Clinical trial NCT04564573: Antidepressant Treatments and Cognitive Function of Bipolar Patients
Official title: The Impact of Systemic Antidepressant Treatments in Early Stage on Neurocognitive Function of Euthymic Patients With Bipolar Depression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder
Cognition
Keywords: antidepressant treatment
euthymic state
neurocognitive function
bipolar depression
Lead sponsor: Tianjin Anding Hospital
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Subjective cognitive measures
timeFrame: before 11AM
measure: Objective cognitive measures
timeFrame: before 11AM
Secondary outcomes:
measure: Global Assessment Function (GAF)
timeFrame: before 11AM
measure: Methods Checklist on Quality of Life issued by World Health Organization-Brief version,WHOQOL-BRIEF
timeFrame: before 11AM
measure: Peripheral neuron-specific enolase (NSE)
timeFrame: before 11.30AM
Other outcomes:
measure: Pittsburgh Sleep Quality Index,PSQI
timeFrame: before 11AM
measure: Positive and Negative Affect Scale,PANAS
timeFrame: before 11AM
Locations:
city: Tianjin
country: China
facility: Tianjin Anding Hospital
Study officials:
affiliation: Tianjin Anding Hospital
name: Chenghao Yang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.