Trial Outcomes & Findings for Effects of Cerebral Hypoperfusion and Its Reversal on Late-Life Depression (NCT NCT01794455)

Results Overview

MRI arterial spin labeling is a noninvasive approach to measuring cerebral blood flow. This relates to the Phase 1 sertraline arm.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Change in perfusion from baseline to week 8

Results posted on

2016-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1: Sertraline Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily. Sertraline: 50mg - 200mg daily	Phase 2: Candesartan For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily. Candesartan: 4mg - 32mg daily
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Cerebral Hypoperfusion and Its Reversal on Late-Life Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: Sertraline Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily. Sertraline: 50mg - 200mg daily	Phase 2: Candesartan n=1 Participants For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily. Candesartan: 4mg - 32mg daily	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical >=65 years	—	1 participants n=7 Participants	1 participants n=5 Participants
Age, Continuous	—	67 years n=7 Participants	67 years n=5 Participants
Gender Female	—	0 participants n=7 Participants	0 participants n=5 Participants
Gender Male	—	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Change in perfusion from baseline to week 8

Population: Could not complete MRI.

MRI arterial spin labeling is a noninvasive approach to measuring cerebral blood flow. This relates to the Phase 1 sertraline arm.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 8

MADRS is a measure of depression severity. This outcome applies to the sertraline Phase 1 arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 8

Self-report measure of depression severity. This applies to the sertraline Phase 1 arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 20

Self-report measure of depression severity (range 0 - 27, higher scores indicate more severe depressive symptoms). This applies to the candesartan Phase 2 arm.

Outcome measures

Outcome measures
Measure	Phase 1: Sertraline Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily. Sertraline: 50mg - 200mg daily	Phase 2: Candesartan n=1 Participants For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily. Candesartan: 4mg - 32mg daily
Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)	—	11 units on a scale

SECONDARY outcome

Timeframe: Week 20

MADRS is a measure of depression severity (range 0 - 60, higher scores indicate more severe depressive symptoms). This outcome applies to the candesartan Phase 2 arm.

Outcome measures

Outcome measures
Measure	Phase 1: Sertraline Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily. Sertraline: 50mg - 200mg daily	Phase 2: Candesartan n=1 Participants For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily. Candesartan: 4mg - 32mg daily
Montgomery-Asberg Depression Rating Scale	—	22 units on a scale

SECONDARY outcome

Timeframe: Change from week 8 to week 20

Population: MRI data could not be obtained on the one study participant due to MRI contraindications.

MRI arterial spin labeling is a noninvasive approach to measuring cerebral blood flow. This relates to the Phase 2 candesartan arm.

Outcome measures

Outcome data not reported

Adverse Events

Phase 1: Sertraline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 2: Candesartan

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Phase 1: Sertraline Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily. Sertraline: 50mg - 200mg daily	Phase 2: Candesartan n=1 participants at risk For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily. Candesartan: 4mg - 32mg daily
Gastrointestinal disorders Nausea	— 0/0 • 12 weeks	100.0% 1/1 • Number of events 1 • 12 weeks
General disorders Fatigue	— 0/0 • 12 weeks	100.0% 1/1 • Number of events 1 • 12 weeks

Additional Information

Dr. Warren Taylor

Vanderbilt University

Phone: 615-936-3555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place