Depressive DisorderPhase 4NCT04826510
Efficacy and Safety of Peropirone Hydrochloride Tablets in the Treatment of Adolescent Bipolar Disorder Depression
A Phase 4 study testing Perospirone hydrochloride tablets, Lithium carbonate + perospirone hydrochloride and Lithium Carbonate Pill in people with Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Bipolar disorder, a type of mood disorder that occurs in various forms, such as depression, mania, hypomania or irregularity.According to the World Health Organization mental health survey, the lifetime prevalence of bipolar disorder is 2.4%; the 12-month prevalence was 1.5%. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Perospirone hydrochloride tablets, Lithium carbonate + perospirone hydrochloride and Lithium Carbonate Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2020to 30 Jun 2021
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Outpatients or inpatients who met the diagnostic criteria of DSM-5 or ICD-10 for depressive episode of bipolar disorder.
- Willing to participate in clinical research and sign informed consent
- 12 ≤ age ≤ 18
- HAMD-17 score ≥ 17; HAMD-17 item 1 (depression) ≥ 2, and YMRS ≤ 12
- Physical examination, laboratory examination, vital signs and 12 lead ECG showed that the physical condition was stable. If any test results are beyond the normal range, they can be included only if they are judged to be abnormal or deviated from the normal values but have no clinical significance or belong to reasonable conditions in the study population. Such decisions must be recorded in the subject's original file and signed by the researcher
Who cannot join
- Besides bipolar disorder, the diagnosis includes schizophrenia, schizophrenic affective disorder, schizoid disorder, depression, dissociation disorder, borderline personality disorder, material dependence, autism, organic mental disease, etc
- Other conditions except bipolar disorder were diagnosed, such as schizophrenia, schizophrenic affective disorder, schizophrenia like disorder, depression, dissociation disorder, borderline personality disorder, material dependence, autism, organic mental disease, etc. according to the judgment of the researcher, the patient is at risk of suicide or injury to others, or HAMD-17 item 3 Score ≥ 3, or attempted suicide in the past six months
- Patients with rapid circulation type;
- Those who had suffered from serious heart, liver, brain, lung, kidney and other serious diseases in the past or at present, and the researchers considered that they were not suitable for the study;
- The results of Biochemistry, hematology, electrocardiogram or urine test were not within the normal value range of the laboratory at the time of screening, and had clinical significance according to the judgment of the researchers (except for the abnormal indexes of reasonable condition in the research population, such as abnormal blood glucose and blood lipid indexes);
- The subjects received electroconvulsive therapy (ECT) within 6 months before enrollment;
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- There was a history of malignant tumor or complications;
- Known allergy history or complications to test drug or ingredient (with previous history of allergic reaction caused by drug, rash, urticaria, etc.);
- Pregnant and lactating women and patients unable to take appropriate contraceptive measures during the trial period;
- Patients with previous suicidal behavior or existing strong suicidal tendency and patients with serious excited and aggressive behavior.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Yiru Fang, M.D., Ph.D., (86) 18017311133, yirufang@gmail.com
Yiru Fang, M.D., Ph.D.
About this study
Official title: Objective to Evaluate the Efficacy and Safety of Peropirone Hydrochloride Tablets in the Treatment of Adolescent Bipolar Depressive Episode: a Multicenter Open Randomized Controlled Clinical Trial
Bipolar disorder, a type of mood disorder that occurs in various forms, such as depression, mania, hypomania or irregularity.According to the World Health Organization mental health survey, the lifetime prevalence of bipolar disorder is 2.4%; the 12-month prevalence was 1.5%. The lifetime incidence in Shenzhen was 1.5%, and the 12-month incidence was 1.1%. In another study in Hong Kong, the 12-month prevalence of bipolar I, II, and "soft" II was 1.4%, 0.5%, and 1.8%, respectively. Due to endocrine effects, bipolar disorder is more common in women than men, and mainly occurs in late adolescence and early adulthood, with an early trend. An investigation involving 23 countries around the world found that the average age of onset of bipolar disorder was 25 years old, and the low age group (17.24±3.20 years old) accounted for 41.7%. Another study in the United States showed that the average age of onset of bipolar disorder was 20 years old, and the low age group (14.5±4.9 years old) accounted for 63%. With the improvement of medical level, the diagnosis rate of bipolar disorder is getting closer to the true prevalence rate.
Without active treatment, the symptoms of bipolar disorder, especially depression, will accompany the patients for a long time. The quality of life of patients is seriously affected.
The safety of piperopilon hydrochloride has been widely recognized from pre-market clinical research to post-market clinical practice. A total of a clinical study involving 1191 patients showed that the incidence of side effects from long-term use of piperopilone was 21.3%, and the main side effects were mild in the nervous and digestive systems. In addition, it has been reported that piperopirone is also safe and effective for adolescents.Therefore, the investigators designed this study to explore the atypical antipsychotic drug piperopirone as a monotherapy or in combination with mood stabilizer.Clinical efficacy and safety of lithium acid in the treatment of depressive episodes in adolescents with bipolar disorder, and its improvement in cognitive function were assessed.The goal is to evaluate the efficacy and safety of piperopilone hydrochloride tablets in the treatment of bipolar depressive episode in adolescents.
Read the detailed description
Participants will be randomly assigned to the lithium carbonate group, piperopirone hydrochloride group or the lithium carbonate + Piperopirone hydrochloride group after obtaining the corresponding random number according to the order of inclusion. According to the random centers, the lithium carbonate group: piperopirone hydrochloride group: lithium carbonate + Piperopirone hydrochloride group was 1:1:1
- Conditions
- Depressive Disorder
- Being tested
- Perospirone hydrochloride tablets, Lithium carbonate + perospirone hydrochloride, Lithium Carbonate Pill
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perospirone hydrochloride tabletsDrug
The dosage of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks.
Lithium carbonate + perospirone hydrochlorideDrug
The stable blood lithium concentration was 0.5-1.2 mmol / L, and the dose of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks.
Lithium Carbonate PillDrug
Lithium carbonate treatment, stable blood lithium concentration 0.5-1.2 mmol / L, course of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lithium carbonate group | Active comparator | Lithium carbonate treatment, stable blood lithium concentration 0.5-1.2 mmol / L, course of 8 weeks. Receives: Drug: Lithium Carbonate Pill |
| Perospirone hydrochloride group | Experimental | The dosage of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks. Receives: Drug: Perospirone hydrochloride tablets |
| Lithium carbonate + perospirone hydrochloride group | Experimental | The stable blood lithium concentration was 0.5-1.2 mmol / L, and the dose of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks. Receives: Drug: Lithium carbonate + perospirone hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Scale-Bipolar Disorder Scale (CGI-BP-S) score
The investigators adopt the clinical General Impression Scale - Bipolar Disorder Scale (CGI-BP-S) score to analyze the scores of the subjects in different periods.
Measured: Change from baseline at 2,4,8 week.
Hamilton Depression Scale (HAMD-17) score
The investigators adopt the Hamilton Depression Scale (HAMD-17) score to judge the subjects' depression. Starting points: Hamilton Depression Scale (HAMD-17)) ≥2, clinical remission: Hamilton Depression Scale (HAMD-17)) <7.
Measured: Change from baseline at 2,4,8 week.
Secondary outcomes (4)
Young's Manic Rating Scale (YMRS) score
Young's Manic Rating Scale (YMRS) was used to determine the degree of mania in the subjects. Initial score: Young's Manic Rating Scale (YMRS) score ≤12; Clinical remission: Young's Manic Rating Scale (YMRS) score ≤5.
Measured: Change from baseline at 2,4,8 week.
Montreal Cognitive Assessment Scale (MoCA) score
The investigators adopt the Montreal cognitive assessment scale (MoCA) score to judge whether the subjects with normal cognition and affect its subsequent different drugs.
Measured: Change from baseline at 8 week.
Wisconsin Card Sorting Test (WCST-128) score
The investigators used the Wisconsin Card Sorting Test (WCST-128) score to determine whether the subjects had normal cognition. Reference value: total response number < 60: indicating cognitive abnormalities; Incorrect response number > 45: indicates cognitive abnormality
Measured: Change from baseline at 8 week.
WISC score for Children
WISC Score for Children was used to determine whether subjects' IQ was affected by their disease. Reference value: 1. Low: Total IQ score ≤90; 2. Normal: Total IQ score is 90-110; High IQ: total IQ score ≥110
Measured: Change from baseline at 8 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start25 Nov 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Model description
- The study is expected in the nine and clinical study of cooperative unit to carry out clinical research network, each is expected to include subjects about 21 cases (7 cases of lithium carbonate group, pp horse of the 7 cases, hydrochloric acid hydrochloric acid lithium carbonate + pp ROM horse lung group of 7 cases), with 189 recruit subjects (lithium carbonate group 63 examples, hydrochloric acid pp ROM horse lung group 63 examples, lithium carbonate + pp hydrochloride horse lung group 63 examples. The study is expected to be completed within two years.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiru Fang, professor, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826510
- Sponsor's protocol ID
- 3.0
- Status last verified
- Sep 2020
- First submitted
- 31 Jan 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the trial is over, after obtaining the written consent of the sponsor, the research unit can publish the research results of this clinical trial in the form of a paper, but the source of the drug must be stated. The investigator of each research unit has the right to sign the paper. ponsors can also publish papers or use experimental content, or participate in signing
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective to Evaluate the Efficacy and Safety of Peropirone Hydrochloride Tablets in the Treatment of Adolescent Bipolar Depressive Episode: a Multicenter Open Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04826510
- Acronym / sponsor ID
- 3.0
- Conditions
- Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 1 Apr 2021 (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.
Bipolar disorder, a type of mood disorder that occurs in various forms, such as depression, mania, hypomania or irregularity.According to the World Health Organization mental health survey, the lifetime prevalence of bipolar disorder is 2.4%; the 12-month prevalence was 1.5%. The lifetime incidence in Shenzhen was 1.5%, and the 12-month incidence was 1.1%. In another study in Hong Kong, the 12-month prevalence of bipolar I, II, and "soft" II was 1.4%, 0.5%, and 1.8%, respectively. Due to endocrine effects, bipolar disorder is more common in women than men, and mainly occurs in late adolescence and early adulthood, with an early trend. An investigation involving 23 countries around the world found that the average age of onset of bipolar disorder was 25 years old, and the low age group (17.24±3.20 years old) accounted for 41.7%. Another study in the United States showed that the average age of onset of bipolar disorder was 20 years old, and the low age group (14.5±4.9 years old) accounted for 63%. With the improvement of medical level, the diagnosis rate of bipolar disorder is getting closer to the true prevalence rate.
Without active treatment, the symptoms of bipolar disorder, especially depression, will accompany the patients for a long time. The quality of life of patients is seriously affected.
The safety of piperopilon hydrochloride has been widely recognized from pre-market clinical research to post-market clinical practice. A total of a clinical study involving 1191 patients showed that the incidence of side effects from long-term use of piperopilone was 21.3%, and the main side effects were mild in the nervous and digestive systems. In addition, it has been reported that piperopirone is also safe and effective for adolescents.Therefore, the investigators designed this study to explore the atypical antipsychotic drug piperopirone as a monotherapy or in combination with mood stabilizer.Clinical efficacy and safety of lithium acid in the treatment of depressive episodes in adolescents with bipolar disorder, and its improvement in cognitive function were assessed.The goal is to evaluate the efficacy and safety of piperopilone hydrochloride tablets in the treatment of bipolar depressive episode in adolescents.
Detailed description
Participants will be randomly assigned to the lithium carbonate group, piperopirone hydrochloride group or the lithium carbonate + Piperopirone hydrochloride group after obtaining the corresponding random number according to the order of inclusion. According to the random centers, the lithium carbonate group: piperopirone hydrochloride group: lithium carbonate + Piperopirone hydrochloride group was 1:1:1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is expected in the nine and clinical study of cooperative unit to carry out clinical research network, each is expected to include subjects about 21 cases (7 cases of lithium carbonate group, pp horse of the 7 cases, hydrochloric acid hydrochloric acid lithium carbonate + pp ROM horse lung group of 7 cases), with 189 recruit subjects (lithium carbonate group 63 examples, hydrochloric acid pp ROM horse lung group 63 examples, lithium carbonate + pp hydrochloride horse lung group 63 examples. The study is expected to be completed within two years.
| Arm | Type | Receives |
|---|---|---|
| Lithium carbonate group | Active comparator | Drug: Lithium Carbonate PillLithium carbonate treatment, stable blood lithium concentration 0.5-1.2 mmol / L, course of 8 weeks. |
| Perospirone hydrochloride group | Experimental | Drug: Perospirone hydrochloride tabletsThe dosage of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks. |
| Lithium carbonate + perospirone hydrochloride group | Experimental | Drug: Lithium carbonate + perospirone hydrochlorideThe stable blood lithium concentration was 0.5-1.2 mmol / L, and the dose of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Outpatients or inpatients who met the diagnostic criteria of DSM-5 or ICD-10 for depressive episode of bipolar disorder.
- Willing to participate in clinical research and sign informed consent
- 12 ≤ age ≤ 18
- HAMD-17 score ≥ 17; HAMD-17 item 1 (depression) ≥ 2, and YMRS ≤ 12
- Physical examination, laboratory examination, vital signs and 12 lead ECG showed that the physical condition was stable. If any test results are beyond the normal range, they can be included only if they are judged to be abnormal or deviated from the normal values but have no clinical significance or belong to reasonable conditions in the study population. Such decisions must be recorded in the subject's original file and signed by the researcher
Key exclusion criteria (10 listed)
- Besides bipolar disorder, the diagnosis includes schizophrenia, schizophrenic affective disorder, schizoid disorder, depression, dissociation disorder, borderline personality disorder, material dependence, autism, organic mental disease, etc
- Other conditions except bipolar disorder were diagnosed, such as schizophrenia, schizophrenic affective disorder, schizophrenia like disorder, depression, dissociation disorder, borderline personality disorder, material dependence, autism, organic mental disease, etc. according to the judgment of the researcher, the patient is at risk of suicide or injury to others, or HAMD-17 item 3 Score ≥ 3, or attempted suicide in the past six months
- Patients with rapid circulation type;
- Those who had suffered from serious heart, liver, brain, lung, kidney and other serious diseases in the past or at present, and the researchers considered that they were not suitable for the study;
- The results of Biochemistry, hematology, electrocardiogram or urine test were not within the normal value range of the laboratory at the time of screening, and had clinical significance according to the judgment of the researchers (except for the abnormal indexes of reasonable condition in the research population, such as abnormal blood glucose and blood lipid indexes);
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 |
|---|---|---|
| Perospirone hydrochloride tabletsThe dosage of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks. | Drug | Perospirone hydrochloride group |
| Lithium carbonate + perospirone hydrochlorideThe stable blood lithium concentration was 0.5-1.2 mmol / L, and the dose of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks. | Drug | Lithium carbonate + perospirone hydrochloride group |
| Lithium Carbonate PillLithium carbonate treatment, stable blood lithium concentration 0.5-1.2 mmol / L, course of 8 weeks. | Drug | Lithium carbonate group |
Primary outcome
Clinical Global Impression Scale-Bipolar Disorder Scale (CGI-BP-S) score
Time frame: Change from baseline at 2,4,8 week.
The investigators adopt the clinical General Impression Scale - Bipolar Disorder Scale (CGI-BP-S) score to analyze the scores of the subjects in different periods.
Hamilton Depression Scale (HAMD-17) score
Time frame: Change from baseline at 2,4,8 week.
The investigators adopt the Hamilton Depression Scale (HAMD-17) score to judge the subjects' depression. Starting points: Hamilton Depression Scale (HAMD-17)) ≥2, clinical remission: Hamilton Depression Scale (HAMD-17)) <7.
4 secondary outcomes
Young's Manic Rating Scale (YMRS) score
Time frame: Change from baseline at 2,4,8 week.
Montreal Cognitive Assessment Scale (MoCA) score
Time frame: Change from baseline at 8 week.
Wisconsin Card Sorting Test (WCST-128) score
Time frame: Change from baseline at 8 week.
WISC score for Children
Time frame: Change from baseline at 8 week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Yes. After the trial is over, after obtaining the written consent of the sponsor, the research unit can publish the research results of this clinical trial in the form of a paper, but the source of the drug must be stated. The investigator of each research unit has the right to sign the paper. ponsors can also publish papers or use experimental content, or participate in signing
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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.
Yiru Fang, professor 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 Perospirone hydrochloride tablets, Lithium carbonate + perospirone hydrochloride and Lithium Carbonate Pill in people with Depressive 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 5 inclusion and 10 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 1 Apr 2021. 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?
Contact Yiru Fang, professor (18017311133, yirufang@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression Scale-Bipolar Disorder Scale (CGI-BP-S) score (time frame: Change from baseline at 2,4,8 week.). 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?
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 1 Apr 2021.