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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00000369 |
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.
Condition | Intervention | Phase |
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Bipolar Disorder |
Behavioral: Individual psychotherapy Drug: Lithium carbonate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Study Start Date: | June 1997 |
Study Completion Date: | December 2002 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
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Patients must have:
Acute bipolar I illness and be experiencing a manic or depressed episode at the time of study entry.
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Required:
Current treatment with lithium carbonate.
Study ID Numbers: | R37 MH29618, DSIR AT-CT |
Study First Received: | November 2, 1999 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00000369 |
Health Authority: | United States: Federal Government |
Adult Antidepressive Agents Bipolar Disorder Combined Modality Therapy Female Human Lithium Carbonate |
Male Psychotherapy Antidepressive Agents -- *therapeutic use Bipolar Disorder -- *therapy Bipolar Disorder -- drug therapy Lithium Carbonate -- *therapeutic use |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders |
Lithium Carbonate Psychotic Disorders Lithium |
Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antipsychotic Agents Antimanic Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Central Nervous System Agents Antidepressive Agents |