Trial Outcomes & Findings for Functional MRI Before and After Treatment for Depression (NCT NCT00896441)

Results Overview

Utilized the Hamilton Depression Rating Scale (HAM), 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores indicate more depression. For the change score, it is Baseline less Day 56 HAM total / Baseline. Thus, larger values mean a greater decrease in the level of depression

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

% change from baseline to Day 56 ( week 8)

Results posted on

2017-10-13

Participant Flow

5 participants in the Healthy controls group withdrew consent prior to allocation to study arm.

Participant milestones

Participant milestones
Measure	Depressed Depressed individuals	Healthy Controls Participants with no history of psychiatric illness
Overall Study STARTED	17	9
Overall Study COMPLETED	15	9
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Functional MRI Before and After Treatment for Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Depressed n=15 Participants Depressed individuals	Healthy Controls n=9 Participants Participants with no history of psychiatric illness	Total n=24 Participants Total of all reporting groups
Age, Continuous	40.00 years STANDARD_DEVIATION 12.6 • n=5 Participants	31.92 years STANDARD_DEVIATION 11.2 • n=7 Participants	36.50 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: % change from baseline to Day 56 ( week 8)

Population: Only participants completing the protocol are included in the analysis; thus, the N = 12. Only participants in the Depressed group were analyzed for change in depressive symptoms.

Utilized the Hamilton Depression Rating Scale (HAM), 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores indicate more depression. For the change score, it is Baseline less Day 56 HAM total / Baseline. Thus, larger values mean a greater decrease in the level of depression

Outcome measures

Outcome measures
Measure	Depressed n=12 Participants Depressed individuals
Hamilton Depression Rating Scale Percent Change From Day 0 to D56	.4125 percentage of change in depression Standard Deviation .26

PRIMARY outcome

Timeframe: baseline and week 8

Population: Owing to the limited sample size, we first examined this measure in the depressed subjects using a paired-sample t-test at each of the 30,000+ voxels. No significant voxels were detected in this analysis and so subsequent analyses combining the depressed subjects and the healthy control subjects in a single model were not performed.

The dependent variable, measured in more than 30,000 voxels across the whole brain, was the functional connectivity between the posterior cingulate cortex seed region and each voxel. This is derived as the correlation coefficient between the blood-oxygen-level dependent (BOLD) signal timeseries in the seed region and the BOLD signal timeseries in each voxel.

Outcome measures

Outcome measures
Measure	Depressed n=13 Participants Depressed individuals
Voxel-wise Changes in Resting State Functional Connectivity to the Posterior Cingulate Cortex	0 significant voxels

SECONDARY outcome

Timeframe: % change in anxiety from Day 1 to Day 56 (week 8)

Population: Only participants completing the protocol are included in the analysis. Only participants in the Depressed group were analyzed for change in anxiety symptoms.

Hamilton Anxiety Scale (HAMA) was utilized. Scores range from 0-56, with higher scores indicating more anxiety. The change score utilized baseline and Day 56 (week 8) scores. The change scores was HAMA day 1 less Ham A day 56 / HAMA Day 1. Thus, larger numbers equal a greater reduction in anxiety.

Outcome measures

Outcome measures
Measure	Depressed n=12 Participants Depressed individuals
Hamilton Anxiety Scale	.3988 percentage of change in anxiety Standard Deviation .43

Adverse Events

Depressed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mike Greicius

Stanford University

Phone: 650-723-8331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place