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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00456014
First received: April 2, 2007
Last updated: June 20, 2017
Last verified: June 2017
Results First Received: November 26, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Escitalopram
Drug: Desipramine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From September 2006 to May 2012, participants were recruited through online or print advertisements, and through referrals from neighboring outpatient clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
MDD subjects who were currently on ineffective medication trial only enrolled if they were able to tolerate a medication washout.

Reporting Groups
  Description
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.


Participant Flow for 2 periods

Period 1:   SSRI Phase
    Open Standardized Treatment
STARTED   37 
COMPLETED   28 
NOT COMPLETED   9 

Period 2:   Tricyclic Phase
    Open Standardized Treatment
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
SSRI 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.

Baseline Measures
   SSRI 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      36  97.3% 
>=65 years      1   2.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.35  (13.61) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      22  59.5% 
Male      15  40.5% 
Region of Enrollment 
[Units: Participants]
 
United States   37 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Remission of Depressive Symptoms   [ Time Frame: Measured at Week 8 ]

2.  Secondary:   Remission of Depressive Symptoms - Tricyclic Phase   [ Time Frame: Measured over 8 weeks ]

3.  Secondary:   Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase   [ Time Frame: Measured at Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small sample size, homogeneity of sample size


  More Information
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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
e-mail: Ramin.Parsey@stonybrookmedicine.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: 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
Study First Received: April 2, 2007
Results First Received: November 26, 2014
Last Updated: June 20, 2017