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 18, 2018
|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)|
|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|
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.
Rapastinel pre-filled syringes for IV injections.
- 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.
- 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.
- 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.
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
|Study Director:||Robert Hayes, PhD||Allergan|