- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02389465
Stress and Inflammation in Late-Life Depression (S&I)
Stress and Inflammation in the Pathophysiology of Late Life Depression
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-80, male or female, any race;
- Absence of clinical dementia
- English speaking
- Blood pressure not exceeding 150/90 mmHg, treated or untreated
- Weight greater than 110 lbs
- Normal result on liver-function test
- No history of ulcer disease or GI bleeding
- No renal insufficiency
Additional Inclusion Criteria for Depressed Participants:
- DSM-IV criteria for Major Depressive Disorder
- HAM-D greater than 18
Exclusion Criteria:
- Known history of relevant severe drug allergy or hypersensitivity (e.g. to Citalopram or Escitalopram, and/or to celecoxib, aspirin, or other NSAIDs only for Phase 2; known demonstration of allergic-type reactions to sulfonamides);
- Does not speak English;
- Cannot give informed consent;
- MRI contraindications (e.g., foreign metallic implants, pacemaker);
- Known primary neurological disorders, such as Parkinson's disease, Alzheimer's disease, traumatic brain injury, cognitive impairment or dementia,
- Known severe inflammatory disease such as systemic lupus erythematosis, known autoimmune diseases, such as multiple sclerosis, rheumatoid arthritis; Screen + for RF, ANA, HIV, Hepatitis B or C.
- Clinical Dementia Rating Scale score greater than 0;
- Diagnosis of a chronic psychiatric illness other than MDD at the discretion of the study doctor;
- Significant handicaps (e.g. uncorrected hearing or visual impairment, mental retardation) that would interfere with testing;
- Bleeding diathesis;
- Severe Medical problem, which in the opinion of the investigator would pose a safety risk to the subject;
- Clinically significant cardiovascular disease that will be assessed on a case-by-case basis. Clinically significant cardiovascular disease usually includes one or more of the following: cardiac surgery or myocardial infarction within the last 4 weeks; unstable angina; acute decompensated congestive heart failure or class IV heart failure; current significant cardiac arrhythmia or conduction disturbance, particularly those resulting in ventricular fibrillation, or causing syncope or near syncope; uncontrolled high blood pressure; QTc greater than 450msec (by history for subjects with cardiac disease); documented prior stroke;
- Clinically significant abnormalities on EKG. Primary AV block or Right bundle branch block are not necessarily exclusionary;
- Current diagnosis of cancer
- Current diagnosis of HIV, active Hepatitis B and/or Hepatitis C
- Use of an Investigational medicine within the past 30 days;
- Use of Coumadin, Warfarin within the past 2 months;
- Current treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers, mood stabilizers, antipsychotics, steroids or non-steroidal anti-inflammatory medications or other antidepressants. No subjects will be included in the study unless they have been off all psychotropics for at least 3 weeks, except in the case of fluoxetine, where 5 weeks off treatment will be required;
- Current alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, or current OCD;
- Abnormal liver-function test
- History of ulcer disease, Chron's disease, GI bleeding or anemia
- Weight less than 110 lbs
- Renal insufficiency
- Any other factor that in the investigator's judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from this facility);
Additional Exclusion Criteria for Depressed Subjects:
1) Active suicidality or current suicidal risk as determined by the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
This arm is for participants who are not depressed.
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Experimental: Experimental - treatment
Depressed participants will receive an antidepressant (escitalopram) AND either a non-steroidal anti-inflammatory drug (celecoxib) OR placebo (sugar pill) for 6 weeks.
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Participants will receive celecoxib in addition to escitalopram
Participants will receive a placebo in addition to escitalopram.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IL-6 Levels
Time Frame: up to week 6
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IL6 levels were measured in participants by blood draw 6 weeks after the first dose was given.
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up to week 6
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Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: Week 6
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This depression rating scale will be used to determine clinical outcome for depressed participants. Scores range from 0-60. The higher the score, the worse the outcome (see below) Normal: 0-6 Mild Depression: 7-19 Moderate Depression: 20-34 Severe Depression: 35+ Very Severe Depression: 60 |
Week 6
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IL10 Levels
Time Frame: up to 6 weeks
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IL10 levels were measured in participants by blood draw 6 weeks after the first dose was given
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up to 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yvette Sheline, University of Pennsylvania
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Inflammation
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Cyclooxygenase 2 Inhibitors
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Selective Serotonin Reuptake Inhibitors
- Citalopram
- Celecoxib
- Dexetimide
- Escitalopram
Other Study ID Numbers
- 5R01MH098260-02 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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