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Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression

This study has been terminated.
(Final cost of study medication was significantly greater than initial estimate,)
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Ellen Whyte, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00781326
First received: October 27, 2008
Last updated: August 5, 2016
Last verified: August 2016
Results First Received: March 22, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Nimodipine
Drug: Placebo

  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
Open Label Antidepressant In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.

Participant Flow for 2 periods

Period 1:   Phase I
    Open Label Antidepressant
STARTED   6 [1] 
COMPLETED   2 
NOT COMPLETED   4 
Adverse Event                1 
Withdrawal by Subject                1 
Physician Decision                2 
[1] Nine subjects consented; 3 did not meet eligibility criteria. 6 started antidepressant treatment.

Period 2:   Phase 2
    Open Label Antidepressant
STARTED   0 [1] 
COMPLETED   0 
NOT COMPLETED   0 
[1] Study terminated prior to enrollment into Phase II



  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
Open Label Antidepressant In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.

Baseline Measures
   Open Label Antidepressant 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   3 
>=65 years   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.2  (8.7) 
Gender 
[Units: Participants]
 
Female   5 
Male   1 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   3 
White   2 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   6 
Hamilton Depression Rating Scale (24 item) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 20.5  (2.4) 
[1] Hamilton Depression Rating Scale (24 item) measures symptoms of major depression. We report total score which is the sum of all items. Total score range is 0 to 76 with higher scores indicating more severe depression.
Cumulative Illness Rating Scale (Geriatric) total [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 8.3  (2.0) 
[1] Cumulative Illness Rating Scale (Geriatric Version) is a measure of medical illness burden across 14 body systems. For the purposes of this study, we do not include the “psychiatric body system”. Within each body system, the burden of medical illness is scored 0 – 4. The total score reported here is the sum of medical burden scores across 13 body systems. Total score range is 0 to 52 with higher scores indicating greater overall burden of medical illness.


  Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale (24 Item) [Phase I Primary Outcome]   [ Time Frame: End of Phase I (at 24 weeks) ]


  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 terminated for administrative reasons at the end of Phase I (open label antidepressant treatment). No subjects entered Phase II (Nimodipine vs Placebo).


  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: Ellen Whyte, MD
Organization: University of Pittsburgh
phone: 412 246 5066
e-mail: whyteem@upmc.edu


Publications:


Responsible Party: Ellen Whyte, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00781326     History of Changes
Other Study ID Numbers: K23MH067710-01 ( US NIH Grant/Contract Award Number )
DATR AK-TNGP1
Study First Received: October 27, 2008
Results First Received: March 22, 2016
Last Updated: August 5, 2016
Health Authority: United States: Federal Government