Depression Clinical Trial
— IRLGreyBOfficial title:
Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine
Verified date | June 2019 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are conducting a research study to learn about the safety and benefit of using a medication called buprenorphine for patients with difficult to treat depression. This research study is testing whether combining two medications will be effective in treating depression when initial treatment with just one antidepressant does not relieve the depressive symptoms; this is what is called "difficult to treat depression" or "treatment resistant depression". The two medications the investigators are using are: an anti-depressant medication called venlafaxine extended release (venlafaxine XR), which is the generic form of Effexor, and buprenorphine. Buprenorphine is a medication that is FDA approved for the treatment of opioid dependence. The investigators are testing whether adding buprenorphine to venlafaxine XR enhances treatment response.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 30, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria for Main Study: 1. Age > or = to 50 years. 2. Major depressive disorder (MDD), single or recurrent, as diagnosed by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID-IV). 3. Montgomery Asberg Depression Rating Scale (MADRS) >/= to 15. 4. Has or agrees to establish a clinical relationship with primary care physician (PCP). 5. Availability of an informant (e.g., emergency contact). Exclusion Criteria: 1. Inability to provide informed consent. 2. Depressive symptoms not severe enough (i.e., MADRS < 15) at the baseline assessments 3. Dementia, as defined by Mini Mental State Exam (3MS) < 84 and clinical evidence of dementia (e.g., memory impairment, executive dysfunction, agnosia, apraxia, aphasia, with functional impairment). 4. Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms, as diagnosed by the SCID. 5. Abuse of or dependence on alcohol or other substances within the past 3 months as determined by SCID, and confirmed by study physician interview. 6. Drinking 15 or more drinks per week or consuming 5 or more drinks on any one occasion in the past week. 7. High risk for suicide (e.g., active SI and/or current/recent intent or plan) and unable to be managed safely in the clinical trial (e.g., unwilling to be hospitalized). Urgent psychiatric referral will be made in these cases. 8. Contraindication to venlafaxine XR or BPN as determined by PCP and study physician including history of intolerance of either venlafaxine XR or BPN in the study target dosage range (venlafaxine XR at up to 300 mg/day; BPN at up to 2 mg/day). 9. Inability to communicate in English (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in English). 10. Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview). 11. Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management. This will be determined based on information from the patient's personal physician and study physician's clinical judgment. Referral to the patient's personal physician or to a general practitioner will be made in these cases. 12. Subjects taking psychotropic medications that cannot be safely tapered and discontinued prior to study initiation. The following exceptions are allowed if they have been taken at a stable dose for at least 4 weeks prior to study entry and there is not a plan to change the dose during the next 28 weeks: benzodiazepines up to 2 mg/d lorazepam equivalent; other sedative-hypnotics (e.g., zolpidem, zaleplon, eszopiclone); gabapentin if prescribed for non-psychiatric indication (e.g., neuropathy). 13. History of opioid abuse or dependence. 14. Severe pain, defined as > 7 on 0-10 numeric rating scale for pain. 15. Concomitant use of strong or moderate CYP3A4 inhibitor (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem). 16. Refusal to stop all opioids (to avoid precipitating opioid withdrawal). 17. Hepatic impairment 18. Estimated Glomerular Filtration Rate (GFR) < 20 ml/min. 19. Inability/refusal to identify a person as an emergency contact. 20. Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Reckitt Benckiser LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery-Asberg Depression Rating Scale (MADRS) | Measure of depression severity, range of 0-60, with higher scores indicating more severe depression. We calculated the mean change in depression for both groups using baseline MADRS and week 8 MADRS scores. | Baseline and 8 weeks | |
Primary | Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) | Three item side effect scale used to assess frequency and intensity of side effects (range 0-6 for each item). We calculated the total score of all three items (range 0-18) with lower numbers indicating less frequency. We calculated the mean score at baseline and week 8 (final timepoint). |
Week 1 and week 8 | |
Primary | Antidepressant Side Effect Checklist (ASEC) | Measure of side effects, consisting of 21 items, ranging from 0-3 (0 indicates no side effect, 3 indicates severe side effect). We calculated the total final score for the 21 items (total range is 0-63). A higher total number represents a greater severity in reported side effects. We calculated the mean change in side effects for both groups using baseline and 8 week data. | Baseline and 8 weeks | |
Secondary | Suicide Ideation Scale (SIS) | A 19 item scale used to measure the presence or absence of suicidal ideations and the degree of severity of suicidal ideas. For this study, we computed the total score for all 19 items (total range 0-90). Higher scores represent a worse outcome. We also calculated the mean change in suicidal ideation for both groups using baseline and week 8 (final timepoint). | Baseline and 8 weeks | |
Secondary | Brief Symptom Inventory-Anxiety Subscale (BSI) | Measure of anxiety. Six anxiety symptoms are rated based on how distressed the subject is for each symptom. The range for each symptom is 0-4, with 4 representing extreme distress. We computed the mean of the final BSI score (range 0-24), with a lower number indicating a better outcome. We also calculated the mean change in anxiety for both groups using baseline and Phase 2 week 8 (final time point) data. | Baseline and 8 weeks | |
Secondary | Numeric Scale of Pain (NRS-P) | Measure used to assess pain, ranging from 0-10, with 10 being the worst possible pain. We calculated the mean change in pain for both groups using baseline and week 8 (last time point). |
Baseline and 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |