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

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ClinicalTrials.gov Identifier: NCT00596622
Recruitment Status : Completed
First Posted : January 17, 2008
Results First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Indiana University

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
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bipolar Subjects Who Were Included in Lithium Treatment Arm
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 46
Completed 33
Not Completed 13
Arm/Group Title Bipolar Depressed Subjects Treated With Lithium Bipolar Manic Subjects Treated With Lithium Bipolar Euthymic Subjects Treated With Lithium Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 18 22 6 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 22 participants 6 participants 46 participants
34  (10) 34  (11) 26  (4) 33  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 22 participants 6 participants 46 participants
Female
8
  44.4%
15
  68.2%
3
  50.0%
26
  56.5%
Male
10
  55.6%
7
  31.8%
3
  50.0%
20
  43.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 22 participants 6 participants 46 participants
18 22 6 46
1.Primary Outcome
Title 17-item Hamilton Depression Rating Scale (HDRS)
Hide Description 17-item HDRS is gold standard for measurement of depression with a range from 0 - 52. 10 - 14: mild depression; 14-20 moderate depression; >20: severe and very severe depression.
Time Frame Measured at Baseline and after 8 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bipolar Depressed Participants Treated Bipolar Manic Subjects Treated Bipolar Euthymic Subjects Treated
Hide Arm/Group Description:

Participants with bipolar depression 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.

Participants with bipolar mania 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

Participants with bipolar euthymia 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

Overall Number of Participants Analyzed 15 14 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 17-item HDRS 20  (4) 6  (3) 6  (4)
After 8 weeks lithium treatment 2  (3) 3  (2) 2  (3)
2.Secondary Outcome
Title Young Mania Rating Scale
Hide Description Gold standard scale to measure mania, Range 0 - 60; 12 - 15 mild mania; 15 - 20 moderate mania; >20 severe mania
Time Frame Baseline and 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bipolar Manic Subjects Treated Bipolar Depressed Subjects Treated Bipolar Euthymic Subjects Treated
Hide Arm/Group Description:

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.

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.

Bipolar euthymia picture response 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.

Overall Number of Participants Analyzed 14 15 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 17-item YMRS 15  (1) 3  (2) 1  (1)
Post 8 week treatment YMRS 3  (2) 2  (3) 2  (3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bipolar Participants Treated
Hide Arm/Group Description

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.

Adverse Events information was collected irrespective of the sub-grouping

All-Cause Mortality
Bipolar Participants Treated
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bipolar Participants Treated
Affected / at Risk (%)
Total   0/46 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bipolar Participants Treated
Affected / at Risk (%)
Total   40/46 (86.96%) 
Cardiac disorders   
heart palpitations *  5/46 (10.87%) 
Eye disorders   
blurred vision *  3/46 (6.52%) 
Gastrointestinal disorders   
Increased appetite *  5/46 (10.87%) 
Drymouth *  5/46 (10.87%) 
bad taste *  3/46 (6.52%) 
Nervous system disorders   
headaches *  15/46 (32.61%) 
dizziness *  5/46 (10.87%) 
forgetfulness *  3/46 (6.52%) 
*
Indicates events were collected by non-systematic assessment
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
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 )
R01MH075025 ( U.S. NIH Grant/Contract )
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