Major Depression Study – Adjunctive Therapy for Adults
REL-1017 vs Placebo as Adjunctive Treatment for MDD
$75 per completed visit
- REL-1017 vs Placebo – This is a double blind study in which subjects are randomly placed on either REL-1017 or Placebo as adjunctive treatment to their current antidepressant. Dr. Handal will be able to find out what medication the subject is on in case of emergency.
- This is a 4-week treatment period.
- Participants are reimbursed $75 for their time and travel at the end of each completed visit.
- Must be between the ages of 19-65
- Current depressive episode of at least 8 weeks and not exceeding 24 months in duration before screening.
- Have had an inadequate response to at least 1 but no more than 3 antidepressants at an adequate dose (at or above the minimum therapeutic dose) and duration (at least 6 weeks) in the current depressive episode. An inadequate response is defined as <50% reduction but with some improvement during the current antidepressant trial. There may be some minor or moderate symptomatic improvement since the initiation of treatment, but some of the initial symptoms are still present, troubling to the participant and affecting behavior and function.
- BMI Between 18 and 35 kg
- Any depressive episode with psychotic or catatonic features.
- Any anxiety disorder that has been the primary focus of treatment w/in the past 6 months (rendering MDD secondary to anxiety).
- Any manic or hypomanic episode whether due to bipolar I or II, or medication/substance-induced.
- Bipolar, schizophrenia, schizoaffective disorder, or other psychotic illness.
- OCD, PTSD, or panic disorder with or w/out agoraphobia active within the past 12 months.
- Personality disorders of sufficient severity that may interfere with study participation.
- Alcohol or substance use disorder within 12 months of screening.
- Electroconvulsive therapy (ECT), Vagus nerve stimulation (VNS), or any other type of physical brain stimulation.
- Cannot have had transcranial magnetic stimulation (TMS) 6 months prior to screening.
- Suicidal attempt within the current depressive episode or within the past year.
- Psychiatric hospitalization during the current major depressive episode.
- History of seizure disorder, undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs or any conditions that would increase the risk of seizures i.e. stroke, head injury, tumor or CNS infection, etc.
- Positive breath alcohol test or urine drug screen at screening and baseline.
- Gastric bypass surgery or any procedure or disorder that would interfere with gastrointestinal transit or absorption.
- Initiation or termination of psychotherapy within 60 days prior to screening.
- Anxiolytics including benzodiazepines, antipsychotics, bupropion, anticonvulsants, bupropion, ketamine, memantine mood stabilizers, stimulants, and St. John's Wort are exclusionary and require a 30-day washout prior to baseline and for the duration of the study.
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