Back to resultsThe Evaluation and Follow-up of Patients With Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Bipolar Disorder focused on measuring Life-Charting, Cerebrospinal Fluid, Diagnostic Tests, Cognitive Testing, Course of Illness, Bipolar Disorder
Eligibility 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.
Sites / Locations
- National Institute of Mental Health (NIMH)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001652
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00001652
Brief Title
The Evaluation and Follow-up of Patients With Bipolar Disorder
Official Title
The Evaluation and Naturalistic Follow-up of Patients With Bipolar Disorder
Study Type
Observational
2. Study Status
Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Life-Charting, Cerebrospinal Fluid, Diagnostic Tests, Cognitive Testing, Course of Illness, Bipolar Disorder
7. Study Design
Enrollment
150 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Institute of Mental Health (NIMH)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
3363034
Citation
Weissman MM, Leaf PJ, Tischler GL, Blazer DG, Karno M, Bruce ML, Florio LP. Affective disorders in five United States communities. Psychol Med. 1988 Feb;18(1):141-53. doi: 10.1017/s0033291700001975. Erratum In: Psychol Med 1988 Aug;18(3):following 792.
Results Reference
background
PubMed Identifier
8279933
Citation
Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.
Results Reference
background
PubMed Identifier
7402261
Citation
Insel TR, Kalin NH, Risch SC, Cohen RM, Murphy DL. Abducens palsy after lumbar puncture. N Engl J Med. 1980 Sep 18;303(12):703. doi: 10.1056/NEJM198009183031219. No abstract available.
Results Reference
background
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The Evaluation and Follow-up of Patients With Bipolar Disorder
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