|
|
View Clinical Trial (Medical Research Study)
|
Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder - NCT00667745-15213 (Clinical Trial 217920)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy217920.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Pittsburgh |
|
State:
|
|
PA |
| Zip Code: |
|
15213 |
| Conditions: |
|
Bipolar Disorder |
| Purpose: |
|
This study will evaluate whether lithium included as part of optimized medication treatment
improves overall level of illness, symptoms of mania and depression, and quality of life in
people with bipolar disorder.
|
| Study summary: |
|
Bipolar illness, a brain disorder that causes dramatic changes in a person's mood and
energy, affects about 2.6% of adults in the United States. Bipolar disorder is characterized
by cyclical periods of extreme highs and lows, known as episodes of mania and depression. A
person undergoing an episode of mania often experiences euphoric moods, increased energy,
and aggressive behaviors, while a person in a depressed state often experiences low moods,
lack of energy, and feelings of sadness. Lithium is a widely used mood stabilizing
medication that has been shown to reduce the occurrence and intensity of manic episodes and
may lessen depressive episodes as well. Including lithium as a part of a personalized
medication treatment approach may be the most effective means of improving symptoms of
bipolar disorder. This study will evaluate whether lithium included as part of optimized
medication treatment improves overall level of illness, symptoms of mania and depression,
and quality of life in people with bipolar disorder.
Participation in this study will last 6 months. All participants will first undergo initial
assessments that will include an interview and questionnaires to confirm a diagnosis of
bipolar disorder, vital sign measurements, a blood draw, and if female, a pregnancy test.
Eligible participants will then be assigned randomly to receive either optimized medication
plus lithium or optimized medication without lithium. Participants in both groups will
undergo 6 months of monitored treatment with their medication regimens, as prescribed by
their study doctor. Participants will attend study visits every 2 weeks for the first 8
weeks and then once a month for 4 more months. These visits will last between 45 and 60
minutes and will include medication adjustments and questions about symptoms, side effects,
and quality of life. |
| Criteria: |
|
Inclusion Criteria:
- Meets DSM-IV Criteria for bipolar disorder (type I or II)
- Currently symptomatic, as defined as a Clinical Global Impressions Scale-Bipolar
Version, Overall Severity Index (CGI-BP-S) of greater than or equal to 3
- If taking or has taken lithium, must be off lithium for at least 30 days before study
entry
- If a woman of child bearing potential, agrees to inform their doctor at the earliest
possible time of their plans to conceive, to use adequate contraception (e.g. oral
contraceptives, intrauterine device, barrier methods, total abstinence from
intercourse), and to acknowledge the risks of lithium to the fetus and infant (Depo
Provera is acceptable if it is started 3 months before study entry)
Exclusion Criteria:
- Renal impairment (serum creatinine greater than 1.5 mg/dL)
- Thyroid stimulating hormone (TSH) over 20% above the upper normal limit (participants
maintained on thyroid medication must be euthyroid for at least 3 months before Visit
1)
- History of lithium toxicity that was not caused by mismanagement or overdose
- Other contraindication to lithium (e.g., hypersensitivity to lithium or any component
of the formulation, severe cardiovascular or renal disease, severe debilitation,
dehydration, sodium depletion, pregnancy)
- Currently in crisis such that inpatient hospitalization or other crisis -
Participated in a clinical trial of an investigational drug within the 1 months
before study entry
- Pregnant or breastfeeding |
|
|
|
| Study is available at: |
|
University of Pittsburgh Medical Center
Pittsburgh, PA 15213
United States
Primary Contact:
Luann Shutt
Email: shuttls@upmc.edu
Phone: 412-246-5762
Secondary Contact:
Louisa G. Sylvia, PhD
Email: lsylvia2@partners.org
Phone: 617-643-4804 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|