Trial Outcomes & Findings for Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions (NCT NCT01368432)

NCT ID: NCT01368432

Last Updated: 2016-10-24

Results Overview

This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60. 0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; \>34 - severe depression. In this study the score was used as a continuous variable.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: MADRS score at baseline
• Results posted on: 2016-10-24

Participant Flow

Subjects were recruited from the Brain injury clinic at Johns Hopkins Bayview Medical Center, other Johns Hopkins outpatient clinics, and via advertisements in local papers.

One admitted to active alcohol abuse before initiating medications , and therefore no longer met inclusion criteria. Another consented but failed to return for any follow-up visits.

Participant milestones

Measure	Placebo The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Escitalopram Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Overall Study STARTED	6	8
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Placebo The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Escitalopram Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions

Baseline characteristics by cohort

Measure	Placebo n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Escitalopram n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: MADRS score at baseline

This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.

0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression.

In this study the score was used as a continuous variable.

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline	29.5 units on a scale Standard Deviation 3.9	33.6 units on a scale Standard Deviation 6.9

PRIMARY outcome

Timeframe: MADRS score at 12 weeks

This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.

0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression.

In this study the score was used as a continuous variable.

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Montgomery-Asberg Depression Rating Scale (MADRS)	11.2 units on a scale Standard Deviation 9.5	7 units on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: Baseline

This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7

1. = Normal-not at all ill

2. = Borderline mentally ill

3. = Mildly ill

4. = Moderately ill

5. = Markedly ill

6. = Severely ill

7. = Among the most extremely ill patients.

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Clinical Global Impression (CGI) - Severity at Baseline	4.5 units on a scale Standard Deviation 0.5	4.8 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: at 12 weeks

This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator.

The scores range from 1-7

1. = Very much improved

2. = Much improved

3. = Minimally improved

4. = No change

5. = Minimally worse

6. = Much worse

7. = Very much worse

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Clinical Global Impression (CGI)- Improvement	2.7 units on a scale Standard Deviation 1.2	2.1 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline

This outcome measure is assessing the participant's anxiety as assessed by the CAS.

The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable.

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Clinical Anxiety Scale (CAS)	9.8 units on a scale Standard Deviation 3.8	14.8 units on a scale Standard Deviation 6.7

SECONDARY outcome

Timeframe: 12 weeks

This outcome measure is assessing the participant's anxiety as assessed by the CAS.

The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable.

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Clinical Anxiety Scale (CAS)	6.3 units on a scale Standard Deviation 4.3	3.9 units on a scale Standard Deviation 5

SECONDARY outcome

Timeframe: baseline

This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.

The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).

It is used as continuous variable.

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Satisfaction With Life (SWL)	13.8 units on a scale Standard Deviation 7.7	15.6 units on a scale Standard Deviation 9.3

SECONDARY outcome

Timeframe: 12 weeks

This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.

The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).

It is used as continuous variable.

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Satisfaction With Life (SWL)	21.2 units on a scale Standard Deviation 9.2	22.6 units on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: At baseline

This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.

Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable.

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Quality of Life (QWL)	62.8 units on a scale Standard Deviation 22.3	64.1 units on a scale Standard Deviation 24.6

SECONDARY outcome

Timeframe: At 12 weeks

This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.

Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable.

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Quality of Life (QWL)	75.2 units on a scale Standard Deviation 30.3	78.7 units on a scale Standard Deviation 17.3

SECONDARY outcome

Timeframe: At baseline

This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.

Scores range from 0 (normal) and 29 (extreme vegetative state).

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Disability Rating Scale (DRS)	1 units on a scale Standard Deviation 1.3	1.4 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: At 12 weeks

This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.

Scores range from 0 (normal) and 29 (extreme vegetative state).

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Disability Rating Scale (DRS)	0.7 units on a scale Standard Deviation 1	0.6 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: At baseline

This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).

A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable.

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Mini Mental Status Exam (MMSE)	28.3 units on a scale Standard Deviation 1.6	27.1 units on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: At 12 weeks

This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).

A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable.

Outcome measures

Measure	Placebo Group Baseline n=6 Participants The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.	Treatment Group Baseline n=8 Participants Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
Mini Mental Status Exam (MMSE)	29.7 units on a scale Standard Deviation 0.5	29.0 units on a scale Standard Deviation 0.6

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Escitalopram

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

Vani Rao

Johns Hopkins University & school of Medicine

Phone: 410-550-2288

Email: vrao@jhmi.edu

Results disclosure agreements

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