REL-1017 Expanded Access Treatment

Sponsor

Relmada Therapeutics, Inc. (Industry)

Overall Status

Available

CT.gov ID

NCT06009003

Collaborator

(none)

Study Details

Study Description

Brief Summary

To provide expanded access of REL-1017 to patients with MDD who do not have access to other effective therapy and are not eligible for other clinical trials with REL-1017

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Depression	Drug: REL-1017

Study Design

Study Type:

Expanded Access

Official Title:

REL-1017 Expanded Access Treatment

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients with Major Depressive Disorder who may potentially benefit from treatment with REL-1017 as determined by the treating physician.
Have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory alternative treatment is available to treat the disease or condition.
Are ineligible or unable to participate in any ongoing clinical study of the investigational product.
Condition for which, in the opinion of the treating physician, there is sufficient evidence of a potential benefit from the use of the investigational product, and that potential benefit outweighs the known or anticipated risks.
There is adequate information to support appropriate dosing for special population patients such as pediatric, elderly, renal or hepatic disease, etc.

Exclusion Criteria:

History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
History of allergy or hypersensitivity to methadone or related drugs.
Pregnant or planning to become pregnant.
Breast-feeding or planning to breast-feed.