Trial Outcomes & Findings for Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression (NCT NCT01670019)

Results Overview

The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

Baseline, 6 weeks

Results posted on

2015-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Asenapine 5-20 mg Daily Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID	Placebo 1-4 Tablets Daily Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Overall Study STARTED	23	23
Overall Study COMPLETED	14	23
Overall Study NOT COMPLETED	9	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Asenapine 5-20 mg Daily Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID	Placebo 1-4 Tablets Daily Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Overall Study Adverse Event	3	0
Overall Study Withdrawal by Subject	6	0

Baseline Characteristics

Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asenapine 5-20 mg Daily n=23 Participants Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID	Placebo 1-4 Tablets Daily n=23 Participants Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID	Total n=46 Participants Total of all reporting groups
Age, Continuous	44.39 years STANDARD_DEVIATION 11.34 • n=5 Participants	45.87 years STANDARD_DEVIATION 12.016 • n=7 Participants	45.13 years STANDARD_DEVIATION 11.59 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks

Population: Analysis includes those participants who completed week 6 assessment.

The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.

Outcome measures

Outcome measures
Measure	Asenapine 5-20 mg Daily n=14 Participants Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID	Placebo 1-4 Tablets Daily n=23 Participants Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Change in MADRS Total Score	-14.29 units on a scale Standard Deviation 9.73	-11.61 units on a scale Standard Deviation 11.82

SECONDARY outcome

Timeframe: 6 weeks

The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks

Outcome measures

Outcome measures
Measure	Asenapine 5-20 mg Daily n=23 Participants Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID	Placebo 1-4 Tablets Daily n=23 Participants Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Study Completion Rate	60.87 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Clinical Response rate will be defined as the number of participants with a \> 50% reduction from baseline in MADRS total score. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.

Outcome measures

Outcome measures
Measure	Asenapine 5-20 mg Daily n=14 Participants Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID	Placebo 1-4 Tablets Daily n=23 Participants Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Clinical Response Rate	7 participants	12 participants

SECONDARY outcome

Timeframe: 6 weeks

Clinical Remission will be defined as the number of participants with a MADRS total score \< 7. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.

Outcome measures

Outcome measures
Measure	Asenapine 5-20 mg Daily n=14 Participants Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID	Placebo 1-4 Tablets Daily n=23 Participants Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Clinical Remission Rate	5 participants	5 participants

SECONDARY outcome

Timeframe: 2, 4, 6 weeks

Population: Participants that completed all data collection timepoints at week 2, 4, 6.

Sustained remission will be defined as at least two consecutive post-randomization assessments (weeks 2, 4, and 6) during which minimal depressive psychopathology (MADRS \< 7) is present. MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.

Outcome measures

Outcome measures
Measure	Asenapine 5-20 mg Daily n=13 Participants Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID	Placebo 1-4 Tablets Daily n=23 Participants Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Rates of Sustained Remission	4 participants	4 participants

Adverse Events

Asenapine 5-20 mg Daily

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo 1-4 Tablets Daily

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Asenapine 5-20 mg Daily n=23 participants at risk Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID	Placebo 1-4 Tablets Daily n=23 participants at risk Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Psychiatric disorders Insomnia	47.8% 11/23	47.8% 11/23
Psychiatric disorders Excessive daytime sedation	43.5% 10/23	52.2% 12/23
Gastrointestinal disorders Oral/ Lingual dysaethesia	21.7% 5/23	8.7% 2/23
Nervous system disorders orthostasis faintness	8.7% 2/23	26.1% 6/23

Additional Information

John Beyer, M.D.

Duke University

Phone: 919-668-0209

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place