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Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression

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ClinicalTrials.gov Identifier: NCT00781326
Recruitment Status : Terminated (Final cost of study medication was significantly greater than initial estimate,)
First Posted : October 29, 2008
Results First Posted : September 29, 2016
Last Update Posted : September 29, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Ellen Whyte, University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Nimodipine
Drug: Placebo
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label Antidepressant
Hide Arm/Group Description 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.
Period Title: Phase I
Started 6 [1]
Completed 2
Not Completed 4
Reason Not Completed
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 Title: Phase 2
Started 0 [1]
Completed 0
Not Completed 0
[1]
Study terminated prior to enrollment into Phase II
Arm/Group Title Open Label Antidepressant
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  50.0%
>=65 years
3
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
66.2  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
5
  83.3%
Male
1
  16.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  16.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  50.0%
White
2
  33.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
Hamilton Depression Rating Scale (24 item)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 6 participants
20.5  (2.4)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 6 participants
8.3  (2.0)
[1]
Measure Description: 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.
1.Primary Outcome
Title Hamilton Depression Rating Scale (24 Item) [Phase I Primary Outcome]
Hide Description 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. We reports scores at end of Phase I for subjects completing the phase.
Time Frame End of Phase I (at 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Antidepressant
Hide Arm/Group Description:

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.

Nimodipine: Nimodipine will be initiated at one, 30-mg tablet three times a day for 1 week, increased to 2 tablets three times a day for 1 week, and then increased to three tablets three times a day for the remaining 30 weeks of the study. Participants who cannot tolerate the maximum dose of 270 mg/day will be maintained at the highest tolerable dose.

Placebo: Placebo will be given in doses matching those of nimodipine.

Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.5  (0.7)
Time Frame Phase I (at or before 24 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label Antidepressant
Hide Arm/Group Description 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.
All-Cause Mortality
Open Label Antidepressant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open Label Antidepressant
Affected / at Risk (%) # Events
Total   1/6 (16.67%)    
Psychiatric disorders   
Mania   1/6 (16.67%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open Label Antidepressant
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Study was terminated for administrative reasons at the end of Phase I (open label antidepressant treatment). No subjects entered Phase II (Nimodipine vs Placebo).
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
Publications:
Responsible Party: Ellen Whyte, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00781326     History of Changes
Other Study ID Numbers: K23MH067710-01 ( U.S. NIH Grant/Contract )
K23MH067710-01 ( U.S. NIH Grant/Contract )
DATR AK-TNGP1
First Submitted: October 27, 2008
First Posted: October 29, 2008
Results First Submitted: March 22, 2016
Results First Posted: September 29, 2016
Last Update Posted: September 29, 2016