Trial Outcomes & Findings for FMRI Study of Brain Response Before and After Lithium Treatment in People With Bipolar Disorder (NCT NCT00596622)

NCT ID: NCT00596622

Last Updated: 2016-10-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 46 participants
• Primary outcome timeframe: Measured at Baseline and after 8 weeks of treatment
• Results posted on: 2016-10-17

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	46
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bipolar Depressed Subjects Treated With Lithium n=18 Participants 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 n=22 Participants 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 n=6 Participants 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 n=46 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 10 • n=5 Participants	34 years STANDARD_DEVIATION 11 • n=7 Participants	26 years STANDARD_DEVIATION 4 • n=5 Participants	33 years STANDARD_DEVIATION 10 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	15 Participants n=7 Participants	3 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	20 Participants n=4 Participants
Region of Enrollment United States	18 participants n=5 Participants	22 participants n=7 Participants	6 participants n=5 Participants	46 participants n=4 Participants

PRIMARY outcome

Timeframe: Measured at Baseline and after 8 weeks of treatment

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.

Outcome measures

Measure	Bipolar Depressed Participants Treated n=15 Participants 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.	Bipolar Manic Subjects Treated n=14 Participants 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	Bipolar Euthymic Subjects Treated n=4 Participants 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
17-item Hamilton Depression Rating Scale (HDRS) Baseline 17-item HDRS	20 units on a scale Standard Deviation 4	6 units on a scale Standard Deviation 3	6 units on a scale Standard Deviation 4
17-item Hamilton Depression Rating Scale (HDRS) After 8 weeks lithium treatment	2 units on a scale Standard Deviation 3	3 units on a scale Standard Deviation 2	2 units on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Gold standard scale to measure mania, Range 0 - 60; 12 - 15 mild mania; 15 - 20 moderate mania; >20 severe mania

Outcome measures

Measure	Bipolar Depressed Participants Treated n=14 Participants 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.	Bipolar Manic Subjects Treated n=15 Participants 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	Bipolar Euthymic Subjects Treated n=4 Participants 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
Young Mania Rating Scale Baseline 17-item YMRS	15 units on a scale Standard Deviation 1	3 units on a scale Standard Deviation 2	1 units on a scale Standard Deviation 1
Young Mania Rating Scale Post 8 week treatment YMRS	3 units on a scale Standard Deviation 2	2 units on a scale Standard Deviation 3	2 units on a scale Standard Deviation 3

Adverse Events

Bipolar Participants Treated

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bipolar Participants Treated n=46 participants at risk 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
Gastrointestinal disorders Increased appetite	10.9% 5/46
Nervous system disorders headaches	32.6% 15/46
Gastrointestinal disorders Drymouth	10.9% 5/46
Eye disorders blurred vision	6.5% 3/46
Nervous system disorders dizziness	10.9% 5/46
Cardiac disorders heart palpitations	10.9% 5/46
Nervous system disorders forgetfulness	6.5% 3/46
Gastrointestinal disorders bad taste	6.5% 3/46

Additional Information

Amit Anand

Indiana University School of Medicine

Phone: 3172747422

Email: aanand@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place