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Opioid Partial Agonist

Brain Stimulation for Depression (RAISE Trial)

Phase 4

Recruiting

Led By Marta Peciña, MD, PhD

Research Sponsored by Marta Peciña, MD PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No more than one failed antidepressant trial of adequate dose and duration, as defined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ);

No more than one failed antidepressant trial of adequate dose and duration, as defined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ)

Must not have

Any individual who has failed the naloxone challenge test or who has a positive urine screen for opioids

Patients are receiving opioid analgesics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately at day 7, 14, 21.

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is investigating whether two different types of brain stimulation can help relieve symptoms of depression.

Who is the study for?

Adults aged 18-55 with major depression, who have tried at most one antidepressant without success, can join this trial. They must be fluent in English and off antidepressants for at least 21 days. People with a history of psychotic disorders, substance dependence (except nicotine), or those currently suicidal or on certain psychiatric medications cannot participate.

What is being tested?

The study tests if stimulating the brain's reward system using TMS and altering opioid signals with buprenorphine/naltrexone can improve depression symptoms. Participants will receive either real treatments or placebos to compare effects.

What are the potential side effects?

Possible side effects include discomfort from brain stimulation, reactions to medication like buprenorphine/naltrexone such as nausea, dizziness, or headaches. Placebo treatments may not cause direct side effects but won't provide active treatment benefits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tried only one antidepressant without success, as per the MGH-ATRQ standards.

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I have tried only one antidepressant without success, as per the MGH-ATRQ standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I failed the naloxone test or tested positive for opioids.

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I am currently taking opioid pain medication.

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I have epilepsy or need medication to prevent seizures.

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I am currently undergoing treatments like vagus nerve stimulation or magnetic brain therapy.

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I am currently on medication for mental health or mood enhancement.

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I do not have conditions or devices that could be affected by magnetic fields.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately at day 7, 14, 21.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately at day 7, 14, 21.

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately at day 7, 14, 21. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BOLD Responses in the vmPFC-VS circuit

Opioid Modulation Effects on BOLD Responses in the vmPFC-VS circuit

TBS Effects of BOLD Response

Side effects data

From 2014 Phase 3 trial • 815 Patients • NCT01675167

17%

Nausea

Constipation

Vomiting

Headache

Dizziness

Somnolence

Drug withdrawal syndrome

100%

80%

60%

40%

20%

Study treatment Arm

OL Buprenorphine HCl Buccal Film

DB Buprenorphine HCl Buccal Film

DB Placebo Film

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Oral Placebo Pill + Intramuscular Saline InjectionExperimental Treatment3 Interventions

Inert pill and saline injection that have no inherent power to produce an effect. In the inert pill condition, participants will receive one IM arm injection of saline (1ML) and an oral placebo tablet.

Group II: Naltrexone Oral Tablet + Intramuscular Saline InjectionExperimental Treatment3 Interventions

Naltrexone is thought to strongly block μ-opioid receptors. Oral (pill) opioid antagonist which will be used to modulate reward learning signals to understand placebo effects in participants with depression. In the naltrexone condition, participants will receive one tablet of 50mg Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: \~1 hour; duration: \~24 hours) and a saline IM injection.

Group III: Buprenorphine Injection + Oral Placebo PillExperimental Treatment3 Interventions

Buprenorphine is a μ-opioid partial agonist and kappa-opioid antagonist that is used to treat moderate to severe pain and opioid dependence. The intramuscular administered opioid agonist which will be used to modulate reward learning signals to understand placebo effects in patients with depression. In the buprenorphine condition, participants will receive one IM injection of 0.3mg/1ML buprenorphine hydrochloride (Buprenex®. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc.; 2006) (onset of action: ≥15 minutes; peak effect: \~1 hour; duration: \~6 hours) and an oral placebo tablet.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Buprenorphine

2014

Completed Phase 4

~2600

Naltrexone

2005

Completed Phase 4

~2420