Depressive Disorder, Major Clinical Trial
Official title:
A Clinical Biomarker Study of Immunological Phenotypes Associated With Monoaminergic Anti-depressant Response, and the Brain and Cognitive Phenotypes Associated With Variation in Peripheral C-reactive Protein (CRP) Levels, in Patients With Major Depressive Disorder (MDD).
This is a study to characterise the role of inflammatory processes in depression. There is compelling evidence that inflammation is often associated with, and can cause, depression. It is currently less clear that antiinflammatory drugs have meaningful antidepressant effect. One of the goals is to identify the subset of depressed patients that is most likely to respond better to an antiinflammatory drug than to a conventional antidepressant. The investigators will therefore undertake a study of patients with a diagnosis of major depressive disorder including four groups: i) incompletely responsive patients who have demonstrated failure to respond consistently or completely to standard treatment, ii) those who have responded well to treatment and are not currently depressed, iii) untreated patients who are currently depressed, iv) healthy volunteers with no history of depression. Participants will undergo a clinical assessment, an interview with a trained member of the research team and will complete self-rated questionnaires. Investigators will collect blood and saliva samples to measure certain immune markers. They will also perform magnetic resonance imaging (MRI) scans to look for MRI markers in the brain and investigate brain inflammation in a subsample of these patients using positron emission topography (PET) and cerebrospinal fluid (CSF) sampling (also called lumbar puncture).
The hypotheses are (i) that therapeutic resistance to monoaminergic (MA) antidepressant drugs
is associated with peripheral biomarkers indicating abnormal activation of the innate immune
system; and (ii) that peripheral inflammation, defined by blood levels of C-reactive protein
(CRP), is associated with central nervous system inflammation and abnormal brain structure
and function.
The objectives are to test these two hypotheses by collecting clinical, immunological and
neuroimaging data on patients with depression (DEP+) recruited from a network of clinical
research sites in the United Kingdom.
Primary objective:
To measure peripheral immunophenotypes in healthy volunteers (at least N=50) and 3 groups of
depressed patients, categorised by their exposure and therapeutic response to monoaminergic
antidepressants (up to N=200):
- Incompletely responsive patients (approximately N ~100) who are currently depressed
after greater than 6 weeks of treatment with one or more monoaminergic antidepressants
(DEP+MA+);
- Responsive patients (approximately N~50) who are not currently depressed after greater
than 6 weeks of treatment with a monoaminergic antidepressant (DEP-MA+);
- Untreated patients (approximately N~50) who are currently depressed but have not been
treated with monoaminergic antidepressants in the previous 6 weeks (DEP+MA-);
- Healthy volunteers (approximately N~50) who have no personal history of depression
requiring treatment with either monoaminergic antidepressants or other clinical
interventions including psychotherapy (DEP-MA-).
Secondary objective:
To measure brain and cognitive phenotypes in a subsample of up to N=100 depressed patients
recruited, preferably from the primary cohort, on the basis of their CRP levels:
- Low CRP patients (N~45) will have CRP <= 3 mg/L
- High CRP patients (N~45) will have CRP > 3 mg/L
- Healthy volunteers (at least N=45).
All subjects in this sample will be assessed using structural and functional magnetic
resonance imaging (MRI) and subjects providing additional specific consents will also be
assessed using positron emission tomography (PET-MR), and/or lumbar puncture (LP) for
cerebrospinal fluid (CSF) sampling.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05915013 -
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
|
Phase 1 | |
Completed |
NCT04469322 -
Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression
|
N/A | |
Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
Recruiting |
NCT05988333 -
Psychoeducational Intervention for Families With a Member Affected by Major Depression
|
N/A | |
Completed |
NCT02919501 -
Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder
|
Phase 2 | |
Completed |
NCT00976560 -
Clinical Study to Test a New Drug to Treat Major Depression
|
Phase 2 | |
Recruiting |
NCT05518149 -
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
|
Phase 3 | |
Not yet recruiting |
NCT06303076 -
Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial
|
Phase 4 | |
Not yet recruiting |
NCT05901571 -
Acupuncture and Escitalopram for Treating Major Depression Clinical Study
|
N/A | |
Completed |
NCT02452892 -
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
|
N/A | |
Suspended |
NCT02546024 -
Predictors of Treatment Response in Late-onset Major Depressive Disorder
|
N/A | |
Completed |
NCT01407575 -
Buprenorphine for Treatment Resistant Depression
|
Phase 3 | |
Completed |
NCT01583400 -
Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial
|
N/A | |
Completed |
NCT01152996 -
Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study
|
Phase 3 | |
Enrolling by invitation |
NCT00762866 -
Psychiatric Genotype/Phenotype Project Repository
|
||
Completed |
NCT00384033 -
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT00369343 -
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
|
Phase 3 | |
Completed |
NCT00366652 -
Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
|
Phase 3 | |
Completed |
NCT00149643 -
Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence
|
Phase 2 | |
Completed |
NCT00316160 -
Sexual Functioning Study With Antidepressants
|
Phase 4 |