Trial Outcomes & Findings for Depression, Epinephrine, and Platelet Function (NCT NCT00166114)
NCT ID: NCT00166114
Last Updated: 2015-07-23
Results Overview
Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8. The 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table: No Response = \< 25% change in Depression Rating Scale Score Partial Responder = \< 50% to \>25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score
COMPLETED
PHASE4
40 participants
Baseline, Week 8
2015-07-23
Participant Flow
Subjects recruited from Emory Psychiatry Clinic outpatient population
Participant milestones
| Measure |
Escitalopram
Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
|
Desipramine
Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
7
|
13
|
|
Overall Study
NOT COMPLETED
|
14
|
6
|
Reasons for withdrawal
| Measure |
Escitalopram
Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
|
Desipramine
Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
4
|
|
Overall Study
Adverse Event
|
2
|
1
|
Baseline Characteristics
Depression, Epinephrine, and Platelet Function
Baseline characteristics by cohort
| Measure |
Escitalopram
n=21 Participants
Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 until day 56
|
Desipramine
n=19 Participants
Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
|
Total
n=40 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
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8. The 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table: No Response = \< 25% change in Depression Rating Scale Score Partial Responder = \< 50% to \>25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score
Outcome measures
| Measure |
Escitalopram
n=7 Participants
Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
|
Desipramine
n=13 Participants
Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
|
|---|---|---|
|
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8
No or Partial Response
|
2 participants
|
4 participants
|
|
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8
Response
|
5 participants
|
9 participants
|
Adverse Events
Escitalopram
Desipramine
Serious adverse events
| Measure |
Escitalopram
n=21 participants at risk
10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
|
Desipramine
n=19 participants at risk
25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
|
|---|---|---|
|
Psychiatric disorders
Suicide gesture (superficial lacerations to wrists with a razor)
|
4.8%
1/21
|
0.00%
0/19
|
Other adverse events
| Measure |
Escitalopram
n=21 participants at risk
10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
|
Desipramine
n=19 participants at risk
25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry Mouth
|
9.5%
2/21
|
10.5%
2/19
|
|
Cardiac disorders
Orthostatic Tachycardia
|
0.00%
0/21
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/21
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/21
|
5.3%
1/19
|
|
Gastrointestinal disorders
Heartburn
|
4.8%
1/21
|
0.00%
0/19
|
|
Nervous system disorders
Headache
|
14.3%
3/21
|
15.8%
3/19
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21
|
10.5%
2/19
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/21
|
5.3%
1/19
|
|
Gastrointestinal disorders
Indigestion
|
4.8%
1/21
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Increased Liver Function Test
|
0.00%
0/21
|
5.3%
1/19
|
|
Infections and infestations
Upper Respiratory Infection
|
4.8%
1/21
|
5.3%
1/19
|
|
Nervous system disorders
Sedation
|
4.8%
1/21
|
0.00%
0/19
|
|
Nervous system disorders
Fatigue
|
9.5%
2/21
|
0.00%
0/19
|
|
Nervous system disorders
Insomnia
|
0.00%
0/21
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Weight Loss
|
0.00%
0/21
|
5.3%
1/19
|
|
Nervous system disorders
Confusion
|
4.8%
1/21
|
0.00%
0/19
|
|
Nervous system disorders
Irritability
|
4.8%
1/21
|
0.00%
0/19
|
|
Reproductive system and breast disorders
Ejaculation Disorder
|
0.00%
0/21
|
5.3%
1/19
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/21
|
5.3%
1/19
|
Additional Information
Dominique Musselman, MD, MSCR
University of Miami School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place