Trial Outcomes & Findings for Lisdexamfetamine Dimesylate in Residual Symptoms and Cognitive Impairment in Major Depressive Disorder. (NCT NCT01148979)

Last Updated: 2017-05-23

Results Overview

The Montgomery-Asberg Depression Rating Scale Dysphoric Apathy Retardation subfactor (MDAR) is a 5-item subscale of the clinician-administered 10-item Montgomery-Asberg Depression Rating Scale (MADRS). MDAR score can range from 0-30 with a higher score representing a greater severity of depressive symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

Baseline to 4 weeks of treatment

Results posted on

2017-05-23

Participant Flow

35 potential subjects were screened for eligibility between September 2010 and April 2014 at McLean Hospital in Belmont, MA.

Of the 35 subjects screened, 29 were randomized. Of the 6 not randomized, 3 did not meet inclusion criteria, 1 withdrew consent, and 2 were lost to follow post screening. Of the 29 randomized, 28 completed both parts of the study. One subject was lost to follow after 3 weeks in the first half. Data were analyzed for the 28 completers only.

Participant milestones

Participant milestones
Measure	Placebo, Then Vyvanse Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d. Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg. Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.	Vyvanse, Then Placebo Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks. Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg. Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.
Overall Study STARTED	13	16
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo, Then Vyvanse Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d. Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg. Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.	Vyvanse, Then Placebo Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks. Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg. Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Lisdexamfetamine Dimesylate in Residual Symptoms and Cognitive Impairment in Major Depressive Disorder.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo, Then Vyvanse n=13 Participants Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate capsule each morning for 4 weeks. Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg. Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.	Vyvanse, Then Placebo n=16 Participants Participants first received Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks. Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg. Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.	Total n=29 Participants Total of all reporting groups
Age, Continuous	52.8 years STANDARD_DEVIATION 10.6 • n=5 Participants	48.9 years STANDARD_DEVIATION 11.4 • n=7 Participants	50.6 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 4 weeks of treatment

Population: All participants who completed all 4 weeks on both treatments (i.e., Placebo and Vyvanse) were included in the analysis.

Outcome measures

Outcome measures
Measure	Placebo Adjunct n=13 Participants Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d. Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg. Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.	Lisdexamfetamine Dimesylate (Vyvanse) n=15 Participants Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks. Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg. Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.
Change From Baseline in the Dysphoric Apathy/Retardation Sub-factor (MDAR) of Montgomery-Asberg Depression Rating Scale (MADRS) at 4 Weeks. Baseline Mean MDAR score	12.57 scores on a scale Standard Deviation 3.98	13.46 scores on a scale Standard Deviation 3.94
Change From Baseline in the Dysphoric Apathy/Retardation Sub-factor (MDAR) of Montgomery-Asberg Depression Rating Scale (MADRS) at 4 Weeks. Week 4 Mean MDAR score	9.08 scores on a scale Standard Deviation 5.51	6.36 scores on a scale Standard Deviation 5.54
Change From Baseline in the Dysphoric Apathy/Retardation Sub-factor (MDAR) of Montgomery-Asberg Depression Rating Scale (MADRS) at 4 Weeks. Change from BL in mean MDAR score	-3.49 scores on a scale Standard Deviation 4.66	-7.08 scores on a scale Standard Deviation 5.03

Adverse Events

Adjunct Lisdexamfetamine (Vyvanse)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Adjunct Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

J. Alexander Bodkin, MD

McLean Hospital

Phone: 617-855-3186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Adjunct Lisdexamfetamine (Vyvanse) n=28 participants at risk Participants receive Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks. Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.	Adjunct Placebo n=28 participants at risk Participants receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they receive Lisdexamfetamine Dimesylate capsule each morning for 4 weeks. Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.
General disorders decreased appetite	28.6% 8/28 • Adverse event data were collected over the 4 years of active subject participation.	7.1% 2/28 • Adverse event data were collected over the 4 years of active subject participation.
General disorders headache	10.7% 3/28 • Adverse event data were collected over the 4 years of active subject participation.	17.9% 5/28 • Adverse event data were collected over the 4 years of active subject participation.
General disorders dry mouth	25.0% 7/28 • Adverse event data were collected over the 4 years of active subject participation.	3.6% 1/28 • Adverse event data were collected over the 4 years of active subject participation.
General disorders insomnia	35.7% 10/28 • Adverse event data were collected over the 4 years of active subject participation.	10.7% 3/28 • Adverse event data were collected over the 4 years of active subject participation.
Psychiatric disorders irritability	10.7% 3/28 • Adverse event data were collected over the 4 years of active subject participation.	0.00% 0/28 • Adverse event data were collected over the 4 years of active subject participation.
Psychiatric disorders anxiety	14.3% 4/28 • Adverse event data were collected over the 4 years of active subject participation.	14.3% 4/28 • Adverse event data were collected over the 4 years of active subject participation.
Infections and infestations upper respiratory infection	3.6% 1/28 • Adverse event data were collected over the 4 years of active subject participation.	7.1% 2/28 • Adverse event data were collected over the 4 years of active subject participation.
General disorders fatigue	3.6% 1/28 • Adverse event data were collected over the 4 years of active subject participation.	7.1% 2/28 • Adverse event data were collected over the 4 years of active subject participation.
Gastrointestinal disorders gastrointesinal disturbance	3.6% 1/28 • Adverse event data were collected over the 4 years of active subject participation.	14.3% 4/28 • Adverse event data were collected over the 4 years of active subject participation.
Psychiatric disorders increased activation	0.00% 0/28 • Adverse event data were collected over the 4 years of active subject participation.	7.1% 2/28 • Adverse event data were collected over the 4 years of active subject participation.
General disorders diaphoresis	7.1% 2/28 • Adverse event data were collected over the 4 years of active subject participation.	3.6% 1/28 • Adverse event data were collected over the 4 years of active subject participation.
General disorders decreased libido	7.1% 2/28 • Adverse event data were collected over the 4 years of active subject participation.	3.6% 1/28 • Adverse event data were collected over the 4 years of active subject participation.
Infections and infestations stomach virus	0.00% 0/28 • Adverse event data were collected over the 4 years of active subject participation.	10.7% 3/28 • Adverse event data were collected over the 4 years of active subject participation.
Nervous system disorders tinnitus	7.1% 2/28 • Adverse event data were collected over the 4 years of active subject participation.	0.00% 0/28 • Adverse event data were collected over the 4 years of active subject participation.
Musculoskeletal and connective tissue disorders muscle tension	14.3% 4/28 • Adverse event data were collected over the 4 years of active subject participation.	0.00% 0/28 • Adverse event data were collected over the 4 years of active subject participation.
Cardiac disorders tachycardia	10.7% 3/28 • Adverse event data were collected over the 4 years of active subject participation.	0.00% 0/28 • Adverse event data were collected over the 4 years of active subject participation.
Nervous system disorders paresthesia	7.1% 2/28 • Adverse event data were collected over the 4 years of active subject participation.	0.00% 0/28 • Adverse event data were collected over the 4 years of active subject participation.