ClinicalTrials.gov
ClinicalTrials.gov Menu

Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03002077
Recruitment Status : Active, not recruiting
First Posted : December 23, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Rapastinel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Long-term Safety Study of Rapastinel as Adjunctive Therapy in Patients With Major Depressive Disorder
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rapastinel
Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
Drug: Rapastinel
Rapastinel pre-filled syringes for IV injections.




Primary Outcome Measures :
  1. Safety and Tolerability of Rapastinel assessed by Examining the Frequency and Severity of Adverse Events (AE) [ Time Frame: 52 Weeks ]
    An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.


Secondary Outcome Measures :
  1. Change from Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+) [ Time Frame: Baseline to 52 Weeks ]
    The BPRS+ is a subset of the BPRS that assesses 4 components of the BPRS+ related to the degree of psychosis: Conceptual Disorganization, Suspiciousness, Hallucinatory Behavior, and Unusual Thought Content assessed by the investigator using a 7-point scale ranging from 1=Not Present to 7=Extremely Severe for a total possible score of 0 (best) to 28 (worst). A negative change from Baseline indicates improvement.

  2. Change from Baseline in the Clinician Administered Dissociative States Scale (CADSS) [ Time Frame: Baseline to 52 Weeks ]
    The CADSS is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during active dissociative experiences. A negative change from Baseline indicates improvement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
  • Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Screening
  • Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
  • If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

  • DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Screening
  • Lifetime history of meeting DSM-5 criteria for:

    1. Schizophrenia spectrum or other psychotic disorder
    2. Bipolar or related disorder
    3. Major neurocognitive disorder
    4. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
    5. Dissociative disorder
    6. Posttraumatic stress disorder
    7. MDD with psychotic features
  • Significant suicide risk, as judged by the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002077


  Show 137 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Robert Hayes, PhD Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03002077     History of Changes
Other Study ID Numbers: RAP-MD-06
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms