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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective cognitive measures | cognitive complaints in Bipolar Disorder Rating Assessment (COBRA) | 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) | before 11AM |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment Function (GAF) | to assess patients' functions psychologically, socially and professionally | before 11AM |
| Methods Checklist on Quality of Life issued by World Health Organization-Brief version,WHOQOL-BRIEF |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index,PSQI | to evaluate the quality of sleep | before 11AM |
| Positive and Negative Affect Scale,PANAS | to detect the change in positive and negative affect |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenghao Yang, Doctor | Contact | +86 13752539531 | yts83420@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chenghao Yang, Doctor | Tianjin Anding Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Anding Hospital | Recruiting | Tianjin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34520638 | Derived | 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. |
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Request based on researcher's consent
the data will be available openly after the study finished with no termination.
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Ten milliliters of venous blood are adopted from each participant into a free-anticoagulant vacuum tube. The blood will be immediately centrifuged at 4,000 g for 10 min, and serum is kept frozen at -80 ÂșC until analysis. NSE levels are measured with electrochemiluminescence assay, using a commercial kit conforming to the manufacturer instructions and data will be shown in ng/ml.
to assess the quality of life
| before 11AM |
| Peripheral neuron-specific enolase (NSE) | to test the potential injury of neuron | before 11.30AM |
| before 11AM |