Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder (LiTMUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00667745
First received: April 24, 2008
Last updated: April 30, 2013
Last verified: July 2010
Results First Received: October 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: Lithium Carbonate
Drug: Optimized Treatment (OPT)

  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
OPT With Lithium

Participants received lithium plus optimized medication treatment, as needed.

Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.

Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines.

OPT Without Lithium

Participants only received optimized medication treatment, as needed; lithium was not be used.

Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines.


Participant Flow:   Overall Study
    OPT With Lithium     OPT Without Lithium  
STARTED     141     142  
COMPLETED     116     121  
NOT COMPLETED     25     21  



  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.
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Reporting Groups
  Description
OPT With Lithium

Participants received lithium plus optimized medication treatment, as needed.

Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.

Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines.

OPT Without Lithium

Participants only received optimized medication treatment, as needed; lithium was not be used.

Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines.

Total Total of all reporting groups

Baseline Measures
    OPT With Lithium     OPT Without Lithium     Total  
Number of Participants  
[units: participants]
  141     142     283  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     141     142     283  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.7  ± 11.7     39.4  ± 13.0     39.1  ± 12.3  
Gender  
[units: participants]
     
Female     77     83     160  
Male     64     59     123  
Region of Enrollment  
[units: participants]
     
United States     141     142     283  



  Outcome Measures
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1.  Primary:   Overall Change in Bipolar Illness Severity as Measured by Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Score   [ Time Frame: Relevant time points: baseline and week 24 ]

2.  Primary:   Number of Necessary Medication Adjustments   [ Time Frame: Measured over 6 months ]

3.  Secondary:   Symptoms as Measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) and the Young Mania Rating Scale (YMRS)   [ Time Frame: Measured over 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)   [ Time Frame: Measured over 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Suicidality   [ Time Frame: Measured over 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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
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  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: Dr. Andrew Nierenberg, Director of the Bipolar Trials Network
Organization: Bipolar Clinic and Research Program at
phone: 617-724-0837
e-mail: ANIERENBERG@PARTNERS.ORG


No publications provided by National Institute of Mental Health (NIMH)

Publications automatically indexed to this study:


Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00667745     History of Changes
Other Study ID Numbers: N01 MH080001-01, DSIR AT
Study First Received: April 24, 2008
Results First Received: October 25, 2012
Last Updated: April 30, 2013
Health Authority: United States: Federal Government