clinical diagnostic criteria for type II bipolar depression.
- HDRS17>17
- YMRS score <5;
- No treatment was given before enrollment;
Key exclusion criteria (9 listed)
- Those who suffering from other severe mental diseases;
- Those who suffering from severe somatic diseases;
- Those who had received medication (such as anti-depressants, antipsychotics, mood stabilizers, etc.) within 1 month before enrollment;
- Those who had been treated with ECT one month before enrollment;
- Those who currently have severe suicidal thoughts or behavior, or who are extremely excited and fail to cooperate with;
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 |
|---|---|---|
| VortioxetineAlso: Brintellix®5-10mg for 16 weeks | Drug | vortioxetine |
| valproteAlso: Depakine500~1000mg for 16 weeks | Drug | Sodium valproate |
Primary outcome
Montgomery-Asberg Depression Rating Scale(MADRS)
Time frame: 0 ~16 weeks
Montgomery-Asberg Depression Rating Scale(MADRS) score is to evaluate the degree of depression, and the higher score means severer depression. Score frame: 0~60. The higher score means severer depression.
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 14 Sep 2023.
- Individual participant dataSharing planned: No. Arms and interventions can be shared, while the clinical data will not be shared
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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.
Li YouMing study chair
Zhejiang University
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 Vortioxetine and valprote in people with Bipolar Depression, run by First Affiliated Hospital of Zhejiang University 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 9 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 14 Sep 2023. 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?
Montgomery-Asberg Depression Rating Scale(MADRS) (time frame: 0 ~16 weeks). 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 14 Sep 2023.