A Phase 3 interventional study of Rapastinel and Placebo in Depressive Disorder, Major, sponsored by Naurex, Inc, an affiliate of Allergan plc. Completed at 40 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Naurex, Inc, an affiliate of Allergan plc (part of AbbVie) · Phase 3, Interventional, and Treatment
This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's enrollment of 429 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Naurex, Inc, an affiliate of Allergan plc is the lead sponsor of 20 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
First submitted before Naurex, Inc became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Lifetime history of meeting DSM-5 criteria for:
Rapastinel 450 mg weekly intravenous (IV) injections. 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
Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
Drug: Placebo
Rapastinel pre-filled syringes for weekly IV injections.
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Time frame: Baseline and 3 Weeks
Change From Baseline in MADRS Total Score
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Time frame: Baseline and Day 8
Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Time frame: Baseline and Day 21
Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Time frame: Baseline and Day 8
| Milestone | Placebo | Rapastinel 450 mg |
|---|---|---|
| Started | 209 | 206 |
| Completed | 204 | 201 |
| Not completed | 5 | 5 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Adverse event | 3 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Pregnancy | 1 | 0 |
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
| Score on a Scale | Placebo | Rapastinel 450 mg |
|---|---|---|
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study | -4.1 ± 0.64 | -5.1 ± 0.66 |
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
| Score on a Scale | Placebo | Rapastinel 450 mg |
|---|---|---|
| Change From Baseline in MADRS Total Score | -4.3 ± 0.53 | -3.9 ± 0.55 |
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
| Score on a Scale | Placebo | Rapastinel 450 mg |
|---|---|---|
| Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population | -4.6 ± 0.72 | -4.6 ± 0.74 |
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
| Score on a Scale | Placebo | Rapastinel 450 mg |
|---|---|---|
| Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population | -4.1 ± 0.61 | -3.6 ± 0.62 |
Collected over Adverse Events were collected for up to 28 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 1/209 (0.5%) | 3/209 (1.4%) | 18/209 (8.6%) |
| Rapastinel 450 mg | 0/206 (0%) | 0/206 (0%) | 15/206 (7.3%) |
| Event | Placebo | Rapastinel 450 mg |
|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/151 | 0/156 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/209 | 0/206 |
| Subarachnoid haemorrhageNervous system disorders | 1/209 | 0/206 |
| Event | Placebo | Rapastinel 450 mg |
|---|---|---|
| HeadacheNervous system disorders | 18/209 | 15/206 |
The modified Intent-to-Treat (mITT) Population will consist of all patients who were randomized, received at least 1 dose of IP during the randomized treatment period, and had at least 1 post-randomization assessment of the MADRS total score.
| Age, Continuous(Years) | Placebo | Rapastinel 450 mg | Total |
|---|---|---|---|
| Mean | 46.4 ± 11.93 | 47.4 ± 11.34 | 46.9 ± 11.64 |
| Sex: Female, Male(Participants) | Placebo | Rapastinel 450 mg | Total |
|---|---|---|---|
| Female | 151 | 156 | 307 |
| Male | 58 | 50 | 108 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Rapastinel 450 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 25 | 34 | 59 |
| Not Hispanic or Latino | 184 | 172 | 356 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo | Rapastinel 450 mg | Total |
|---|---|---|---|
| White | 156 | 157 | 313 |
| Black or African American | 48 | 45 | 93 |
| Asian | 3 | 3 | 6 |
| American Indian or Alaska Native | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| MADRS total score at baseline(Scores on a Scale) | Placebo | Rapastinel 450 mg | Total |
|---|---|---|---|
| Mean | 33.8 ± 4.83 | 34.1 ± 4.73 | 34.0 ± 4.76 |
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GLYX-13 peptide
Naurex, Inc, an affiliate of Allergan plc →