Trial Outcomes & Findings for Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment (NCT NCT00456014)
NCT ID: NCT00456014
Last Updated: 2019-03-19
Results Overview
Remission in this study is defined as both a ≥50% decrease in the 24-item Hamilton Depression Rating Scale (HDRS) Score and a final 24-item HDRS score \<10. Remission of depressive symptoms was calculated for the 28 completers of the SSRI phase.
COMPLETED
NA
37 participants
Measured at Week 8
2019-03-19
Participant Flow
From September 2006 to May 2012, participants were recruited through online or print advertisements, and through referrals from neighboring outpatient clinics.
MDD subjects who were currently on ineffective medication trial only enrolled if they were able to tolerate a medication washout.
Participant milestones
| Measure |
Open Standardized Treatment
Participants will take escitalopram through standardized dosing over an 8 week trial. Non-remitters will be offered entry into a second open treatment phase with standardized treatment with desipramine.
In phase 1, participants will receive escitalopram beginning at 10mg daily for 4 weeks, increasing to 20mg if non-response at week 4 or 6. If participants experience intolerable side-effects, they will be switched to an alternative SSRI, sertraline. Non-remitters after 8 weeks may enter a second phase of standardized treatment, switching from escitalopram to desipramine, dosed by blood level according to a treatment protocol. Those with intolerable side-effects to desipramine will be switched to an alternative tricyclic antidepressant, nortriptyline.
|
|---|---|
|
SSRI Phase
STARTED
|
37
|
|
SSRI Phase
COMPLETED
|
28
|
|
SSRI Phase
NOT COMPLETED
|
9
|
|
Tricyclic Phase
STARTED
|
4
|
|
Tricyclic Phase
COMPLETED
|
1
|
|
Tricyclic Phase
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment
Baseline characteristics by cohort
| Measure |
SSRI
n=37 Participants
The single arm of this study involves patients with current MDD who will all receive open standardized treatment with escitalopram. There are not multiple arms nor multiple patient groups.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
37.35 years
STANDARD_DEVIATION 13.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Week 8Population: 28 of 38 participants completed the SSRI phase. Only those 28 participants were assessed for remission status. 1 participant who is counted as a non-remitter had a spontaneous remission following his MRI.
Remission in this study is defined as both a ≥50% decrease in the 24-item Hamilton Depression Rating Scale (HDRS) Score and a final 24-item HDRS score \<10. Remission of depressive symptoms was calculated for the 28 completers of the SSRI phase.
Outcome measures
| Measure |
1 - SSRI
n=28 Participants
Participants will take escitalopram.
|
|---|---|
|
Remission of Depressive Symptoms
Participants achieving remission
|
14 participants
|
|
Remission of Depressive Symptoms
Participants failing to achieve remission
|
14 participants
|
SECONDARY outcome
Timeframe: Measured over 8 weeksPopulation: Depressed participants who did not remit during the SSRI phase advanced to the tricyclic phase of the study. Five participants started treatment with desipramine, one of which also had a trial with nortriptyline. Two participants started tricyclic treatment with nortriptyline.
Participants who did not achieve remission during the SSRI phase advanced to the tricyclic phase of the study. Participants were treated with either desipramine or nortriptyline. Seven participants started the tricyclic phase. Four completed the tricyclic phase. The completers (n=4) were analyzed for remission status.
Outcome measures
| Measure |
1 - SSRI
n=4 Participants
Participants will take escitalopram.
|
|---|---|
|
Remission of Depressive Symptoms - Tricyclic Phase
Number Achieving Remission
|
1 participants
|
|
Remission of Depressive Symptoms - Tricyclic Phase
Numbering Failing to Remit
|
3 participants
|
SECONDARY outcome
Timeframe: Measured at Week 8Population: Percent improvement of depressive symptoms was calculated for the 28 completers of the SSRI phase. 25 of the 28 SSRI participants completed a trial of escitalopram. 3 of 28 SSRI participants had intolerable side-effects to escitalopram, and were therefore switched to sertraline, and completed a trial of sertraline instead.
Mean % improvement from baseline to end of treatment trial using the 24-item Hamilton Depression Rating Scale. Percent improvement of depressive symptoms was calculated for the 28 completers of the SSRI phase. The higher the score on the 24-item HDRS, the greater the depression severity. Minimum score on the scale is 0, and maximum score is 74. Subscales are not used for this analysis.
Outcome measures
| Measure |
1 - SSRI
n=28 Participants
Participants will take escitalopram.
|
|---|---|
|
Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase
Escitalopram Improvement
|
45.46 % improvement in depression symptoms
Standard Deviation 55.95
|
|
Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase
Sertraline Improvement
|
30.01 % improvement in depression symptoms
Standard Deviation 21.87
|
Adverse Events
1 - SSRI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ramin V. Parsey, MD, PhD
Stony Brook University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place