Antidepressant Treatments and Cognitive Function of Bipolar Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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The Impact of Systemic Antidepressant Treatments in Early Stage on Neurocognitive Function of Euthymic Patients With Bipolar Depression

Conditions
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Bipolar Disorder, Cognition

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Recent drug use that affects cognition, such as tricyclic antidepressants, anticholinergic drugs, amphetamines, etc. IQ <70 Use benzodiazepines 4 hours before scale evaluation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| antidepressant treatment group<br>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<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | to assess the quality of life | before 11AM | 
| Peripheral neuron-specific enolase (NSE) | to test the potential injury of neuron | before 11.30AM | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antidepressant treatment, euthymic state, neurocognitive function, bipolar depression