Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine
Information source: Centre for Addiction and Mental Health
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 (Drug); buprenorphine (Drug); placebo (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Centre for Addiction and Mental Health Official(s) and/or principal investigator(s): Daniel M Blumberger, MD, Principal Investigator, Affiliation: CAMH
Overall contact: Daniel M Blumberger, MD, Phone: 416-535-8501, Ext: 33662, Email: daniel.blumberger@camh.ca
Summary
The Investigators are conducting a research study to learn about the safety and benefit of
using a medication called buprenorphine for patient 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 medication 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
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: The Montgomery-Asberg Depression Rating ScaleFrequency, Intensity, and Burden of Side Effects Rating (FIBSER) Antidepressant Side Effect Checklist (ASEC)
Secondary outcome: Suicidal Ideation Scale ( SIS)Brief Symptom Inventory for Anxiety Numeric Scale of Pain ( NRS-P)
Detailed description:
The aim of this study is to examine the feasibility, safety, and tolerability of
buprenorphine (BPN) as a novel treatment for late-life treatment resistant depression
(LL-TRD). The investigators aim to use a clinical trial methodology common to all three
sites, and to examine the mechanism of action (MOA) of BPN using translational neuroscience
methods. Over ½ of seniors with depression fail to respond to traditional
antidepressants. 19,20 Modulation of the opiate system with BPN offers a novel mechanistic
approach to improve the lives of patients with LL-TRD, with a safety profile potentially
superior to current augmentation strategies such as antipsychotics, lithium, ECT, and
surgical interventions (e. g., deep brain or vagal nerve stimulation).
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age > 50 years
2. Major depressive disorder (MDD), single or recurrent, as diagnosed by the SCID-IV (or
SCID-5 if available)
3. MADRS > 15
4. Has or agrees to establish a clinical relationship with primary care physician (PCP).
5. Availability of an informant (e. g., emergency contact) is encouraged but not required
for study participation
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
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 score of > 8 on AUDIT-C 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 or buprenorphine as determined by PCP and study
physician including history of intolerance of either venlafaxine or buprenorphine in
the study target dosage range (venlafaxine at up to 300 mg/day; buprenorphine 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 32 - 36 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 opiate 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, ketonazole, nefazodone, saquinovir,
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
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Locations and Contacts
Daniel M Blumberger, MD, Phone: 416-535-8501, Ext: 33662, Email: daniel.blumberger@camh.ca
Centre for Addiction and Mental Health, Toronto, Ontario M6J1H4, Canada; Recruiting Minhquan Nguyen, BSc, Phone: 416-535-8501, Ext: 33532, Email: Minhquan.Nguyen@camh.ca
Additional Information
Starting date: December 2014
Last updated: March 6, 2015
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