Bipolar DisorderNCT04564573
Antidepressant Treatments and Cognitive Function of Bipolar Patients
An observational study of Bipolar Disorder and Cognition, run by Tianjin Anding Hospital at 1 site in China.
Trial summary
Patients with bipolar disorder (BD) have a wide range of neurocognitive dysfunction, which lead to impaired psychosocial function and reduced quality of life. Therefore, improving neurocognitive function has become an important goal of BD treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bipolar Disorder, Cognition
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Oct 2022
- Phase
- Observational
- 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 50 years
- All sexes
- Adult
Study population: This study will consist of a sample of 124 patients with bipolar disorder who initiated with a depressive episode and being a euthymic state for 4 weeks at least before enrollment.All participants are divided into two groups according to whether they had received systemic antidepressant treatment or not in the early stage.
Who may be able to join
- A diagnosis of BD diagnosed according to the Diagnostic and Statistical Manual of Mental disorders, Fourth Edition (DSM-IV-TR) diagnosed with Structured Clinical Interview for DSM-IV (SCID); a current state of euthymia is defined by both scores of Montgomery-Åsberg Depression Scale (MADRS) and Young Manic Rating Scale (YMRS) <7, lasting for 4 weeks at least before recruitment
- Initiated with a depressive episode
- Aged between 18~50 years
- Patients comply with all procedures of study
- Participants must sign the informed consent
Who cannot join
- A history of psychiatric symptoms
- A comorbidity of attention deficit and hyperactivity disorder (ADHD)
- Neurological trauma or neurological diseases which could cause cognition injury
- History of substance dependence/abuse
- Received modified electroconvulsive therapy (MECT) in the past 12 months
- Severe physical disease affecting cognitive function or increasing peripheral NSE
Show all 9Show fewer
- Recent drug use that affects cognition, such as tricyclic antidepressants, anticholinergic drugs, amphetamines, etc.
- IQ <70
- Use benzodiazepines 4 hours before scale evaluation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Anding Hospital
Tianjin
Jie Li, Doctor, jieli@tjmhc.com
About this study
Official title: The Impact of Systemic Antidepressant Treatments in Early Stage on Neurocognitive Function of Euthymic Patients With Bipolar Depression
Patients with bipolar disorder (BD) have a wide range of neurocognitive dysfunction, which lead to impaired psychosocial function and reduced quality of life. Therefore, improving neurocognitive function has become an important goal of BD treatment. Aiming at this, some clinical studies have been performed but failed to illustrate significant positive efficacies of pharmacological therapy or non-pharmacological therapy, which could attribute in part to insufficient understanding on the risk factors that affect the neurocognitive function of BD patients. Delayed diagnosis of BD is so common that a lot of patients receive long-term antidepressant treatment before of diagnosis of unipolar depression. There is controversy about whether antidepressant treatment in early stage would affect the neurocognitive function of BD patients. In view of the high prevalence of delayed diagnosis and the use of antidepressants, it is of great scientific significance and clinical value to clarify this matter and other factors that may potentially affect the neurocognitive function of BD patients.
Read the detailed description
Subjects will not be engaged with any interventions in this study. Two senior psychiatrists are in attendance of screening the patients with the inclusion/exclusion criteria, and then all patients who meet both criteria and are willing to participate in this study will sign the informed consent before enrollment. The participants will be divided into AT or NT group according to their history of antidepressant treatment in early stage, which is done by the two senior psychiatrists. Then these senior psychiatrists will also collect additional study parameters, such as age, sex, nation, age of onset, and score of Premorbid Adjustment Scale (PAS). Furthermore, the information about history of treatments and diagnosis will be further confirmed with medical documentary and patients' guardians. Afterwards, other investigators will finish the rating work of the rest of scales. The whole procedure should be done within 180 min. Finally, ten milliliters of venous blood are adopted for measuring NSE
- Conditions
- Bipolar Disorder, Cognition
- Keywords
- antidepressant treatment, euthymic state, neurocognitive function, bipolar depression
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| antidepressant treatment group | participants who had received systemic antidepressant (consecutive treatment with adequate antidepressants for 6 weeks at least)treatment in the early stage (from initial depressive onset to first manic/hypomani episode). | |
| non-antidepressant treatment group | participants who had not received systemic antidepressant (consecutive treatment with adequate antidepressants for 6 weeks at least)treatment in the early stage (from initial depressive onset to first manic/hypomani episode). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective cognitive measures
cognitive complaints in Bipolar Disorder Rating Assessment (COBRA)
Measured: before 11AM
Objective cognitive measures
the Stroop Color and Word Test (SCWT), the categorical verbal fluency test (CVFT) (animal naming), and the Trail Making Test Part B (TMT-B), the Digital Span Forward and Backward subtest (DSFB) and the Digit Symbol Coding subtest (DSC) of the Wechsler Adult Intelligence Scale-Revised by China (WAIS-RC) and Trail Making Test Part A (TMT-A), the Visual Reproduction subtest (VRP) and the Visual Recognition subtest (VRC) of the Wechsler Memory Scale-Revised (WMS-R)
Measured: before 11AM
Secondary outcomes (3)
Global Assessment Function (GAF)
to assess patients' functions psychologically, socially and professionally
Measured: before 11AM
Methods Checklist on Quality of Life issued by World Health Organization-Brief version,WHOQOL-BRIEF
to assess the quality of life
Measured: before 11AM
Peripheral neuron-specific enolase (NSE)
to test the potential injury of neuron
Measured: before 11.30AM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chenghao Yang, Doctor, Principal investigator, Tianjin Anding Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564573
- Sponsor's protocol ID
- TJAH2020-18
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2020
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Request based on researcher's consent
Publications
Yang H, Liu Y, Yang C, Lin X. The effect of systemic antidepressant treatments in early stage on neurocognitive function of euthymic bipolar patients initiated with a depressive onset: An observational, cross-sectional, single-blind study protocol. Brain Behav. 2021 Oct;11(10):e2360. doi: 10.1002/brb3.2360. Epub 2021 Sep 14.
PubMed 34520638
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Systemic Antidepressant Treatments in Early Stage on Neurocognitive Function of Euthymic Patients With Bipolar Depression
- ClinicalTrials.gov ID
- NCT04564573
- Acronym / sponsor ID
- TJAH2020-18
- Conditions
- Bipolar Disorder, Cognition
- Keywords
- antidepressant treatment, euthymic state, neurocognitive function, bipolar depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 25 Sep 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.
Patients with bipolar disorder (BD) have a wide range of neurocognitive dysfunction, which lead to impaired psychosocial function and reduced quality of life. Therefore, improving neurocognitive function has become an important goal of BD treatment. Aiming at this, some clinical studies have been performed but failed to illustrate significant positive efficacies of pharmacological therapy or non-pharmacological therapy, which could attribute in part to insufficient understanding on the risk factors that affect the neurocognitive function of BD patients. Delayed diagnosis of BD is so common that a lot of patients receive long-term antidepressant treatment before of diagnosis of unipolar depression. There is controversy about whether antidepressant treatment in early stage would affect the neurocognitive function of BD patients. In view of the high prevalence of delayed diagnosis and the use of antidepressants, it is of great scientific significance and clinical value to clarify this matter and other factors that may potentially affect the neurocognitive function of BD patients.
Detailed description
Subjects will not be engaged with any interventions in this study. Two senior psychiatrists are in attendance of screening the patients with the inclusion/exclusion criteria, and then all patients who meet both criteria and are willing to participate in this study will sign the informed consent before enrollment. The participants will be divided into AT or NT group according to their history of antidepressant treatment in early stage, which is done by the two senior psychiatrists. Then these senior psychiatrists will also collect additional study parameters, such as age, sex, nation, age of onset, and score of Premorbid Adjustment Scale (PAS). Furthermore, the information about history of treatments and diagnosis will be further confirmed with medical documentary and patients' guardians. Afterwards, other investigators will finish the rating work of the rest of scales. The whole procedure should be done within 180 min. Finally, ten milliliters of venous blood are adopted for measuring NSE
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antidepressant treatment group | – | –participants who had received systemic antidepressant (consecutive treatment with adequate antidepressants for 6 weeks at least)treatment in the early stage (from initial depressive onset to first manic/hypomani episode). |
| non-antidepressant treatment group | – | –participants who had not received systemic antidepressant (consecutive treatment with adequate antidepressants for 6 weeks at least)treatment in the early stage (from initial depressive onset to first manic/hypomani episode). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- This study will consist of a sample of 124 patients with bipolar disorder who initiated with a depressive episode and being a euthymic state for 4 weeks at least before enrollment.All participants are divided into two groups according to whether they had received systemic antidepressant treatment or not in the early stage.
Key inclusion criteria (5 listed)
- A diagnosis of BD diagnosed according to the Diagnostic and Statistical Manual of Mental disorders, Fourth Edition (DSM-IV-TR) diagnosed with Structured Clinical Interview for DSM-IV (SCID); a current state of euthymia is defined by both scores of Montgomery-Åsberg Depression Scale (MADRS) and Young Manic Rating Scale (YMRS) <7, lasting for 4 weeks at least before recruitment
- Initiated with a depressive episode
- Aged between 18~50 years
- Patients comply with all procedures of study
- Participants must sign the informed consent
Key exclusion criteria (9 listed)
- A history of psychiatric symptoms
- A comorbidity of attention deficit and hyperactivity disorder (ADHD)
- Neurological trauma or neurological diseases which could cause cognition injury
- History of substance dependence/abuse
- Received modified electroconvulsive therapy (MECT) in the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective cognitive measures
Time frame: before 11AM
cognitive complaints in Bipolar Disorder Rating Assessment (COBRA)
Objective cognitive measures
Time frame: before 11AM
the Stroop Color and Word Test (SCWT), the categorical verbal fluency test (CVFT) (animal naming), and the Trail Making Test Part B (TMT-B), the Digital Span Forward and Backward subtest (DSFB) and the Digit Symbol Coding subtest (DSC) of the Wechsler Adult Intelligence Scale-Revised by China (WAIS-RC) and Trail Making Test Part A (TMT-A), the Visual Reproduction subtest (VRP) and the Visual Recognition subtest (VRC) of the Wechsler Memory Scale-Revised (WMS-R)
3 secondary outcomes
Global Assessment Function (GAF)
Time frame: before 11AM
Methods Checklist on Quality of Life issued by World Health Organization-Brief version,WHOQOL-BRIEF
Time frame: before 11AM
Peripheral neuron-specific enolase (NSE)
Time frame: before 11.30AM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Derived from this study: PubMed 34520638Yang H, Liu Y, Yang C, Lin X. The effect of systemic antidepressant treatments in early stage on neurocognitive function of euthymic bipolar patients initiated with a depressive onset: An observational, cross-sectional, single-blind study protocol. Brain Behav. 2021 Oct;11(10):e2360. doi: 10.1002/brb3.2360. Epub 2021 Sep 14.
- Individual participant dataSharing planned: Yes. Request based on researcher's consent
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
Chenghao Yang, Doctor principal investigator
Tianjin Anding Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Cognition, run by Tianjin Anding Hospital 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 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: status not confirmed, as of the sponsor's last update on 13 Dec 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.
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 Chenghao Yang, Doctor (+86 13752539531, yts83420@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective cognitive measures (time frame: before 11AM). 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 NCT04564573, which also lists 1 linked publication.
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 13 Dec 2021.