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Maintenance Therapies in Bipolar Disorders
This study has been completed.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00000369
  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 III

MedlinePlus related topics: Antidepressants Bipolar Disorder
Drug Information available for: Lithium carbonate Lithium citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized

Further study details as provided by National Institute of Mental Health (NIMH):

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

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

Publications of Results:
Frank E, Hlastala S, Ritenour A, Houck P, Tu XM, Monk TH, Mallinger AG, Kupfer DJ. Inducing lifestyle regularity in recovering bipolar disorder patients: results from the maintenance therapies in bipolar disorder protocol. Biol Psychiatry. 1997 Jun 15;41(12):1165-73.
Hlastala SA, Frank E, Mallinger AG, Thase ME, Ritenour AM, Kupfer DJ. Bipolar depression: an underestimated treatment challenge. Depress Anxiety. 1997;5(2):73-83.
Malkoff-Schwartz S, Frank E, Anderson B, Sherrill JT, Siegel L, Patterson D, Kupfer DJ. Stressful life events and social rhythm disruption in the onset of manic and depressive bipolar episodes: a preliminary investigation. Arch Gen Psychiatry. 1998 Aug;55(8):702-7.
Frank E, Swartz HA, Mallinger AG, Thase ME, Weaver EV, Kupfer DJ. Adjunctive psychotherapy for bipolar disorder: effects of changing treatment modality. J Abnorm Psychol. 1999 Nov;108(4):579-87.
Feske U, Frank E, Mallinger AG, Houck PR, Fagiolini A, Shear MK, Grochocinski VJ, Kupfer DJ. Anxiety as a correlate of response to the acute treatment of bipolar I disorder. Am J Psychiatry. 2000 Jun;157(6):956-62.
Malkoff-Schwartz S, Frank E, Anderson BP, Hlastala SA, Luther JF, Sherrill JT, Houck PR, Kupfer DJ. Social rhythm disruption and stressful life events in the onset of bipolar and unipolar episodes. Psychol Med. 2000 Sep;30(5):1005-16.
Frank E, Swartz HA, Kupfer DJ. Interpersonal and social rhythm therapy: managing the chaos of bipolar disorder. Biol Psychiatry. 2000 Sep 15;48(6):593-604. Review.
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.
Scholle SH, Peele PB, Kelleher KJ, Frank E, Jansen-McWilliams L, Kupfer D. Effect of different recruitment sources on the composition of a bipolar disorder case registry. Soc Psychiatry Psychiatr Epidemiol. 2000 May;35(5):220-7.
Hlastala SA, Frank E, Kowalski J, Sherrill JT, Tu XM, Anderson B, Kupfer DJ. Stressful life events, bipolar disorder, and the "kindling model". J Abnorm Psychol. 2000 Nov;109(4):777-86.
Swartz HA, Frank E. Psychotherapy for bipolar depression: a phase-specific treatment strategy? Bipolar Disord. 2001 Feb;3(1):11-22. Review.
Sassi RB, Nicoletti M, Brambilla P, Harenski K, Mallinger AG, Frank E, Kupfer DJ, Keshavan MS, Soares JC. Decreased pituitary volume in patients with bipolar disorder. Biol Psychiatry. 2001 Aug 15;50(4):271-80.
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.
Fagiolini A, Buysse DJ, Frank E, Houck PR, Luther JF, Kupfer DJ. Tolerability of combined treatment with lithium and paroxetine in patients with bipolar disorder and depression. J Clin Psychopharmacol. 2001 Oct;21(5):474-8.
Kupfer DJ, Frank E, Grochocinski VJ, Cluss PA, Houck PR, Stapf DA. Demographic and clinical characteristics of individuals in a bipolar disorder case registry. J Clin Psychiatry. 2002 Feb;63(2):120-5.
Cole DP, Thase ME, Mallinger AG, Soares JC, Luther JF, Kupfer DJ, Frank E. Slower treatment response in bipolar depression predicted by lower pretreatment thyroid function. Am J Psychiatry. 2002 Jan;159(1):116-21.
Miklowitz DJ, Frank E, George EL. New psychosocial treatments for the outpatient management of bipolar disorder. Psychopharmacol Bull. 1996;32(4):613-21.
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.
Frank E, Kupfer DJ, Thase ME, Mallinger AG, Swartz HA, Fagiolini AM, Grochocinski V, Houck P, Scott J, Thompson W, Monk T. Two-year outcomes for interpersonal and social rhythm therapy in individuals with bipolar I disorder. Arch Gen Psychiatry. 2005 Sep;62(9):996-1004.

Other Publications:
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

Keywords provided by National Institute of Mental Health (NIMH):
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

Study placed in the following topic categories:
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Lithium Carbonate
Psychotic Disorders
Lithium

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 15, 2009