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Buprenorphine Used With Treatment Resistant Depression in Older Adults

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Depression

Intervention: venlafaxine XR (Drug); buprenorphine (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Not yet recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Eric J Lenze, MD, Principal Investigator, Affiliation: Washington University School of Medicine

Overall contact:
Julia Schweiger, CCRC, Phone: 314-362-3153, Email: schweigj@psychiatry.wustl.edu

Summary

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 XR (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.

Clinical Details

Official title: Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Montgomery-Asberg Depression Rating Scale (MADRS)

Frequency, Intensity, and Burden of Side Effects Rating (FIBSER)

Antidepressant Side Effect Checklist (ASEC)

Secondary outcome:

Suicide Ideation Scale (SIS)

Brief Symptom Inventory (BSI)

Numeric Scale of Pain (NRS-P)

Detailed description: We will consent approximately 100 participants, aged 50 and older, of both sexes and all races. Participation may last up to 32 weeks. We will utilize a clinical trial that has 3 Phases. In Phase 1 we will treat participants with approximately a 12 week course of open-label venlafaxine XR. This is the same lead-in treatment as in our ongoing "IRL Grey" ("Incomplete Response in Late Life Depression: Getting to Remission") multi-site R01 for late-life treatment resistant depression (LL-TRD), and we have found it to be highly successful. Participants who find relief from their depressive symptoms on venlafaxine XR alone will exit the study. Participants meeting criteria for an incomplete response (those still feeling depressed or withdrawn), will be randomly assigned to receive either low-dose buprenorphine or placebo augmentation of venlafaxine xr for 8 weeks (Phase 2), with the goal of achieving remission. At the conclusion of Phase 2, the blind will be broken for all participants. Those who are considered in remission (free of their depressive symptoms), whether on buprenorphine (BPN) or placebo, in Phase 2, they will receive continuation treatment with the same intervention to which they were randomly assigned (Phase 3 for remitters), for 8 weeks to determine the stability of remission. Non-remitters (those who did not get better) of Phase 2 who had been receiving placebo will be offered the opportunity to receive open-label buprenorphine (BPN) for 8 weeks (Phase 3 for placebo). Non-remitters of Phase 2 who had been receiving buprenorphine (BPN) will be offered the opportunity to titrate (increase) to the highest tolerated dose (if not already achieved in Phase 2) of buprenorphine (BPN) and remain in the study for an additional 8 weeks (Phase 3 for buprenorphine (BPN) non-remitters). Buprenorphine (BPN) will be tapered upon exiting the study, under the guidance of the P. I. The Phase 3 variations will allow all participants a chance to experience the benefits of buprenorphine (BPN). Efficacy and tolerability data will provide a clinically informative estimate of benefits and risks of buprenorphine augmentation for late-life treatment resistant depression (LL-TRD). We will randomize approximately 20 subjects into Phase 2. Additionally, we will collect buprenorphine (BPN) plasma levels on all those randomized to explore a dose-effect relationship on treatment response.

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age > or = to 50 years. 2. Major depressive disorder (MDD), single or recurrent, as diagnosed by the 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 3MS < 80 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. 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. 7. 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 1. 2 mg/day). 8. 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). 9. Non-correctable clinically significant sensory impairment (i. e., cannot hear well enough to cooperate with interview). 10. 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. 11. 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). 12. History of opioid abuse or dependence. 13. Severe pain, defined as > 7 on 0-10 numeric rating scale for pain. 14. Concomitant use of strong or moderate CYP3A4 inhibitor (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem). 15. Refusal to stop all opioids (to avoid precipitating opioid withdrawal). 16. Refusal to discontinue all alcohol (to reduce the risk of respiratory depression). 17. Hepatic impairment (AST/ALT > 1. 5 times upper normal). 18. Estimated Glomerular Filtration Rate (GFR) < 20 ml/min. 19. Inability/refusal to identify a person as an emergency contact. 20. Pregnancy

Locations and Contacts

Julia Schweiger, CCRC, Phone: 314-362-3153, Email: schweigj@psychiatry.wustl.edu

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Not yet recruiting
Additional Information

Starting date: August 2014
Last updated: July 3, 2014

Page last updated: August 23, 2015

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