Trial Outcomes & Findings for Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD) (NCT NCT03675776)

Last Updated: 2020-07-28

Results Overview

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 a 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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

50 participants

Primary outcome timeframe

Baseline to end of Week 6

Results posted on

2020-07-28

Participant Flow

Total of 68 participants were screened for eligibility; 50 participants randomized to receive double-blind treatment.

Participant milestones

Participant milestones
Measure	Placebo Placebo (prefilled syringe, weekly IV administration).	Rapastinel 225mg Rapastinel (prefilled syringe, weekly intravenous IV administration).	Rapastinel 450mg Rapastinel (prefilled syringe, weekly intravenous IV administration).
Double Blind Treatment Period STARTED	15	17	18
Double Blind Treatment Period COMPLETED	9	11	10
Double Blind Treatment Period NOT COMPLETED	6	6	8
Safety Follow-up Period STARTED	6	8	7
Safety Follow-up Period COMPLETED	6	8	7
Safety Follow-up Period NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo (prefilled syringe, weekly IV administration).	Rapastinel 225mg Rapastinel (prefilled syringe, weekly intravenous IV administration).	Rapastinel 450mg Rapastinel (prefilled syringe, weekly intravenous IV administration).
Double Blind Treatment Period Study Terminated by Sponsor	5	6	8
Double Blind Treatment Period Lack of Efficacy	1	0	0

Baseline Characteristics

Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=15 Participants Placebo (prefilled syringe, weekly IV administration).	Rapastinel 225mg n=17 Participants Rapastinel (prefilled syringe, weekly intravenous IV administration).	Rapastinel 450mg n=18 Participants Rapastinel (prefilled syringe, weekly intravenous IV administration).	Total n=50 Participants Total of all reporting groups
Age, Continuous	42.4 Years STANDARD_DEVIATION 10.36 • n=99 Participants	44.7 Years STANDARD_DEVIATION 10.83 • n=107 Participants	43.2 Years STANDARD_DEVIATION 11.06 • n=206 Participants	43.5 Years STANDARD_DEVIATION 10.60 • n=7 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	13 Participants n=107 Participants	7 Participants n=206 Participants	27 Participants n=7 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants	23 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=99 Participants	17 Participants n=107 Participants	18 Participants n=206 Participants	50 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	8 Participants n=99 Participants	7 Participants n=107 Participants	9 Participants n=206 Participants	24 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) White	7 Participants n=99 Participants	10 Participants n=107 Participants	9 Participants n=206 Participants	26 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Weight	73.86 kg STANDARD_DEVIATION 13.14 • n=99 Participants	69.58 kg STANDARD_DEVIATION 16.52 • n=107 Participants	70.32 kg STANDARD_DEVIATION 15.72 • n=206 Participants	71.13 kg STANDARD_DEVIATION 15.09 • n=7 Participants
Height	169.27 cm STANDARD_DEVIATION 10.68 • n=99 Participants	163.77 cm STANDARD_DEVIATION 5.90 • n=107 Participants	168.04 cm STANDARD_DEVIATION 6.36 • n=206 Participants	166.96 cm STANDARD_DEVIATION 7.97 • n=7 Participants
BMI	25.83 kg/m^2 STANDARD_DEVIATION 4.41 • n=99 Participants	25.85 kg/m^2 STANDARD_DEVIATION 5.50 • n=107 Participants	24.82 kg/m^2 STANDARD_DEVIATION 5.09 • n=206 Participants	25.47 kg/m^2 STANDARD_DEVIATION 4.97 • n=7 Participants
Montgomery-Asberg Depression Rating Scale (MADRS) total score at baseline	34.5 Score on a scale STANDARD_DEVIATION 4.34 • n=99 Participants	35.2 Score on a scale STANDARD_DEVIATION 4.78 • n=107 Participants	34.8 Score on a scale STANDARD_DEVIATION 4.72 • n=206 Participants	34.9 Score on a scale STANDARD_DEVIATION 4.54 • n=7 Participants

PRIMARY outcome

Timeframe: Baseline to end of Week 6

Population: The Modified Intent-to-Treat (mITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Placebo (prefilled syringe, weekly IV administration).	Rapastinel 225mg n=17 Participants Rapastinel (prefilled syringe, weekly intravenous IV administration).	Rapastinel 450mg n=18 Participants Rapastinel (prefilled syringe, weekly intravenous IV administration).
Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6).	-11.3 Score on a scale Standard Deviation 9.06	-21.3 Score on a scale Standard Deviation 10.31	-12.9 Score on a scale Standard Deviation 11.36

SECONDARY outcome

Timeframe: Baseline to 1 Day post-first dose

Population: The Modified Intent-to-Treat (mITT) Population consists of all patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Placebo (prefilled syringe, weekly IV administration).	Rapastinel 225mg n=17 Participants Rapastinel (prefilled syringe, weekly intravenous IV administration).	Rapastinel 450mg n=18 Participants Rapastinel (prefilled syringe, weekly intravenous IV administration).
Change From Baseline in MADRS Total Score at 1 Day After First Dose of Treatment	-6.7 Score on a scale Standard Deviation 5.36	-7.4 Score on a scale Standard Deviation 9.10	-6.4 Score on a scale Standard Deviation 9.11

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Rapastinel 225mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Rapastinel 450mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=15 participants at risk Placebo (prefilled syringe, weekly IV administration).	Rapastinel 225mg n=17 participants at risk Rapastinel (prefilled syringe, weekly intravenous IV administration).	Rapastinel 450mg n=18 participants at risk Rapastinel (prefilled syringe, weekly intravenous IV administration).
Infections and infestations Nasopharyngitis	6.7% 1/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	5.6% 1/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Psychiatric disorders Agitation	0.00% 0/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	5.6% 1/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Investigations Blood triglycerides increased	0.00% 0/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	5.6% 1/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
General disorders Feeling abnormal	0.00% 0/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	5.6% 1/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Psychiatric disorders Hallucination	0.00% 0/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	5.6% 1/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	5.6% 1/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	5.6% 1/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Ear and labyrinth disorders Vertigo	6.7% 1/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Vascular disorders Orthostatic hypotension	6.7% 1/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Infections and infestations Gastroenteritis	6.7% 1/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Investigations Alanine aminotransferase increased	6.7% 1/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Investigations Glucose urine present	6.7% 1/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
General disorders Drug withdrawal syndrome	6.7% 1/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Gastrointestinal disorders Abdominal discomfort	6.7% 1/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Infections and infestations Pharyngitis	6.7% 1/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Metabolism and nutrition disorders Dehydration	0.00% 0/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	5.9% 1/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).
Nervous system disorders Syncope	0.00% 0/15 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	5.9% 1/17 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).	0.00% 0/18 • The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period. Safety Population consists of all randomized patients who received at least 1 dose of randomized investigational product (IP).