Trial Outcomes & Findings for Project to Improve Symptoms and Mood in People With Spinal Cord Injury (NCT NCT00592384)

Results Overview

The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

133 participants

Primary outcome timeframe

0 weeks, 12 weeks

Results posted on

2015-01-01

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Control placebo: identically encapsulated inactive substance	Venlafaxine XR venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
Overall Study STARTED	64	69
Overall Study COMPLETED	59	63
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Control placebo: identically encapsulated inactive substance	Venlafaxine XR venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
Overall Study Withdrawal by Subject	5	6

Baseline Characteristics

Project to Improve Symptoms and Mood in People With Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Control n=64 Participants placebo: identically encapsulated inactive substance	Venlafaxine XR n=69 Participants venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg	Total n=133 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 12 • n=99 Participants	39 years STANDARD_DEVIATION 11 • n=107 Participants	40 years STANDARD_DEVIATION 12 • n=206 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=99 Participants	69 Participants n=107 Participants	133 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	13 Participants n=99 Participants	21 Participants n=107 Participants	34 Participants n=206 Participants
Sex: Female, Male Male	51 Participants n=99 Participants	48 Participants n=107 Participants	99 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	23 Participants n=99 Participants	19 Participants n=107 Participants	42 Participants n=206 Participants
Race (NIH/OMB) White	38 Participants n=99 Participants	48 Participants n=107 Participants	86 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=99 Participants	3 Participants n=107 Participants	10 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=99 Participants	64 Participants n=107 Participants	119 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants

PRIMARY outcome

Timeframe: 0 weeks, 12 weeks

The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.

Outcome measures

Outcome measures
Measure	Placebo Control n=64 Participants placebo: identically encapsulated inactive substance	Venlafaxine XR n=69 Participants venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
Hamilton Depression Rating Scale-17 Baseline	19.5 units on a scale Standard Deviation 5.4	19.4 units on a scale Standard Deviation 5.5
Hamilton Depression Rating Scale-17 12-week outcome	9.5 units on a scale Standard Deviation 6.5	9.5 units on a scale Standard Deviation 7.3

PRIMARY outcome

Timeframe: 0 weeks, 12 weeks

The Maier is a 6-item sub scale of the Hamilton derived from Rasch analysis. It is a unidimensional scale with superior sensitivity to change. It excludes somatic items and is therefore especially appropriate for individuals who have substantial physical impairment and medical comorbidity. Scores can range from 0-22 with higher scores indicating more severe depression. Scores of 4 or less indicated in remission from depression.

Outcome measures

Outcome measures
Measure	Placebo Control n=64 Participants placebo: identically encapsulated inactive substance	Venlafaxine XR n=69 Participants venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
Hamilton Depression Rating Scale-Maier Subscale Baseline	8.7 units on a scale Standard Deviation 2.8	9.1 units on a scale Standard Deviation 2.9
Hamilton Depression Rating Scale-Maier Subscale 12-week outcome	3.9 units on a scale Standard Deviation 3.5	3.5 units on a scale Standard Deviation 3.6

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Venlafaxine XR

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Control n=64 participants at risk placebo: identically encapsulated inactive substance	Venlafaxine XR n=69 participants at risk venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
Injury, poisoning and procedural complications self-harm	0.00% 0/64 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)	1.4% 1/69 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)

Other adverse events

Other adverse events
Measure	Placebo Control n=64 participants at risk placebo: identically encapsulated inactive substance	Venlafaxine XR n=69 participants at risk venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
Renal and urinary disorders urinary tract infection	3.1% 2/64 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)	0.00% 0/69 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)
Cardiac disorders heart palpitations	0.00% 0/64 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)	1.4% 1/69 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)
Skin and subcutaneous tissue disorders urinary tract infection and pressure ulcer	0.00% 0/64 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)	1.4% 1/69 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)
Eye disorders blurry vision	1.6% 1/64 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)	0.00% 0/69 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)
Psychiatric disorders increased risk of suicide	1.6% 1/64 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)	0.00% 0/69 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)
Musculoskeletal and connective tissue disorders increased spasticity	1.6% 1/64 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)	0.00% 0/69 • Data were collected at each interim visit (weeks 1, 3, 6, 8, 10) and at the final outcome point (12 weeks)

Additional Information

Dr. Jesse R. Fann

University of Washington

Phone: 206 6854280

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60