Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

Allergan

Status and phase: Terminated; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Rapastinel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03668600

RAP-MD-99

Details and patient eligibility

About

Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.

Enrollment: 230 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of lead-in study
• Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator

Exclusion criteria

• Suicide risk, as determined by meeting any of the following criteria:

  1. A suicide attempt within the past year
  2. Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study
  3. Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted.

• At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator

• Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation

• Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

Rapastinel

Experimental group

Description:

Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)

Treatment:

Drug: Rapastinel