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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 : September 27, 2017
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 depression, 400 patients with bipolar depression, and 400 healthy controls.

Condition or disease Intervention/treatment Phase
Affective Disorder Drug: Lithium Carbonate Oral Tablet Drug: Escitalopram Pill Not Applicable

Detailed Description:

Four hundred patients with a primary diagnosis of depression and HAMD-17 scores ≥18 at baseline visit are to be assigned to one of the second-generation antidepressant drugs. 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, during which they receive combination therapy with aripiprazole. The clinical assessment (HAMD/CGI/PANAS/subtypes of depression), 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, 100 receive MRI scans.

Four hundred patients with a primary diagnosis of bipolar disorder and HAMD-17 scores≥18 at baseline visit are to be assigned to mood stabilizers or a combination of mood stabilizers and SSRI antidepressants for 8 weeks. The clinical assessment (HAMD/CGI/PANAS), early life stress, neuropsychological test, and biological examination (MRI, genetics, neurochemistry, and immunology) were conducted to identify biomarker associated with diagnosis, treatment efficacy prediction of bipolar depression. Among the 400 patients, 100 receive MRI scans.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Psychopharmacology Division
Actual Study Start Date : January 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2019


Arm Intervention/treatment
Experimental: Lithium carbonate
Lithium Carbonate oral tablet, 500mg~2000mg/day, oral,8weeks
Drug: Lithium Carbonate Oral Tablet
lithium carbonate 500mg~2000mg/day

Active Comparator: lithium carbonate+escitalopram
a combination of lithium carbonate oral tablet and escitalopram pill
Drug: Lithium Carbonate Oral Tablet
lithium carbonate 500mg~2000mg/day

Drug: Escitalopram Pill
escitalopram 10~20mg/day




Primary Outcome Measures :
  1. reduction in HAMD total scores [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 first depressive episode
    • Total HAMD-17 score≥18 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.
  2. Bipolar depression

    • The inclusion criteria for bipolar depression patients were: male or female outpatients aged between 18 and 55 years old
    • Currently in depressive episode
    • Total HAMD-17 score≥18 at baseline visit.
    • The diagnosis of bipolar disorder was confirmed by a trained psychiatrists using 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
Contact: Li Wang, PhD 010-62723742 wleewell@qq.com

Locations
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
Principal Investigator: Tianmei Si, PhD Sixth hospital of beijing university

Responsible Party: Si Tianmei, Clinical Psychopharmacology Division, Peking University
ClinicalTrials.gov Identifier: NCT03294525     History of Changes
Other Study ID Numbers: 001
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders
Citalopram
Lithium Carbonate
Dexetimide
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
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Enzyme Inhibitors
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants