depression
Conditions
Interventions
Healthy Control Group(Study Part I):None
Depression Group(Study Part I):Routine Drugs Treatment
Research Group(Study Part II):SSRI combine with acipimox treatment
Control Group(Study Part II):None
Sponsors
Beijing Anding Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Study Part I: (1).Depression Group: 1) age range: 18 to 60; 2) DSM-5 standard diagnosis of depression; 3) total score of >= 17 points on Hamilton Depression Score (HAMD-17) at baseline; 4) antidepressant therapy not received during the 2 weeks prior to baseline; 5) MECT/rTMS therapy not received within the 4 weeks prior to baseline; 6) has adequate visual and understanding capabilities; 7) informed consent signed by the subjects. (2).Healthy Control Group: 1) age range: 18 to 60; regardless of gender; 2) no history of psychiatric illness; 3) no previous use of psychotropic drugs; 4) have an education level of at least primary school and be capable of understanding the content of the study; 5) informed consent signed by the subjects. 2.Study Part II: 1) age range: 18 to 60; 2) DSM-5 standard diagnosis of depression; 3) total score of >= 17 points on Hamilton Depression Score (HAMD-17) at baseline; 4) NSFT response index at baseline of <=6920.5, suggesting a moderate or greater risk; 5) antidepressant therapy not received during the 2 weeks prior to baseline; 6) MECT/rTMS therapy not received within the 4 weeks prior to baseline; 7) planning to receive SSRI therapy; 8) has adequate visual and understanding capabilities; 9) informed consent signed by the subjects.
Exclusion criteria
Exclusion criteria: 1.Study Part I: (1).Depression Group:1) Current or previous significant diagnoses consistent with DSM-5 other than depressive disorders including schizophrenia, schizoaffective disorder, bipolar disorder, neurodevelopmental disorders, and neurocognitive disorders; 2) Patients with a previous history of alcohol or psychoactive drug dependence; 3) Patients taking immunosuppressants, anti-inflammatory drugs, or multivitamin supplements; 4) Female patients who are nursing or pregnant; 5) Currently having serious or unstable physical illness; 6) Individuals with forearm skin injuries or diseases; 7) Individuals with a severe allergic constitution. (2).Healthy Control Group: 1) Individuals with psychiatric illness within two or three generations; 2) Individuals with history of disorders of consciousness; 3) Family history of genetic disorders; 4) Individuals with significant physical illnesses; 5) History of alcohol or drug abuse; 6) Individuals with an history of alcohol or drug abuse; 7) Pregnant or breastfeeding women; 8) Individuals with forearm skin injuries or diseases; 9) Individuals with a severe allergic constitution. Study Part II: 1) Current or previous significant diagnoses consistent with DSM-5 other than depressive disorders including schizophrenia, schizoaffective disorder, bipolar disorder, neurodevelopmental disorders, and neurocognitive disorders; 2) Patients with a previous history of alcohol or psychoactive drug dependence; 3) Presence of severe self-injury, suicidal ideation or behavior with a HAMD-17 scale item 3 >= 3 points; 4) Current serious or unstable physical illness, or clinically significant abnormalities in laboratory tests or functional tests in the judgment of the investigator; 5) Patients with refractory depression (those who have taken two antidepressant medications with different mechanisms of action for the current episode and who have not responded to the full dosage and course of treatment); 6) Patients with a history of allergy to nicotinic acid-based preparations; 7) Patients taking immunosuppressants, anti-inflammatory drugs, statins or fibrates, and multivitamin supplements; 8) Patients who have received an investigational drug or used an invasive investigational medical device within 3 months prior to the first dose of the investigational drug, or are expected to participate in another clinical interventional trial up to the primary endpoint; 9) Pregnant or breastfeeding women; 10) Individuals with forearm skin injuries or diseases; 11) Individuals with a severe allergic constitution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NSFR scores(Study Part I);17-item Hamilton Depression Scale Scores(8 week minus baseline)(Study Part II); | — |
Secondary
| Measure | Time frame |
|---|---|
| 17-item Hamilton Depression Scale (HAMD-17) (Study Part I);Inventory for Depressive Symptomatology,Self-Report(IDS-SR30)(Study Part I);Inventory for Depressive Symptomatology,Clinician Rated(IDS-C30)(Study Part I);NSFR scores(Study Part II);Inventory for Depressive Symptomatology,Self-Report Scores (4 and 8 week minus baseline)(Study Part II);Inventory for Depressive Symptomatology,Clinician Rated Scores (4 and 8 week minus baseline)(Study Part II);Blood Lipid Level(Study Part II);Uric Acid Level(Study Part II);Medication Adherence Assessment(Study Part II);17-item Hamilton Depression Scale Scores(4 week minus baseline)(Study Part II); | — |
Countries
China
Contacts
Public ContactLing Zhang
Beijing Anding Hospital,Capital Medical University
Outcome results
None listed