Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00000369
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maintenance Therapies in Bipolar Disorders
Sponsor:
University of Pittsburgh
Organization:
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, he/she 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 manic/depressive 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 he/she:
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, he/she 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 manic/depressive 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 he/she:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DSIR AT-CT | None | None | View |