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Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders

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ClinicalTrials.gov Identifier: NCT03294525
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Si Tianmei, Peking University

Brief Summary:
The project is a multi-center, prospective cohort study. The study's total targeted enrollment is 400 first-episode patients with major depressive disorder (MDD) and 400 healthy controls.

Condition or disease Intervention/treatment
Affective Disorder Drug: Escitalopram Pill Drug: Duloxetine Drug: Mirtazapine Pill Drug: Other Antidepressants

Detailed Description:
Four hundred patients with a primary diagnosis of depression and HAMD-17 scores ≥17 at baseline visit are to be assigned to one of the second-generation antidepressant drugs, including escitalopram, duloxetine, mirtazapine, paroxetine, sertraline, etc based on investigators' clinical practice. Initial treatment consists of a 8-week course with one of these monotherapies. Patients who meet criteria for full remission are followed for a 22-month follow-up phase to monitor for depression recurrence. Patients who do not remit are offered another 8 weeks of acute treatment, including combination therapy or switching to other antidepressant based on investigators' clinical practice. The clinical assessment (Hamilton Depression Rating Scale(HAMD)/ Clinical general impression (CGI) /the Positive and Negative Affect Schedule (PANAS) /subtypes of depression, Dimensional Anhedonia Rating Scale (DARS) , etc), early life stress, neuropsychological test, and biological examination (MRI, genetics, neurochemistry, and immunology) were conducted to identify the biomarkers associated with diagnosis, treatment efficacy prediction of depression. Among the 400 patients, about 100 patients receive MRI scans at baseline and after treatment.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Psychopharmacology Division
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders

Group/Cohort Intervention/treatment
Escitalopram-for MDD
Eligible patients were assigned to escitalopram treatment based on investigators' clinical practice.
Drug: Escitalopram Pill
escitalopram 10~20mg/day
Other Name: Lexapro

Duloxetine-for MDD
Eligible patients were assigned to duloxetine treatment based on investigators' clinical practice.
Drug: Duloxetine
duloxetine 30~120mg/day
Other Name: Cymbalta

Mirtazepine-for MDD
Eligible patients were assigned to mirtazepine treatment based on investigators' clinical practice.
Drug: Mirtazapine Pill
Mirtazapine 15~45mg/day
Other Name: Remeron

other antidepressant-for MDD
Eligible patients were assigned to other antidepressant treatment (including sertraline, paroxetine, fluoxetine, venlafaxine, etc) based on investigators' clinical practice.
Drug: Other Antidepressants



Primary Outcome Measures :
  1. reduction in HAMD total scores [ Time Frame: 8 weeks ]
    reduction more than 50% was regarded as response

  2. remision [ Time Frame: 8 weeks ]
    HAMD total score less than 7


Biospecimen Retention:   Samples With DNA
Blood samples were collected by venepuncture.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with major depressive disorder
Criteria

Inclusion Criteria:

1. Patients with depression

  • The inclusion criteria for depressed patients were: male or female outpatients aged between 18 and 55 years old
  • Currently in acute depressive episode
  • Total HAMD-17 score≥17 at baseline visit.
  • The diagnosis of depression was confirmed by a trained psychiatrists using the Mini-International Neuropsychiatric Interview (MINI).
  • The patients participating in imaging scans should additionally satisfy: not taking psychiatric drugs within last two weeks (except for benzodiazepine) or fluoxetine last one month
  • Not receiving ECT within last 6 months.

Exclusion Criteria:

  • Unable to complete the questionnaire and psychological assessment independently
  • Significant cognitive impairments determined by system mental examination and inability to sign an informed consent form
  • Past or presently suffering from other psychiatric disorders, alcohol and drug dependence
  • Suffering from major physical diseases, such as cardiovascular and cerebrovascular diseases, respiratory diseases, kidney disease, cancer and so on; personality disorder
  • Intellectual disabilities
  • Suicidal behavior
  • Being participating in other studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294525


Contacts
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Contact: Yunai Su, PhD 010-62723761 suyunai@163.com

Locations
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China, Beijing
Institute of mental health, Peking University Recruiting
Beijing, Beijing, China, 100191
Contact: Tianmei Si, PhD.    8610-82801960    si.tian-mei@163.com   
Principal Investigator: Tianmei Si, PhD.         
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Tianmei Si, PhD Sixth hospital of beijing university
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Responsible Party: Si Tianmei, Clinical Psychopharmacology Division, Peking University
ClinicalTrials.gov Identifier: NCT03294525    
Other Study ID Numbers: 001
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Mirtazapine
Citalopram
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Psychotropic Drugs
Peripheral Nervous System Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Analgesics
Sensory System Agents
Dopamine Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents