Ignite Creation Date:
2024-05-05 @ 1:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000369
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-02
Brief Title:
Maintenance Therapies in Bipolar Disorders
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if adding a regimen of individualized psychotherapy can help bipolar I patients who are on lithium
While having a manic or depressed episode patients will be assigned randomly like tossing a coin to receive appropriate medication either with or without additional individual psychotherapy If a patient responds well heshe will again be assigned randomly to receive further preventative treatment in which medication will be managed either with continued medication clinic visits alone or with additional individual psychotherapy the patient may not receive the same additional treatment this time Patient response to treatment will be evaluated throughout the study If manicdepressive symptoms return at any point during the study the patient will be treated with appropriate medication and will continue the study
An individual may be eligible for this study if heshe
Has Bipolar I disorder is experiencing a manic or depressed episode at the time of study entry and is at least 18 years old
While having a manic or depressed episode patients will be assigned randomly like tossing a coin to receive appropriate medication either with or without additional individual psychotherapy If a patient responds well heshe will again be assigned randomly to receive further preventative treatment in which medication will be managed either with continued medication clinic visits alone or with additional individual psychotherapy the patient may not receive the same additional treatment this time Patient response to treatment will be evaluated throughout the study If manicdepressive symptoms return at any point during the study the patient will be treated with appropriate medication and will continue the study
An individual may be eligible for this study if heshe
Has Bipolar I disorder is experiencing a manic or depressed episode at the time of study entry and is at least 18 years old
Detailed Description:
The primary goal of this investigation is to examine the additive prophylactic potential of an individual psychotherapy based on interpersonal and social rhythm principles in bipolar I patients maintained on lithium carbonate lithium An adaptation of maintenance interpersonal psychotherapy this intervention takes into account the specific vulnerabilities symptoms and interpersonal problem areas associated with bipolar disorder
Acutely ill patients in a manic or depressed episode are randomly assigned to either individual psychotherapy or medication clinic visits in addition to appropriate pharmacotherapy lithium carbonate Patients who stabilize HRSD and Bech-Rafaelsen 7 for four weeks are then randomly assigned to preventative treatment with either individual psychotherapy or medication clinic visits in addition to pharmacotherapy Thus patients in this study receive one of four possible treatment strategies 1 preliminary phase psychotherapy followed by preventative phase psychotherapy 2 preliminary phase medication clinic visits followed by preventative phase psychotherapy 3 preliminary phase psychotherapy followed by preventative phase medication clinic visits in addition to psychotherapy or 4 preliminary phase medication clinic visits followed by preventative phase medication clinic visits in addition to psychotherapy Those patients who experience a relapse during the initial twelve weeks of the preventative phase or a recurrence after week 12 of the preventative phase are treated with appropriate pharmacotherapy and continued in psychotherapy or medication clinic visits as dictated by their original randomization assignment These patients are then followed for the remainder of what would have been their time in the protocol had they remained well
Acutely ill patients in a manic or depressed episode are randomly assigned to either individual psychotherapy or medication clinic visits in addition to appropriate pharmacotherapy lithium carbonate Patients who stabilize HRSD and Bech-Rafaelsen 7 for four weeks are then randomly assigned to preventative treatment with either individual psychotherapy or medication clinic visits in addition to pharmacotherapy Thus patients in this study receive one of four possible treatment strategies 1 preliminary phase psychotherapy followed by preventative phase psychotherapy 2 preliminary phase medication clinic visits followed by preventative phase psychotherapy 3 preliminary phase psychotherapy followed by preventative phase medication clinic visits in addition to psychotherapy or 4 preliminary phase medication clinic visits followed by preventative phase medication clinic visits in addition to psychotherapy Those patients who experience a relapse during the initial twelve weeks of the preventative phase or a recurrence after week 12 of the preventative phase are treated with appropriate pharmacotherapy and continued in psychotherapy or medication clinic visits as dictated by their original randomization assignment These patients are then followed for the remainder of what would have been their time in the protocol had they remained well
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR AT-CT | None | None | None |