Trial Outcomes & Findings for Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine (NCT NCT02969876)

NCT ID: NCT02969876

Last Updated: 2019-10-14

Results Overview

This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 2 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2019-10-14

Participant Flow

Participant milestones

Measure	Open Trial Vortioxetine All enrolled participants received open trial of Vortioxetine for 6 weeks.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine

Baseline characteristics by cohort

Measure	Study Phase n=2 Participants During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical \& Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks. Vortioxetine: Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.
Age, Continuous	20.5 years STANDARD_DEVIATION 3.54 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome.

Outcome measures

Measure

Study Phase n=2 Participants During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical \& Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks. Vortioxetine: Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.

Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)

12.5 score on a scale Standard Deviation 10.60

SECONDARY outcome

Timeframe: 6 weeks

A cognitive measure sensitive to learning and memory. Participants are given 90 seconds to match as many symbols to numbers according to a key located on the top of the page. A higher score means a better outcome.

Outcome measures

Measure

Study Phase n=2 Participants During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical \& Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks. Vortioxetine: Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.

Digital Symbol Substitution Test

41.5 number of substitutions Standard Deviation 1.5

SECONDARY outcome

Timeframe: 6 weeks

A cognitive measure sensitive to learning and memory. Minimum score is a zero. Maximum score is a 75. A higher score means a better outcome

Outcome measures

Measure

Study Phase n=2 Participants During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical \& Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks. Vortioxetine: Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.

Rey Auditory Verbal Learning Test

54 number of words recalled Standard Deviation 1

Adverse Events

Open Trial Vortioxetine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Open Trial Vortioxetine n=2 participants at risk All enrolled participants received open trial of Vortioxetine for 6 weeks.
Musculoskeletal and connective tissue disorders Tripped, hit knee, went to ER	50.0% 1/2 • 9 months
General disorders Migraines	50.0% 1/2 • Number of events 1 • 9 months
General disorders Headaches	50.0% 1/2 • 9 months

Additional Information

Dr. Andrew Nierenberg

Massachusetts General Hospital

Phone: 6175122641

Email: anierenberg@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place