Status:
COMPLETED
Low-Dose Naltrexone (LDN) for Depression Relapse and Recurrence
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Boston Clinical Trials
Conditions:
Major Depressive Disorder
Depression, Unipolar
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this pilot study is to determine if taking a low dose of naltrexone in addition to an antidepressant medication can help treat relapse or recurrence in people with Major Depressive Diso...
Detailed Description
We carried out a pilot double-blind, randomized, controlled study of low-dose naltrexone (LDN) 1 mg b.i.d. versus placebo augmentation in MDD patients who relapsed on dopaminergic agents. The primary ...
Eligibility Criteria
Inclusion
- Age 18-65.
- Written informed consent.
- Meet Diagnostic and Statistical Manual (DSM-IV) criteria by Structured Clinical Interview for DSM-IV (SCID-I/P) for Major Depressive Disorder (MDD), current.
- Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR) score of at least 12 at both screen and baseline visits.
- Received treatment with either an Selective serotonin re-uptake inhibitors (SSRI) in combination with a dopaminergic agent, or with an antidepressant with a dopaminergic mechanism of action in adequate doses, achieved remission per American College of Neuropsychopharmacology (ACNP) Task Force guidelines for ≥3 months, currently in relapse or recurrence without dose change for at least the past 4 weeks, based on meeting DSM-IV criteria for MDD.
- Dopaminergic agents here include classical stimulants from the amphetamine or methylphenidate families; dopamine agonists (e.g. pramipexole); or dopamine active antidepressants like bupropion.
- Additionally, low dose (\< 2.5 mg) Abilify, a D2 partial agonist, is believed to exert pro-dopaminergic effects and will therefore be included as a dopamine agent.
- Sertraline, although classified as an SSRI, has dopamine reuptake inhibiting properties believed to be relevant at higher doses (\> 150 mg of sertraline), and will also therefore be considered a dopaminergic antidepressant at dose range above.
- Based on the finding that the norepinephrine transporter is the reuptake inhibitor for dopamine in the prefrontal cortex and the robust sustained clinical response of a patient on duloxetine and low dose naltrexone, we include duloxetine, traditionally classed as an SNRI, among the dopamine acting antidepressants.)
- During the baseline visit, patients must be on a stable dose of antidepressant regimen for the past 4 weeks.
Exclusion
- Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy).
- Patients who no longer meet DSM-IV criteria for MDD during the baseline visit.
- Patients who demonstrate a greater than 25% decrease in depressive symptoms as reflected by the QIDS-SR total score - screen to baseline.
- Serious suicide or homicide risk, as assessed by evaluating clinician.
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
- Substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past).
- History of a seizure disorder or clinical evidence of untreated hypothyroidism.
- Patients requiring excluded medications (including but not limited to chronic or episodic use of anorexiants, episodic hormones, episodic benzodiazepines, episodic insulin, episodic and other episodic psychotropic medications).
- Psychotic features in the current episode or a history of psychotic features, as assessed by SCID.
- History of naltrexone intolerance at any dose.
- Patients with a history of antidepressant-induced hypomania.
- Inadequate exposure time or dose of current SSRI or Serotonin-norepinephrine reuptake inhibitor (SNRI); failure to comply with at least 80% of doses.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01874951
Start Date
June 1 2013
End Date
June 1 2015
Last Update
February 24 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital; Depression Research and Clinical Program
Boston, Massachusetts, United States, 02114