This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Adjunctive Isradipine for the Treatment of Bipolar Depression (Isradipine)

This study has been terminated.
(Lack of Enrollment)
Sponsor:
Information provided by (Responsible Party):
Roy Perlis, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01784666
First received: February 4, 2013
Last updated: April 18, 2017
Last verified: April 2017
Results First Received: November 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: Isradipine
Drug: Placebo

  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
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
Isradipine-Isradipine

Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)

Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.

Placebo -> Isradipine

Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks

Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.

Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.

Placebo-Placebo

Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks

Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.


Participant Flow:   Overall Study
    Isradipine-Isradipine   Placebo -> Isradipine   Placebo-Placebo
STARTED   1   0   1 
COMPLETED   1   0   1 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Isradipine-Isradipine

Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)

Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.

Placebo -> Isradipine

Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks

Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.

Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.

Placebo-Placebo

Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks

Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.

Total Total of all reporting groups

Baseline Measures
   Isradipine-Isradipine   Placebo -> Isradipine   Placebo-Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   0   1   2 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%   0      0   0.0%      0   0.0% 
Between 18 and 65 years      1 100.0%   0      1 100.0%      2 100.0% 
>=65 years      0   0.0%   0      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 56 
 (56 to 56) 
    44 
 (44 to 44) 
 50 
 (44 to 56) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%   0      1 100.0%      1  50.0% 
Male      1 100.0%   0      0   0.0%      1  50.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   1   0   1   2 


  Outcome Measures

1.  Primary:   Change in MADRS (4 Weeks)   [ Time Frame: Baseline vs week 4 (and, for placebo nonresponders in 1st 4 weeks, week 8 vs week 4) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
The study was terminated early by the investigator because delays in study initiation and insufficient recruitment. Our statisticians have advised that this analysis is uninformative.


  More Information
  Hide More Information

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: Dr. Roy Perlis
Organization: Massachusetts General Hospital, Center for Quantitative Health
phone: 617-643-6310
e-mail: rperlis@partners.org



Responsible Party: Roy Perlis, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01784666     History of Changes
Other Study ID Numbers: 2012-P-002449/1
Study First Received: February 4, 2013
Results First Received: November 30, 2016
Last Updated: April 18, 2017