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Home > "T" Clinical Trials Conditions > The Evaluation and Follow-up of Patients with Bipolar Disorder  The Evaluation and Follow-up of Patients with Bipolar Disorder
The Evaluation and Follow-up of Patients with Bipolar Disorder
For Condition: Bipolar Disorder
Status: Completed
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this research protocol is to screen and enroll individuals who have bipolar disorder and to track each person's course of illness in order to study the long-term course of illness and to elucidate possible clinical and biological predictors of acute and sustained treatment response. As a part of this protocol, subjects will: systematically be administered psychiatric rating scales such as the life-chart method (LCM) for daily assessment of mood, sleep, and behavior; be asked to participate in non-invasive research procedures, such as blood drawing for measurement of thyroid antibodies and intracellular calcium; and be medicated as is clinically appropriate. This protocol also serves as a stepping stone to other protocols such as the comparative acute and long-term efficacy of three antidepressants (#95-M-0129), and the efficacy of omega-3 fatty acids (#00-M-0004), for which separate written informed consents are obtained. Patients in this study are participants in the larger NIMH-Stanley Foundation Bipolar Network (SFBN), which involves six academic sites focused on better understanding the long-term course and treatment of the illness. The current protocol thus serves as an entry point for individuals with bipolar disorder for screening and detailed longitudinal assessment both prior to and in between more formal blind randomized IRB approved treatment protocols.
Details: The purpose of this research protocol is to screen and enroll individuals who have bipolar disorder and to track each person's course of illness in order to study the long-term course of illness and to elucidate possible clinical and biological predictors of acute and sustained treatment response. As a part of this protocol, subjects will: systematically be administered psychiatric rating scales such as the life-chart method (LCM) for daily assessment of mood, sleep, and behavior; be asked to participate in non-invasive research procedures, such as blood drawing for measurement of thyroid antibodies and intracellular calcium; and be medicated as is clinically appropriate. This protocol also serves as a stepping stone to other protocols such as the comparative acute and long-term efficacy of three antidepressants (#95-M-0129), and the efficacy of omega-3 fatty acids (#00-M-0004), for which separate written informed consents are obtained. Patients in this study are participants in the larger NIMH-Stanley Foundation Bipolar Network (SFBN), which involves six academic sites focused on better understanding the long-term course and treatment of the illness. The current protocol thus serves as an entry point for individuals with bipolar disorder for screening and detailed longitudinal assessment both prior to and in between more formal blind randomized IRB approved treatment protocols.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Subjects must fulfill DSM-IV criteria for Bipolar I disorder (BPI), Bipolar II disorder (BPII), Bipolar Disorder not otherwise specified (BPNOS), or schizoaffective disorder bipolar type. Subjects must be competent to comprehend the purpose of the study and to provide written informed consent and be willing to participate in detailed longitudinal follow-up. Subjects will undergo complete psychiatric diagnostic interview (SCID--DSM-IV), medical, neurological, and laboratory examinations (as appropriate such as EKG, renal and liver function tests, serum electrolytes, urinalysis, HIV, hepatitis B, pregnancy testing, and urine drug screen for the presence of psychoactive drugs and drugs of abuse). Subjects must be at least 18 years old. Subjects should have no general medical illness that is primary (i.e. appears to be causing the mood disorder), or contraindicates the use of conventional and study medications under other protocols. Women participants of child bearing potential must be nongravid, nonnursing, and using acceptable method of birth control such as intrauterine device, diaphragm with contraceptive foam, or condom with spermicide. Subjects must not have alcohol or substance use or dependence of sufficient magnitude to require independent, concurrent treatment intervention (excluding self-help groups), i.e., hospitalization, day treatment programs, or counselor visits.
Total Enrollment: 150
Location and Contact Information:
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970039; 97-M-0039
Study Start Date: December 2, 1996
Record last reviewed: December 10, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001652
Other Bipolar Disorder Studies:
1. A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder.
2. Acupuncture as a Supplemental Treatment for Bipolar Depression
3. Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder
4. Seroquel plus Mood Stabilizer Compared to Placebo plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
5. Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression
Related Studies:
Other Bipolar Disorder Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
The Evaluation and Follow-up of Patients with Bipolar Disorder
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