A Double-Blind, Placebo Controlled Trial of Celecoxib (cox-II inhibitor) as an Adjunct in the Treatment of Bipolar I and II Patients with Depressed or Mixed Episodes

A Double-Blind, Placebo Controlled Trial of Celecoxib (cox-II inhibitor) as an Adjunct in the Treatment of Bipolar I and II Patients with Depressed or Mixed Episodes

Overview
This study is for adults diagnosed with Bipolar Type I or II and currently experiencing a recurrent depressive or mixed episode. The purpose of this study is to study the effect of celecoxib on bipolar disorder. The first part of the study is a 6-week double-blind placebo controlled trial with celecoxib as an add-on treatment to mood stabilizers in refractory bipolar type I and II subjects, on a depressive or mixed episode. Subjects will be randomly assigned to either the placebo or celecoxib treatment groups. Subjects will not know which medication they are taking. The second part of the study involves an open continuation trial using subjects that responded to celecoxib, as well as subjects taking placebo that did not respond to treatment. In this second part of the study, the subjects know they are receiving celecoxib. Any subjects who decompensate significantly or become suicidal will be taken off study medication immediately. The compensation for this study is $100 for the first phase and an additional $60 for the second phase. If the subject meets the inclusion criteria, a screening visit is scheduled. At this screening visit, approximately 3 hours long, a structured clinical interview is performed to confirm there is no psychiatric diagnosis, a physical exam is done by a medical doctor and blood and urine tests are performed to rule out medical problems and pregnancy, if applicable. You will also be seen by a study psychiatrist. If the subject continues to qualify, then he/she is randomly assigned to celecoxib or placebo. The subject is seen on Weeks 0, 1, 2, 4, and 6. During each of these visits, body weight, blood pressure, and heart rate are measured, and the subject is seen by a study psychiatrist. On week 4 a urine pregnancy test is done, if applicable. After Week 6, study participation ends for subjects who did not respond to celecoxib, as well as for subjects who responded to the placebo. For those subjects who responded to the celecoxib, as well as those who did not respond to the placebo, they are invited to participate in a 6 week open extension of the study in which all subjects receive celecoxib. Subjects are seen on Weeks 8, 10, and 12. During each of these visits, body weight, blood pressure, and heart rate are measured, and the subject is seen by a study psychiatrist. On Weeks 8 and 12 a urine pregnancy test is done, if applicable. After Week 12, study participation ends for the remainder of the subjects.

Eligibility

Diagnosed with Bipolar Type I or II and currently in a depressive or mixed episode
Co-morbid conditions and substance abuse are ok
Between the ages of 18-99
No history of sensitivity to sulfonamides
No liver, kidney, or heart disease
No prior history of kidney dysfunction or cardiac problems
No history of stomach ulcers
Not pregnant or breastfeeding

*Subjects in this study can be on medications

Study Payment

$20 per evaluation period (week 0, 1, 2, 4, 6, 8, 10, 12):

-If the subject completes the 6-week double-blind phase, he/she will receive $100

-If the subject remains in the study and completes the open extension continuation phase, he/she will receive an additional $60, for a total of $160

(Local) Study Sites:

The screening visit is scheduled at the University of Texas Health Science Center at San Antonio (UTHSCSA), and the General Clinical Research Center (GCRC) at the South Texas Veterans Healthcare System, Audie L. Murphy Division. Subsequent visits are scheduled at the GCRC.

For more information please call Rhonda Barnard at 210-562-5491.

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Overview
This study is for adults diagnosed with Bipolar Type I or II and currently experiencing a recurrent depressive or mixed episode. The purpose of this study is to study the effect of celecoxib on bipolar disorder. The first part of the study is a 6-week double-blind placebo controlled trial with celecoxib as an add-on treatment to mood stabilizers in refractory bipolar type I and II subjects, on a depressive or mixed episode. Subjects will be randomly assigned to either the placebo or celecoxib treatment groups. Subjects will not know which medication they are taking. The second part of the study involves an open continuation trial using subjects that responded to celecoxib, as well as subjects taking placebo that did not respond to treatment. In this second part of the study, the subjects know they are receiving celecoxib. Any subjects who decompensate significantly or become suicidal will be taken off study medication immediately. The compensation for this study is $100 for the first phase and an additional $60 for the second phase. If the subject meets the inclusion criteria, a screening visit is scheduled. At this screening visit, approximately 3 hours long, a structured clinical interview is performed to confirm there is no psychiatric diagnosis, a physical exam is done by a medical doctor and blood and urine tests are performed to rule out medical problems and pregnancy, if applicable. You will also be seen by a study psychiatrist. If the subject continues to qualify, then he/she is randomly assigned to celecoxib or placebo. The subject is seen on Weeks 0, 1, 2, 4, and 6. During each of these visits, body weight, blood pressure, and heart rate are measured, and the subject is seen by a study psychiatrist. On week 4 a urine pregnancy test is done, if applicable. After Week 6, study participation ends for subjects who did not respond to celecoxib, as well as for subjects who responded to the placebo. For those subjects who responded to the celecoxib, as well as those who did not respond to the placebo, they are invited to participate in a 6 week open extension of the study in which all subjects receive celecoxib. Subjects are seen on Weeks 8, 10, and 12. During each of these visits, body weight, blood pressure, and heart rate are measured, and the subject is seen by a study psychiatrist. On Weeks 8 and 12 a urine pregnancy test is done, if applicable. After Week 12, study participation ends for the remainder of the subjects.

Eligibility

Diagnosed with Bipolar Type I or II and currently in a depressive or mixed episode
Co-morbid conditions and substance abuse are ok
Between the ages of 18-99
No history of sensitivity to sulfonamides
No liver, kidney, or heart disease
No prior history of kidney dysfunction or cardiac problems
No history of stomach ulcers
Not pregnant or breastfeeding

*Subjects in this study can be on medications

Study Payment

$20 per evaluation period (week 0, 1, 2, 4, 6, 8, 10, 12):

-If the subject completes the 6-week double-blind phase, he/she will receive $100

-If the subject remains in the study and completes the open extension continuation phase, he/she will receive an additional $60, for a total of $160

(Local) Study Sites:

The screening visit is scheduled at the University of Texas Health Science Center at San Antonio (UTHSCSA), and the General Clinical Research Center (GCRC) at the South Texas Veterans Healthcare System, Audie L. Murphy Division. Subsequent visits are scheduled at the GCRC.

For more information please call Rhonda Barnard at 210-562-5491.