Manic EpisodeNCT05622552
Effect of tDCS Combined With Pharmacological Treatments for Bipolar Mania
A study testing active group of tDCS in people with Manic Episode, run by Dongbin Lyu at 1 site in China.
Trial summary
The goal of this clinical trial is to conduct a randomized double-blind controlled trial to explore the efficacy and safety of transcranial direct current stimulation (tDCS) in the treatment of manic episode (ME) and analyzes the brain functional connectivity to construct the therapeutic effect prediction model of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Manic Episode
- What is being tested?
- active group of tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- 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
- 1. Manic episode in patient with bipolar disorder, as assessed by the Structured Clinical Interview for DSM-IV, Axis I Disorders, Patient Version (SCID-I/P).
- 2. Young Mania Rating Scale (YMRS) score above or equal 13.
- 3. Patients of both genders between 18 and 65 years of age (when obtaining informed consent) ,right-handed.
- 4. Junior high school education and above, with understanding of the content of the study.
- 5. Written, informed and competent consent was obtained before participation in the study.
- 6. The regimens and dosages of mood stabilizers and atypical antipsychotics remained stable from the start of tDCS to the completion of 10 tDCS sessions. One mood stabilizer and/or one atypical antipsychotics could be administered, and no new or discontinued drugs were added
- 7. Did not receive other trials of neurostimulation treatments (include tCS, rTMS, MECT.etc) and psychotherapies 1 month before tDCS treatment to 2 weeks after the end of treatment.
- 8. Benzodiazepines and antidepressants were not used from 1 month before tDCS treatment to 2 weeks after the end of treatment.
Who cannot join
- 1. Laboratory abnormalities that are judged to be clinically significant and that clinicians consider to affect the efficacy of the trial or the safety of the subjects.
- 2. With severe or unstable diseases, including: Patients with neurological diseases (delirium, dementia, stroke, epilepsy, migraine, high intracranial pressure, craniocerebral surgery, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), apnea syndrome, malignant tumors, immunocompromised subjects, acute or chronic liver and kidney failure, cirrhosis or active liver disease, Or blood glucose higher than 12mmol/L.
- 3.Alcohol or drug dependence within 6 months before the trial.
- 4.Pregnant and lactating women. Male and female subjects who are not using effective contraception or who plan to become pregnant within 3 months of starting the trial.
- 5.Family history of epilepsy (within three generations).
- 6.History of head trauma or craniocerebral surgery such as open wound or skull repair.
- 7.Other conditions that were not appropriate for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
Weichieh Yang, MBBS contact
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Donbin Lyu, +86 64387250, shuiysuper@foxmail.com
Weichieh Yang, +86 13701635337, weichieh_yang@163.com
About this study
Official title: Study on the Efficacy of tDCS Combined With Pharmacological Treatments on Manic Episodes and Its Effect on Brain Function
The goal of this clinical trial is to conduct a randomized double-blind controlled trial to explore the efficacy and safety of transcranial direct current stimulation (tDCS) in the treatment of manic episode (ME) and analyzes the brain functional connectivity to construct the therapeutic effect prediction model of tDCS for ME.
The main questions it aims to answer are:
Read more
- A randomized double-blind controlled trial is conducted to clarify the efficacy and safety of tDCS combined with pharmacological treatments in the ME.
- A therapeutic effect prediction model of tDCS for ME by using functional near-infrared spectroscopy to evaluate brain function.
Participants will be receive:
- clinical data interview and clinical symptom assessment.
- the functional near-infrared spectroscopy (fNIRS) to analysis brain functional connectivity.
- tDCS stimulation, which was performed once a day sessions of active or sham anodal tDCS to the right dorsolateral prefrontal cortex and Cathode to the left OFC (2 mA, 20 minutes, 10 sessions).
In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days. For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS.
Read the detailed description
Manic Episode (ME) is a form of bipolar disorder, characterized by a distinct period of abnormally and persistently elevated, expansive, or irritable mood and abnormally and persistently increased goal-directed activity or energy, lasting at least 1 week and present most of the day, nearly every day (or any duration if hospitalization is necessary). Transcranial direct current stimulation (tDCS), which uses weak current to stimulate specific brain areas, is a non-invasion neuromodulation.
This study intends to conduct a randomized double-blind controlled trial to explore the efficacy and safety of right dorsolateral prefrontal cortex stimulation (R-DLPFC) in the treatment of ME. In addition, the brain functional connectivity was analyzed by machine learning analysis based on the brain function detection data, and the therapeutic effect prediction model of tDCS for ME was constructed to provide a basis for the precise navigation and individualized treatment of ME by tDCS.
70 patients with manic episode diagnosed by the Structured Clinical Interview for DSM-IV, Axis I Disorders, Patient Version (SCID-I/P) were recruited from the Shanghai Mental Health Center. Written, informed and competent consent was obtained before their participation in the study and a structured interview would be completed.
After strict inclusion and exclusion criteria for participants, clinical data interview and clinical symptom assessment will be conducted by a trained psychiatrists at the Shanghai Mental Health Center. And the functional near-infrared spectroscopy (fNIRS) would be used to analysis brain functional connectivity at the baseline and the end of the 10 seesions. The study would randomize all participants in a 1:1 ratio, one was "active group", and the other was "sham group". The anode of tDCS was placed over right dorsolateral prefrontal cortex (R-DLPFC) and the cathode to the left orbitofrontal cortex (OFC). In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days. For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS. The study was 8 weeks long, and procedure of visit would be occurred at the following time points: baseline, week 2, 4 and 8.At each visit, psychometric outcome measures including the Young Manic Rating Scale (YMRS), Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology (QIDS SR-16), Altman Self-Rating Mania Scale (ASRM), Wisconsin Card Sorting Test (WCST), Stroop Color Word Test, Morisky Medication Adherence Scale-8 (MMAS-8), Global Assessment of Functioning (GAF).The reduction in YMRS after 10 sessions of tDCS was the primary outcome.
The study will require active reporting of adverse effects from the participants, as well as reports from observations of researchers.
- Conditions
- Manic Episode
- Being tested
- active group of tDCS, sham group of tDCS
- Keywords
- manic episode, Transcranial direct current stimulation, tDCS, Functional near-infrared spectroscopy, fNIRS
- Medical subject headings
- Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active group of tDCSDevice
Transcranial direct current stimulation(tDCS) is a neurostimulation that has aroused concern in psychiatry. As a non-invasive brain modulation that delivered a weak direct current (0.5-2 mA) via two scalp electrodes (an anode and a cathode) overlying targeted cortical areas. It can produce polarity-dependent effects, like inducing functional changes in resting membrane potential and cerebral blood flow. Specifically, a depolarization of the neurons membranes by anodal stimulation and thus invokes an increase of the spontaneous neuronal firing rate, whereas cathodal stimulation induces neuronal hyperpolarization.
In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days.
sham group of tDCSDevice
Transcranial direct current stimulation(tDCS) is a neurostimulation that has aroused concern in psychiatry. As a non-invasive brain modulation that delivered a weak direct current (0.5-2 mA) via two scalp electrodes (an anode and a cathode) overlying targeted cortical areas. It can produce polarity-dependent effects, like inducing functional changes in resting membrane potential and cerebral blood flow. Specifically, a depolarization of the neurons membranes by anodal stimulation and thus invokes an increase of the spontaneous neuronal firing rate, whereas cathodal stimulation induces neuronal hyperpolarization.
For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS.
| Study group | Role | What they receive |
|---|---|---|
| active group | Active comparator | tDCS stimulation, which was performed once a day sessions of active anodal tDCS to the right dorsolateral prefrontal cortex and cathode to the left OFC (2 mA, 20 minutes, 10 sessions over 2 weeks).
In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days. Receives: Device: active group of tDCS |
| sham group | Sham comparator | tDCS stimulation, which was performed once a day sessions of sham anodal tDCS to the right dorsolateral prefrontal cortex and cathode to the left OFC (2 mA, 20 minutes, 10 sessions over 2 weeks).
For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS. Receives: Device: sham group of tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
the reduction in YMRS after two weeks of study
Young Manic Rating Scale (YMRS), as the most widely used assessment tool for severity of manic symptoms in bipolar patients. We used it to assess the symptoms of mania in subjects and calculated the reduction from the scores before and after 2 weeks of treatment. The response was defined as >50% reduction in YMRS after two weeks of study.
Measured: two weeks of study
Secondary outcomes (7)
the scale of MADRS
Montgomery-Åsberg Depression Rating Scale (MADRS), used to evaluate the depressive symptom in mood disorder.
Measured: each visit of study in 8 weeks
the scale of QIDS-16
SR16 is a professional, systematic, and very rigorous self-rating scale, which is characterized by simplicity and clarity, and can quickly understand the degree of depression through this questionnaire.
Measured: each visit of study in 8 weeks
the scale of ASRM
Altman Self-Rating Mania Scale (ASRM), is a 5-item self rating mania scale, designed to assess the presence and/or severity of manic symptoms.
Measured: each visit of study in 8 weeks
the scale of WCST
Wisconsin Card Sorting Test (WCST) is a neuropsychological test that is frequently used to measure such higher-level cognitive processes as attention, perseverance, WM, abstract thinking, CF, and set shifting.
Measured: each visit of study in 8 weeks
the scale of Stroop Color Word Test
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference.
Measured: each visit of study in 8 weeks
the scale of MMAS-8
The Morisky Medication Adherence Scale (MMAS) is a validated assessment tool used to measure non-adherence in a variety of patient populations.
Measured: each visit of study in 8 weeks
the scale of GAF
The Global Assessment of Functioning (GAF) is a number between 0 and 100 that summarizes the clinician's view of the patient's current degree of impairment in terms of psychosocial and occupational or educational function.
Measured: each visit of study in 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manic EpisodeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- tDCS stimulation, which was performed once a day sessions of active or sham anodal tDCS to the right dorsolateral prefrontal cortex and cathode to the left OFC (2 mA, 20 minutes, 10 sessions). In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days. For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongbin Lyu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongbin Lyu, Shanghai Mental Health Center
- Investigators
- Dongbin Lyu, MBBS, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622552
- Sponsor's protocol ID
- 2021-YJ12
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of tDCS Combined With Pharmacological Treatments on Manic Episodes and Its Effect on Brain Function
- ClinicalTrials.gov ID
- NCT05622552
- Acronym / sponsor ID
- 2021-YJ12
- Conditions
- Manic Episode
- Keywords
- manic episode, Transcranial direct current stimulation, tDCS, Functional near-infrared spectroscopy, fNIRS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dongbin LyuUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Nov 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.
The goal of this clinical trial is to conduct a randomized double-blind controlled trial to explore the efficacy and safety of transcranial direct current stimulation (tDCS) in the treatment of manic episode (ME) and analyzes the brain functional connectivity to construct the therapeutic effect prediction model of tDCS for ME.
The main questions it aims to answer are:
- A randomized double-blind controlled trial is conducted to clarify the efficacy and safety of tDCS combined with pharmacological treatments in the ME.
- A therapeutic effect prediction model of tDCS for ME by using functional near-infrared spectroscopy to evaluate brain function.
Participants will be receive:
- clinical data interview and clinical symptom assessment.
- the functional near-infrared spectroscopy (fNIRS) to analysis brain functional connectivity.
- tDCS stimulation, which was performed once a day sessions of active or sham anodal tDCS to the right dorsolateral prefrontal cortex and Cathode to the left OFC (2 mA, 20 minutes, 10 sessions).
In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days. For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS.
Detailed description
Manic Episode (ME) is a form of bipolar disorder, characterized by a distinct period of abnormally and persistently elevated, expansive, or irritable mood and abnormally and persistently increased goal-directed activity or energy, lasting at least 1 week and present most of the day, nearly every day (or any duration if hospitalization is necessary). Transcranial direct current stimulation (tDCS), which uses weak current to stimulate specific brain areas, is a non-invasion neuromodulation.
This study intends to conduct a randomized double-blind controlled trial to explore the efficacy and safety of right dorsolateral prefrontal cortex stimulation (R-DLPFC) in the treatment of ME. In addition, the brain functional connectivity was analyzed by machine learning analysis based on the brain function detection data, and the therapeutic effect prediction model of tDCS for ME was constructed to provide a basis for the precise navigation and individualized treatment of ME by tDCS.
70 patients with manic episode diagnosed by the Structured Clinical Interview for DSM-IV, Axis I Disorders, Patient Version (SCID-I/P) were recruited from the Shanghai Mental Health Center. Written, informed and competent consent was obtained before their participation in the study and a structured interview would be completed.
After strict inclusion and exclusion criteria for participants, clinical data interview and clinical symptom assessment will be conducted by a trained psychiatrists at the Shanghai Mental Health Center. And the functional near-infrared spectroscopy (fNIRS) would be used to analysis brain functional connectivity at the baseline and the end of the 10 seesions. The study would randomize all participants in a 1:1 ratio, one was "active group", and the other was "sham group". The anode of tDCS was placed over right dorsolateral prefrontal cortex (R-DLPFC) and the cathode to the left orbitofrontal cortex (OFC). In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days. For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS. The study was 8 weeks long, and procedure of visit would be occurred at the following time points: baseline, week 2, 4 and 8.At each visit, psychometric outcome measures including the Young Manic Rating Scale (YMRS), Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology (QIDS SR-16), Altman Self-Rating Mania Scale (ASRM), Wisconsin Card Sorting Test (WCST), Stroop Color Word Test, Morisky Medication Adherence Scale-8 (MMAS-8), Global Assessment of Functioning (GAF).The reduction in YMRS after 10 sessions of tDCS was the primary outcome.
The study will require active reporting of adverse effects from the participants, as well as reports from observations of researchers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- tDCS stimulation, which was performed once a day sessions of active or sham anodal tDCS to the right dorsolateral prefrontal cortex and cathode to the left OFC (2 mA, 20 minutes, 10 sessions). In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days. For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS.
| Arm | Type | Receives |
|---|---|---|
| active group | Active comparator | Device: active group of tDCStDCS stimulation, which was performed once a day sessions of active anodal tDCS to the right dorsolateral prefrontal cortex and cathode to the left OFC (2 mA, 20 minutes, 10 sessions over 2 weeks). In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days. |
| sham group | Sham comparator | Device: sham group of tDCStDCS stimulation, which was performed once a day sessions of sham anodal tDCS to the right dorsolateral prefrontal cortex and cathode to the left OFC (2 mA, 20 minutes, 10 sessions over 2 weeks). For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Manic episode in patient with bipolar disorder, as assessed by the Structured Clinical Interview for DSM-IV, Axis I Disorders, Patient Version (SCID-I/P).
- 2. Young Mania Rating Scale (YMRS) score above or equal 13.
- 3. Patients of both genders between 18 and 65 years of age (when obtaining informed consent) ,right-handed.
- 4. Junior high school education and above, with understanding of the content of the study.
- 5. Written, informed and competent consent was obtained before participation in the study.
Key exclusion criteria (7 listed)
- 1. Laboratory abnormalities that are judged to be clinically significant and that clinicians consider to affect the efficacy of the trial or the safety of the subjects.
- 2. With severe or unstable diseases, including: Patients with neurological diseases (delirium, dementia, stroke, epilepsy, migraine, high intracranial pressure, craniocerebral surgery, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), apnea syndrome, malignant tumors, immunocompromised subjects, acute or chronic liver and kidney failure, cirrhosis or active liver disease, Or blood glucose higher than 12mmol/L.
- 3.Alcohol or drug dependence within 6 months before the trial.
- 4.Pregnant and lactating women. Male and female subjects who are not using effective contraception or who plan to become pregnant within 3 months of starting the trial.
- 5.Family history of epilepsy (within three generations).
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 |
|---|---|---|
| active group of tDCSTranscranial direct current stimulation(tDCS) is a neurostimulation that has aroused concern in psychiatry. As a non-invasive brain modulation that delivered a weak direct current (0.5-2 mA) via two scalp electrodes (an anode and a cathode) overlying targeted cortical areas. It can produce polarity-dependent effects, like inducing functional changes in resting membrane potential and cerebral blood flow. Specifically, a depolarization of the neurons membranes by anodal stimulation and thus invokes an increase of the spontaneous neuronal firing rate, whereas cathodal stimulation induces neuronal hyperpolarization. In the active group, current stimulations were gradually ramped up to 2 mA (in 30 seconds) intensity for 20 minutes, once a day, for 10 days. | Device | active group |
| sham group of tDCSTranscranial direct current stimulation(tDCS) is a neurostimulation that has aroused concern in psychiatry. As a non-invasive brain modulation that delivered a weak direct current (0.5-2 mA) via two scalp electrodes (an anode and a cathode) overlying targeted cortical areas. It can produce polarity-dependent effects, like inducing functional changes in resting membrane potential and cerebral blood flow. Specifically, a depolarization of the neurons membranes by anodal stimulation and thus invokes an increase of the spontaneous neuronal firing rate, whereas cathodal stimulation induces neuronal hyperpolarization. For sham stimulation, the procedure was identical, except that the current was gradually ramped up to 2mA and rapidly down to zero (in 30 seconds), thus leading to the same initial sensations of tDCS. | Device | sham group |
Primary outcome
the reduction in YMRS after two weeks of study
Time frame: two weeks of study
Young Manic Rating Scale (YMRS), as the most widely used assessment tool for severity of manic symptoms in bipolar patients. We used it to assess the symptoms of mania in subjects and calculated the reduction from the scores before and after 2 weeks of treatment. The response was defined as >50% reduction in YMRS after two weeks of study.
7 secondary outcomes
the scale of MADRS
Time frame: each visit of study in 8 weeks
the scale of QIDS-16
Time frame: each visit of study in 8 weeks
the scale of ASRM
Time frame: each visit of study in 8 weeks
the scale of WCST
Time frame: each visit of study in 8 weeks
the scale of Stroop Color Word Test
Time frame: each visit of study in 8 weeks
the scale of MMAS-8
Time frame: each visit of study in 8 weeks
the scale of GAF
Time frame: each visit of study in 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
Weichieh Yang, MBBS contact
Dongbin Lyu, MBBS 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 study testing active group of tDCS in people with Manic Episode, run by Dongbin Lyu 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 18 Nov 2022. 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. 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.
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 Dongbin Lyu, MBBS (+86 64387250, shuiysuper@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the reduction in YMRS after two weeks of study (time frame: two weeks of study). 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 18 Nov 2022.