Low-Dose Naltrexone for Depression Relapse and Recurrence
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | June 2013 |
| End Date: | June 2015 |
Randomized, Proof-Of-Concept Trial of Augmentation of Anti-depressants by Low Dose and Ultra-Low Dose Naltrexone for Patients With Breakthrough Symptoms of Major Depressive Disorder on Antidepressant Therapy
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 Disorder (MDD). The U.S. Food and Drug Administration (FDA) has approved
naltrexone for the treatment of alcohol dependence and opioid dependence, but the FDA has
not approved naltrexone to treat depression. The investigators hypothesize that patients
with breakthrough depression on an antidepressant regimen containing a pro-dopaminergic
agent assigned to treatment with low dose naltrexone will demonstrate higher rates of
response compared to those patients taking placebo.
addition to an antidepressant medication can help treat relapse or recurrence in people with
Major Depressive Disorder (MDD). The U.S. Food and Drug Administration (FDA) has approved
naltrexone for the treatment of alcohol dependence and opioid dependence, but the FDA has
not approved naltrexone to treat depression. The investigators hypothesize that patients
with breakthrough depression on an antidepressant regimen containing a pro-dopaminergic
agent assigned to treatment with low dose naltrexone will demonstrate higher rates of
response compared to those patients taking placebo.
Inclusion Criteria:
- Age 18-65.
- Written informed consent.
- Meet 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 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.
1. Dopaminergic agents here include classical stimulants from the amphetamine or
methylphenidate families; dopamine agonists (e.g. pramipexole); or dopamine
active antidepressants like bupropion.
2. 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.
3. 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.
4. 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 Criteria:
- 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.
We found this trial at
1
site
Boston, Massachusetts 02114
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