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Effects of Cerebral Hypoperfusion and Its Reversal on Late-Life Depression

This study has been terminated.
(Enrollment difficulties)
Sponsor:
Information provided by (Responsible Party):
Warren Taylor, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01794455
First received: February 12, 2013
Last updated: August 26, 2016
Last verified: August 2016
Results First Received: July 18, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Depression
Hypertension
Interventions: Drug: Sertraline
Drug: Candesartan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Phase 1: Sertraline

Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.

Sertraline: 50mg - 200mg daily

Phase 2: Candesartan

For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.

Candesartan: 4mg - 32mg daily


Participant Flow:   Overall Study
    Phase 1: Sertraline   Phase 2: Candesartan
STARTED   0   1 
COMPLETED   0   1 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
Phase 1: Sertraline

Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.

Sertraline: 50mg - 200mg daily

Phase 2: Candesartan

For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.

Candesartan: 4mg - 32mg daily

Total Total of all reporting groups

Baseline Measures
   Phase 1: Sertraline   Phase 2: Candesartan   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   1   1 
Age 
[Units: Participants]
     
<=18 years      0   0 
Between 18 and 65 years      0   0 
>=65 years      1   1 
Age 
[Units: Years]
Mean (Full Range)
    67 
 (67 to 67) 
 67 
 (67 to 67) 
Gender 
[Units: Participants]
     
Female      0   0 
Male      1   1 
Region of Enrollment 
[Units: Participants]
     
United States      1   1 


  Outcome Measures
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1.  Primary:   MRI Arterial Spin Labeling   [ Time Frame: Change in perfusion from baseline to week 8 ]

2.  Primary:   Montgomery Asberg Depression Rating Scale (MADRS)   [ Time Frame: Week 8 ]

3.  Secondary:   Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)   [ Time Frame: Week 8 ]

4.  Secondary:   Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)   [ Time Frame: Week 20 ]

5.  Secondary:   Montgomery-Asberg Depression Rating Scale   [ Time Frame: Week 20 ]

6.  Secondary:   MRI Arterial Spin Labeling   [ Time Frame: Change from week 8 to week 20 ]


  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
Study was ended early due to difficulty with subject recruitment. MRI data could not be obtained on that one individual due to MRI contraindications.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Warren Taylor
Organization: Vanderbilt University
phone: 615-936-3555
e-mail: warren.d.taylor@vanderbilt.edu



Responsible Party: Warren Taylor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01794455     History of Changes
Other Study ID Numbers: VR5642
Study First Received: February 12, 2013
Results First Received: July 18, 2016
Last Updated: August 26, 2016
Health Authority: United States: Food and Drug Administration