Trial Outcomes & Findings for Frontal Hypoperfusion Effects on Antidepressant Outcomes in Late-Life Depression (NCT NCT01896934)

NCT ID: NCT01896934

Last Updated: 2017-07-21

Results Overview

Montgomery-Asberg Depression Rating Scale (MADRS) is a measure of depression severity. This will be used to define remission as a score of 7 or less.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2017-07-21

Participant Flow

Participants taking ineffective antidepressant medications underwent a washout period. 10 recruited individuals were withdrawn after screening for a) concomitant medications (N=2), b) depression not severe (N=4), c) MRI contraindications (N=4)

Participant milestones

Measure	Sertraline 50-200mg daily Sertraline: 50-200mg daily
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Sertraline 50-200mg daily Sertraline: 50-200mg daily
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Baseline data missing for 4 individuals (3 subject did not complete, 1 deviation where questionnaire was not provided to subject)

Baseline characteristics by cohort

Measure	Sertraline n=21 Participants 50-200mg daily
Age, Categorical <=18 years	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=21 Participants
Age, Categorical >=65 years	13 Participants n=21 Participants
Age, Continuous	68.05 years STANDARD_DEVIATION 7.15 • n=21 Participants
Sex: Female, Male Female	13 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=21 Participants
Race (NIH/OMB) White	18 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants
Region of Enrollment United States	21 participants n=21 Participants
Montgomery-Asberg Depression Rating Scale	27.43 units on a scale STANDARD_DEVIATION 4.80 • n=21 Participants
Quick Inventory of Depressive Symptoms	11.94 units on a scale STANDARD_DEVIATION 4.5 • n=17 Participants • Baseline data missing for 4 individuals (3 subject did not complete, 1 deviation where questionnaire was not provided to subject)

PRIMARY outcome

Timeframe: Week 12

Population: Individuals achieving remission of depression, defined as MADRS score of 7 or less.

Montgomery-Asberg Depression Rating Scale (MADRS) is a measure of depression severity. This will be used to define remission as a score of 7 or less.

Outcome measures

Measure	Sertraline n=21 Participants 50-200mg daily Sertraline: 50-200mg daily
Remission of Depression	10 Participants

SECONDARY outcome

Timeframe: Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported

Change in depression severity will be measured by the clinician-rated Montgomery Asberg Depression Rating Scale (MADRS), range of 0-60, with higher scores indicating more severe depression

Outcome measures

Measure	Sertraline n=21 Participants 50-200mg daily Sertraline: 50-200mg daily
Change in Clinician-rated Depression Severity	16.14 units on a scale Standard Deviation 9.84

SECONDARY outcome

Timeframe: Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported

Change in depression severity measured by the patient-rated Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16). The QIDS-SR16 is a self-report measure of depression severity with a range of 0-27, with higher scores indicative of more severe depression.

Outcome measures

Measure	Sertraline n=17 Participants 50-200mg daily Sertraline: 50-200mg daily
Change in Patient-rated Depression Severity	3.82 units on a scale Standard Error 6.04

Adverse Events

Sertraline

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sertraline n=21 participants at risk 50-200mg daily
Infections and infestations Upper Respiratory Infection	9.5% 2/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
Eye disorders Vision changes	4.8% 1/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
Eye disorders Dry Eyes	4.8% 1/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
Nervous system disorders Vivid Dreams	4.8% 1/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
Nervous system disorders Headache	14.3% 3/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
Nervous system disorders Tremor	4.8% 1/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
Musculoskeletal and connective tissue disorders Muscle cramps	4.8% 1/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
Gastrointestinal disorders Nausea	4.8% 1/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
Gastrointestinal disorders Constipation	4.8% 1/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
Gastrointestinal disorders Dry Mouth	9.5% 2/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
General disorders Fatigue	14.3% 3/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.
Reproductive system and breast disorders Sexual Dysfunction	9.5% 2/21 • 12 weeks Adverse events and serious adverse event definitions are concordant with clinicaltrials.gov definitions. Adverse events were assessed at every contact by asking individuals about any medical problems or potential side effects they were experiencing.

Additional Information

Dr. Warren D Taylor

Vanderbilt University Medical Center

Phone: 615-936-3555

Email: warren.d.taylor@vanderbilt.edu

Results disclosure agreements

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