Antidepressant Treatments and Cognitive Function of Bipolar Patients

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04564573
• Other study ID #: TJAH2020-18
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: September 2021
• Source: Tianjin Anding Hospital
• Contact: Chenghao Yang, Doctor
• Phone: +86 13752539531
• Email: yts83420[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: October 30, 2022
• Est. primary completion date: July 1, 2022
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. 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

2. Initiated with a depressive episode

3. Aged between 18~50 years

4. Patients comply with all procedures of study

5. Participants must sign the informed consent

Exclusion Criteria:

1. A history of psychiatric symptoms

2. A comorbidity of attention deficit and hyperactivity disorder (ADHD)

3. Neurological trauma or neurological diseases which could cause cognition injury

4. History of substance dependence/abuse

5. Received modified electroconvulsive therapy (MECT) in the past 12 months

6. Severe physical disease affecting cognitive function or increasing peripheral NSE

7. Recent drug use that affects cognition, such as tricyclic antidepressants, anticholinergic drugs, amphetamines, etc.

8. IQ <70

9. Use benzodiazepines 4 hours before scale evaluation

Related Conditions & MeSH terms

• Bipolar Disorder
• Cognition

Locations

Country	Name	City	State
China	Tianjin Anding Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Anding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pittsburgh Sleep Quality Index,PSQI	to evaluate the quality of sleep	before 11AM
Other	Positive and Negative Affect Scale,PANAS	to detect the change in positive and negative affect	before 11AM
Primary	Subjective cognitive measures	cognitive complaints in Bipolar Disorder Rating Assessment (COBRA)	before 11AM
Primary	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	Global Assessment Function (GAF)	to assess patients' functions psychologically, socially and professionally	before 11AM
Secondary	Methods Checklist on Quality of Life issued by World Health Organization-Brief version,WHOQOL-BRIEF	to assess the quality of life	before 11AM
Secondary	Peripheral neuron-specific enolase (NSE)	to test the potential injury of neuron	before 11.30AM