Major Depressive Disorder Clinical Trial
Official title:
Biomarkers of Neuroinflammation and Anti-Inflammatory Treatments in Major Depressive Disorder
Verified date | May 2019 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if translocator protein total distribution volume (TSPO VT) is elevated in major depressive disorder that is not responding to medication and if adding minocycline can affect TSPO VT. Many remain treatment resistant with common antidepressant treatments and the investigators think it may be due to poor targeting of brain pathologies.
Status | Completed |
Enrollment | 115 |
Est. completion date | April 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Group 1 - Current major depressive episode (MDE) secondary to MDD Inclusion Criteria: - good physical health with no active medical conditions - non-cigarette smoking - no past or current substance abuse or dependence - negative urine pregnancy test at screening and scan days (for women) - primary diagnosis of current major depressive episode (MDE) and major depressive disorder (MDD) verified by SCID for DSM IV - score greater than 19 on the 17 item HDRS - non-response to a clinical trial of at least one antidepressant given at appropriate clinical dose - willing to take medication for the duration of the trial and has previously taken antidepressants for the duration of the trial - presently taking an antidepressant at a standard clinical dose. Exclusion Criteria: - history of neurological illness or autoimmune disorders - never taken a tricyclic antidepressant or an antidepressant that raises norepinephrine - received treatment with electroconvulsive therapy or mechanical brain stimulation in the previous 6 months - currently taking medication contraindicated or that may possibly interact with either minocycline or celecoxib - known intolerance or allergy to minocycline, other tetracyclines, sulfonamides or NSAIDs - taken diazepam or other benzodiazepine use within the past month, except for lorazepam and clonazepam - use of anti-inflammatory drugs or tetracyclines lasting =1 week within the past month - history of severe hepatic or renal insufficiency, asthma, allergies, gastrointestinal disease, ischemic heart disease, cerebrovascular disease or congestive heart failure - lactose intolerance Group 2 - Healthy Controls - Phase 1 (baseline scan) only Inclusion criteria: - score below 8 on the 17 item HDRS - good physical health - non-cigarette smoking - negative urine pregnancy test at screening and scan days (for women) - negative urine screen for drugs of abuse Exclusion criteria: - past or current diagnosis of axis I or axis II disorder as determined by the SCID I and SCID II for DSM IV - history of psychotropic medication use - history of neurological illness or autoimmune disorder |
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hopkins Verbal Learning Test-Revised | To assess verbal memory we will administer the Hopkins Verbal Learning Test-Revised to MDE participants before and after treatment. | Pre- and post-minocycline or placebo treatment (8 weeks between pre- and post-treatment measure) | |
Other | Brief Visuospatial Memory Test-Revised | To assess visuospatial memory we will administer the Brief Visuospatial Memory Test-Revised to MDE participants before and after treatment. | Pre- and post-minocycline or placebo treatment (8 weeks between pre- and post-treatment measure) | |
Other | Comprehensive Trails Making Test | To assess psychomotor speed and attention we will administer the Comprehensive Trails Making Test to MDE participants before and after treatment. | Pre- and post-minocycline or placebo treatment. | |
Other | Genetic sample | The priority of the genetic sample is to analyze the alleles of polymorphism rs6971 which has an association with the affinity of most second generation TSPO ligands including [18F]FEPPA. The genetic sample will also be used to study sequences of genes that are believed to affect TSPO expression, inflammation, mood and conditions that may predispose to mood disorders. | Phase 1-single sample | |
Other | Blood samples (serum and plasma) | Analyses will include complete blood cell count (CBC), ESR, hepatic and renal function. Peripheral marker analyses will include proteins related to TSPO expression and inflammation. Plasma minocycline and celecoxib levels will be analyzed. | Pre- and post-minocycline or placebo treatment (8 weeks between measures). Pre- and post-celecoxib treatment (8 weeks between measures). | |
Primary | Translocator total distribution volume (TSPO VT): Treatment Effect of Minocycline in MDE Subjects | TSPO VT will be measured using [18F]FEPPA positron emission tomography brain scans. Eligible MDE participants will be randomized to either minocycline or placebo. Following 8 weeks of either minocycline or placebo treatment, MDE participants will have a second PET scan . | Pre- and post-minocycline or placebo treatment= 8 weeks total between pretreatment and posttreatment scans | |
Primary | Translocator total distribution volume (TSPO VT): Difference between MDE and healthy subjects | Compare baseline TSPO VT prior to treatment between MDE group and healthy group | Pre-treatment scan will take place up to 8 weeks from initial assessment | |
Secondary | Change in Hamilton Depression Rating Scale Score | Change in HDRS score following minocycline vs. placebo treatment. Change in HDRS score following celecoxib treatment. | Pre- and post-minocycline treatment (8 weeks total between pre- and post-treatment). Pre- and post-celecoxib treatment (8 weeks total between pre- and post-treatment). |
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