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Trial record 41 of 1053 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

Pre-Treatment Positron Emission Topography Scanning for Increasing Success in Antidepressant Treatment

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ClinicalTrials.gov Identifier: NCT00456014
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : June 14, 2017
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jeffrey Miller, New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Escitalopram
Drug: Desipramine
Enrollment 37
Recruitment Details From September 2006 to May 2012, participants were recruited through online or print advertisements, and through referrals from neighboring outpatient clinics.
Pre-assignment Details MDD subjects who were currently on ineffective medication trial only enrolled if they were able to tolerate a medication washout.
Arm/Group Title Open Standardized Treatment
Hide Arm/Group Description

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.

Period Title: SSRI Phase
Started 37
Completed 28
Not Completed 9
Period Title: Tricyclic Phase
Started 4 [1]
Completed 1
Not Completed 3
[1]
Only non-remitters from phase 1 were eligible for phase 2, and not all those eligible continued.
Arm/Group Title SSRI
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
6 subjects who started on a TCA were also enrolled in the SSRI group (switched groups due to non-remission or side effects). We analyzed data from subjects completing either 6 or 8 weeks of SSRI treatment. Reasons remaining subjects were dropped from analysis included early withdrawal, insufficient PET data and later determination of ineligibility.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
  97.3%
>=65 years
1
   2.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
37.35  (13.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
22
  59.5%
Male
15
  40.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants
37
1.Primary Outcome
Title Remission of Depressive Symptoms
Hide Description 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.
Time Frame Measured at Week 8
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title 1 - SSRI
Hide Arm/Group Description:
Participants will take escitalopram.
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
Participants achieving remission 14
Participants failing to achieve remission 14
2.Secondary Outcome
Title Remission of Depressive Symptoms - Tricyclic Phase
Hide Description 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.
Time Frame Measured over 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tricyclic Group
Hide Arm/Group Description:
7 participants who did not remit during the SSRI phase advanced to the tricyclic phase. 4 participants completed this phase.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
Number Achieving Remission 1
Numbering Failing to Remit 3
3.Secondary Outcome
Title Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase
Hide Description 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.
Time Frame Measured at Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1 - SSRI
Hide Arm/Group Description:
Participants will complete an 8-week trial of the SSRI escitalopram, or, if not tolerated, an 8-week trial of the SSRI sertraline.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: % improvement in depression symptoms
Escitalopram Improvement Number Analyzed 28 participants
45.46  (55.95)
Sertraline Improvement Number Analyzed 3 participants
30.01  (21.87)
Time Frame [Not Specified]
Adverse Event Reporting Description Systematic assessment included structured assessment using clinical global impression (CGI) therapeutic effects item at each treatment visit as well as questions regarding tolerability and side-effects of treatment intervention at each treatment visit.
 
Arm/Group Title 1 - SSRI
Hide Arm/Group Description Participants will take escitalopram.
All-Cause Mortality
1 - SSRI
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1 - SSRI
Affected / at Risk (%)
Total   0/37 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 - SSRI
Affected / at Risk (%)
Total   0/37 (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
Name/Title: Ramin V. Parsey, MD, PhD
Organization: Stony Brook University School of Medicine
Phone: 631-444-3084
Responsible Party: Jeffrey Miller, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00456014     History of Changes
Other Study ID Numbers: #6351R (formerly 5206)
R01MH074813 ( U.S. NIH Grant/Contract )
DATR A3-NSS
First Submitted: April 2, 2007
First Posted: April 4, 2007
Results First Submitted: November 26, 2014
Results First Posted: June 14, 2017
Last Update Posted: March 19, 2019