Maintenance Therapies in Bipolar Disorders

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00000369
First received: November 2, 1999
Last updated: June 21, 2013
Last verified: February 2008
  Purpose

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
Bipolar Disorder
Behavioral: Individual psychotherapy
Drug: Lithium carbonate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Study Start Date: June 1997
Study Completion Date: December 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

-

Patients must have:

Acute bipolar I illness and be experiencing a manic or depressed episode at the time of study entry.

-

Required:

Current treatment with lithium carbonate.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000369

Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Ellen Frank, PhD
  More Information

Publications:
Kupfer, D.J., Frank, E., Grochocinski, V.J., Luther, J.F., Houck, P.R., Swartz, H.A. and Mallinger, A.G. Stabilization in the treatment of mania, depression and mixed states. Acta Neuropsychiatrica, 12:110-114, 2000.
Lenze, E.J., Miller, M.D., Dew, M.A., Martine, L.M., Begley, A.E., Schulz, R., Frank, E. and Reynolds, C.F., III. Health measures as outcomes and predictors of response during acute treatment for late-life depression. International Journal of Geriatric Psychiatry, 16:1-7, 2001.
Craighead, W.E., Miklowitz, D.J., Vajk, F.C. and Frank, E. Psychosocial treatments for bipolar disorder. In: A Guide to Treatments that Work, edited by P.E. Nathan and J.M. Gorman, Oxford University Press, New York, NY, 240-248, 1997 .
Miklowitz, D.J. and Frank, E. New psychotherapies for bipolar disorder. In: Bipolar Disorder: Clinical Course and Outcome, edited by J. Goldberg and M. Harrow, American Psychiatric Press, Washington, D.C.,57-84, 1999.
Hlastala, S.A. and Frank, E. Biology versus environment: Stessors in the pathophysiology of bipolar disorder. In: Bipolar Disorders: Basic Mechanisms and Therapeutic Implications. J. Soares and S. Gershon (Eds.), Marcel Dekker, Inc., New York, NY, 353-372, 2000.

ClinicalTrials.gov Identifier: NCT00000369     History of Changes
Other Study ID Numbers: R37 MH29618, DSIR AT-CT
Study First Received: November 2, 1999
Last Updated: June 21, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
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

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Antidepressive Agents
Lithium Carbonate
Lithium
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antimanic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014