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Advancing Personalized Antidepressant Treatment Using PET/MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02623205
Recruitment Status : Completed
First Posted : December 7, 2015
Results First Posted : June 2, 2022
Last Update Posted : December 15, 2022
Sponsor:
Information provided by (Responsible Party):
Christine DeLorenzo, Stony Brook University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Escitalopram
Drug: Placebo
Enrollment 85
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description

Active Comparator: Escitalopram (Lexapro) 10mg Week 1, 20mg Weeks 2 and 3, and 30mg for Weeks 4 to 8 (or until 12 for patients close to remission)

Escitalopram: Participants randomized to the escitalopram group will be given the medication for 8 weeks, after which they will be given the option to continue for 4 more weeks if they are close to remission.

Lactose pill manufactured to mimic Escitalopram pill

Placebo: To reduce the burden of the patients on placebo, the placebo trial will have a target of 8 weeks. To provide an opportunity for placebo non-responders to receive active drug and to aid in recruitment, we will provide 8-12 weeks of selective serotonin reuptake inhibitor (SSRI) treatment to placebo non-responders.

Period Title: Overall Study
Started 42 43
Completed 38 40
Not Completed 4 3
Reason Not Completed
Lost to Follow-Up or Discontinued Intervention             4             3
Arm/Group Title Escitalopram Placebo Total
Hide Arm/Group Description

Active Comparator: Escitalopram (Lexapro) 10mg Week 1, 20mg Weeks 2 and 3, and 30mg for Weeks 4 to 8 (or until 12 for patients close to remission)

Escitalopram: Participants randomized to the escitalopram group will be given the medication for 8 weeks, after which they will be given the option to continue for 4 more weeks if they are close to remission.

Lactose pill manufactured to mimic Escitalopram pill

Placebo: To reduce the burden of the patients on placebo, the placebo trial will have a target of 8 weeks. To provide an opportunity for placebo non-responders to receive active drug and to aid in recruitment, we will provide 8-12 weeks of SSRI treatment to placebo non-responders.

Total of all reporting groups
Overall Number of Baseline Participants 42 43 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 43 participants 85 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
 100.0%
43
 100.0%
85
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 43 participants 85 participants
Female
27
  64.3%
29
  67.4%
56
  65.9%
Male
15
  35.7%
14
  32.6%
29
  34.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Categories Number Analyzed 42 participants 43 participants 85 participants
Caucasian - White
26
  61.9%
26
  60.5%
52
  61.2%
Caucasian - Non-white
2
   4.8%
1
   2.3%
3
   3.5%
African American / Black
2
   4.8%
2
   4.7%
4
   4.7%
Asian - South Asian
5
  11.9%
2
   4.7%
7
   8.2%
Asian - East Asian
3
   7.1%
4
   9.3%
7
   8.2%
Asian - Southeast Asian
0
   0.0%
1
   2.3%
1
   1.2%
Pacific Islander
0
   0.0%
1
   2.3%
1
   1.2%
Mixed
4
   9.5%
6
  14.0%
10
  11.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 43 participants 85 participants
42 43 85
Hamilton Depression Scale (HAM-D) Rating   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on Scale
Number Analyzed 42 participants 43 participants 85 participants
18.86  (5.09) 16.79  (3.84) 17.81  (4.59)
[1]
Measure Description: Hamilton Depression Scale. Scale is from 0 to 52. The higher the score on the scale, the more severe the degree of depression.
1.Primary Outcome
Title Change From Baseline in Hamilton Depression Rating Scale at 8 Weeks
Hide Description

Comparison of Hamilton Depression Rating Scale-17 score at pretreatment and post-treatment.

Minimum score 0, maximum possible score 52, with remission defined as <=7. The higher the score on the scale, the more severe the degree of depression.

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Disparity in Week 8 Number Analyzed versus Baseline Number Enrolled due to participants lost to follow up or instances of discontinued intervention (Escitalopram Group: n = 4, Placebo Group: n =3), and participants who were excluded from analysis for one of the following: Greater than 20% blood glucose change between pre-scan and post scan sampling, Diabetes, Motion Interference, & Instrument Failure (Escitalopram Group: n = 7, Placebo Group: n = 8)
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

Active Comparator: Escitalopram (Lexapro) 10mg Week 1, 20mg Weeks 2 and 3, and 30mg for Weeks 4 to 8 (or until 12 for patients close to remission)

Escitalopram: Participants randomized to the escitalopram group will be given the medication for 8 weeks, after which they will be given the option to continue for 4 more weeks if they are close to remission.

Lactose pill manufactured to mimic Escitalopram pill

Placebo: To reduce the burden of the patients on placebo, the placebo trial will have a target of 8 weeks. To provide an opportunity for placebo non-responders to receive active drug and to aid in recruitment, we will provide 8-12 weeks of SSRI treatment to placebo non-responders.

Overall Number of Participants Analyzed 31 32
Mean (Standard Deviation)
Unit of Measure: score on a scale
11.81  (7.02) 9.41  (5.66)
2.Secondary Outcome
Title Change From Baseline in Metabolic Rate of Glucose (MRGlu), Quantified Using Arterial Blood Analysis, at 8 Weeks
Hide Description Difference between MRGlu Metabolism in Right Insular Cortex before treatment (baseline) and after treatment (week 8). Details on methods and criteria used to assess brain glucose metabolism rates can be found here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8551925/
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total n = 15 excluded from analysis for the following: Greater than 20% blood glucose change between pre-scan and post scan sampling, Motion, Instrument failure. In addition, several participants in each group were lost to follow up or discontinued intervention.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

Active Comparator: Escitalopram (Lexapro) 10mg Week 1, 20mg Weeks 2 and 3, and 30mg for Weeks 4 to 8 (or until 12 for patients close to remission)

Escitalopram: Participants randomized to the escitalopram group will be given the medication for 8 weeks, after which they will be given the option to continue for 4 more weeks if they are close to remission.

Lactose pill manufactured to mimic Escitalopram pill

Placebo: To reduce the burden of the patients on placebo, the placebo trial will have a target of 8 weeks. To provide an opportunity for placebo non-responders to receive active drug and to aid in recruitment, we will provide 8-12 weeks of SSRI treatment to placebo non-responders.

Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: mg/(min*100 ml)
0.507489448  (0.102327217) 0.068629964  (0.048866182)
3.Secondary Outcome
Title Quantification of Brain MRGlu Without an Arterial Catheter by Training Simultaneous Estimation (SimE)
Hide Description Using Simultaneous Estimation, we imputed the arterial input function from a single venous sample. When we compared the resulting imputed arterial input function to the actual arterial input function collected from plasma samples, we calculated the percent difference in activity and report it here.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This measure occurred before treatment had been started, and was independent of treatment condition, therefore participants were not stratified by Arm. Once this method had been validated, we did not continue to acquire samples with arterial lines, hence why only a subset of the participants were analyzed.
Arm/Group Title Mixed
Hide Arm/Group Description:
This group consisted of both Escitalopram & Placebo treated subjects. Participants were not stratified by arm, as that is unrelated to Outcome Measure.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Percent of Activity
2.0  (7.1)
4.Secondary Outcome
Title Bias of VersaPET Scanner From Measurements Taken at the Wrist and Ankle
Hide Description Our goal was to determine the Bias of plasma radioactivity measurements taken at the ankle with a Novel Positron Emission Tomography (VersaPET) Scanner compared to radioactivity from arterial sampling taken at the wrist. Bias refers to the offset between the ground truth and estimated data. A bias of 0% is ideal.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This measure occurred before treatment had been started, and was independent of treatment condition, therefore all subjects analyzed were grouped into one mixed arm of both drug and placebo-assigned participants. This analysis required specialized equipment that wasn't always available, so only a subset of subjects participated.
Arm/Group Title Mixed
Hide Arm/Group Description:
This group consisted of both Escitalopram & Placebo treated subjects. Participants were not stratified by arm, as that is unrelated to Outcome Measure.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Percent
5
5.Secondary Outcome
Title Correlation Coefficient of VersaPET Scanner From Measurements Taken at the Wrist or Ankle
Hide Description Arterial measurements from samples taken at the wrist were compared to the values from the VersaPET scanner (at the ankle) where the correlation coefficient between the scanner and arterial sampling are being reported. Correlation coefficient ranges from -1 to 1. The closer the value is to 1, the higher the correlation or stronger the relationship.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This measure occurred before treatment had been started, and was independent of treatment condition, therefore all subjects analyzed were grouped into one mixed arm of both drug and placebo-assigned participants. This analysis required specialized equipment that wasn't always available, so only a subset of subjects participated.
Arm/Group Title Mixed
Hide Arm/Group Description:
This group consisted of both Escitalopram & Placebo treated subjects. Participants were not stratified by arm, as that is unrelated to Outcome Measure.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Correlation Coefficient
0.97
Time Frame Adverse event data were collected over a period of up to 6-weeks during the pre-treatment washout phase (when necessary), and for the complete 8-week treatment period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description

Active Comparator: Escitalopram (Lexapro) 10mg Week 1, 20mg Weeks 2 and 3, and 30mg for Weeks 4 to 8 (or until 12 for patients close to remission)

Escitalopram: Participants randomized to the escitalopram group will be given the medication for 8 weeks, after which they will be given the option to continue for 4 more weeks if they are close to remission.

Lactose pill manufactured to mimic Escitalopram pill

Placebo: To reduce the burden of the patients on placebo, the placebo trial will have a target of 8 weeks. To provide an opportunity for placebo non-responders to receive active drug and to aid in recruitment, we will provide 8-12 weeks of SSRI treatment to placebo non-responders.

All-Cause Mortality
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/43 (0.00%) 
Hide Serious Adverse Events
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/43 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/43 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathryn Hill
Organization: Department of Psychiatry, Renaissance School of Medicine at Stony Brook University
Phone: 904-252-3449
EMail: kathryn.hill@stonybrookmedicine.edu
Layout table for additonal information
Responsible Party: Christine DeLorenzo, Stony Brook University
ClinicalTrials.gov Identifier: NCT02623205    
Other Study ID Numbers: 2014-2911-F
First Submitted: December 1, 2015
First Posted: December 7, 2015
Results First Submitted: February 7, 2022
Results First Posted: June 2, 2022
Last Update Posted: December 15, 2022