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FMRI Study of Brain Response Before and After Lithium Treatment in People With Bipolar Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596622
First Posted: January 17, 2008
Last Update Posted: October 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Indiana University
Results First Submitted: July 8, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Bipolar Disorder
Intervention: Drug: Lithium

  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
Bipolar Subjects Who Were Included in Lithium Treatment Arm

Participants with bipolar disorder who undergo fMRI and lithium treatment

Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.

Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks.


Participant Flow:   Overall Study
    Bipolar Subjects Who Were Included in Lithium Treatment Arm
STARTED   46 
COMPLETED   33 
NOT COMPLETED   13 



  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
Bipolar Depressed Subjects Treated With Lithium

Participants with bipolar depression picture response during fMRI before and after treatment with lithium

Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.

Depression and mania scores before and after treatment

Bipolar Manic Subjects Treated With Lithium

Participants with bipolar mania picture response during fMRI before and after treatment with lithium

Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.

Depression and mania scores before and after treatment

Bipolar Euthymic Subjects Treated With Lithium

Participants with bipolar mania picture response during fMRI before and after treatment with lithium

Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.

Depression and mania scores before and after treatment

Total Total of all reporting groups

Baseline Measures
   Bipolar Depressed Subjects Treated With Lithium   Bipolar Manic Subjects Treated With Lithium   Bipolar Euthymic Subjects Treated With Lithium   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   22   6   46 
Age 
[Units: Years]
Mean (Standard Deviation)
 34  (10)   34  (11)   26  (4)   33  (10) 
Gender 
[Units: Participants]
       
Female   8   15   3   26 
Male   10   7   3   20 
Region of Enrollment 
[Units: Participants]
       
United States   18   22   6   46 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   17-item Hamilton Depression Rating Scale (HDRS)   [ Time Frame: Measured at Baseline and after 8 weeks of treatment ]

2.  Secondary:   Young Mania Rating Scale   [ Time Frame: Baseline and 8 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
Small number of subjects


  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: Amit Anand
Organization: Indiana University School of Medicine
phone: 3172747422
e-mail: aanand@iupui.edu



Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00596622     History of Changes
Other Study ID Numbers: R01MH075025 ( U.S. NIH Grant/Contract )
0607-23 ( Other Identifier: Indiana University IRB )
DATR A3-NSS ( Other Identifier: Indiana University )
First Submitted: January 8, 2008
First Posted: January 17, 2008
Results First Submitted: July 8, 2016
Results First Posted: October 17, 2016
Last Update Posted: October 17, 2016