Maintenance Therapies in Bipolar Disorders

NCT00000369 | Completed Phase 3

• 2 other identifiers: R37MH029618DSIR AT-CT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bipolar Disorder

Keywords

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

Interventions

Individual psychotherapy BEHAVIORAL

Lithium carbonate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Related Publications (27)

• Soares JC, Mallinger AG, Dippold CS, Frank E, Kupfer DJ. Platelet membrane phospholipids in euthymic bipolar disorder patients: are they affected by lithium treatment? Biol Psychiatry. 1999 Feb 15;45(4):453-7. doi: 10.1016/s0006-3223(98)00048-1.

  PMID: 10071717 BACKGROUND

• Soares JC, Barwell M, Mallinger AG, Kupfer DJ, Frank E. Adjunctive antipsychotic use in bipolar patients: an open 6-month prospective study following an acute episode. J Affect Disord. 1999 Nov;56(1):1-8. doi: 10.1016/s0165-0327(99)00026-9.

  PMID: 10626774 BACKGROUND

• Soares JC, Chen G, Dippold CS, Wells KF, Frank E, Kupfer DJ, Manji HK, Mallinger AG. Concurrent measures of protein kinase C and phosphoinositides in lithium-treated bipolar patients and healthy individuals: a preliminary study. Psychiatry Res. 2000 Aug 21;95(2):109-18. doi: 10.1016/s0165-1781(00)00175-x.

  PMID: 10963797 BACKGROUND

• Soares JC, Dippold CS, Wells KF, Frank E, Kupfer DJ, Mallinger AG. Increased platelet membrane phosphatidylinositol-4,5-bisphosphate in drug-free depressed bipolar patients. Neurosci Lett. 2001 Feb 16;299(1-2):150-2. doi: 10.1016/s0304-3940(00)01775-4.

  PMID: 11166959 BACKGROUND

• Soares JC, Boada F, Spencer S, Mallinger AG, Dippold CS, Wells KF, Frank E, Keshavan MS, Gershon S, Kupfer DJ. Brain lithium concentrations in bipolar disorder patients: preliminary (7)Li magnetic resonance studies at 3 T. Biol Psychiatry. 2001 Mar 1;49(5):437-43. doi: 10.1016/s0006-3223(00)00985-9.

  PMID: 11274655 BACKGROUND

• Brambilla P, Harenski K, Nicoletti MA, Mallinger AG, Frank E, Kupfer DJ, Keshavan MS, Soares JC. Anatomical MRI study of basal ganglia in bipolar disorder patients. Psychiatry Res. 2001 Apr 10;106(2):65-80. doi: 10.1016/s0925-4927(01)00073-7.

  PMID: 11306247 BACKGROUND

• 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. doi: 10.1016/s0006-3223(96)00241-7.

  PMID: 9171907 RESULT

• 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.

  PMID: 9262937 RESULT

• 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. doi: 10.1001/archpsyc.55.8.702.

  PMID: 9707380 RESULT

• 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. doi: 10.1037//0021-843x.108.4.579.

  PMID: 10609422 RESULT

• 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. doi: 10.1176/appi.ajp.157.6.956.

  PMID: 10831476 RESULT

• 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. doi: 10.1017/s0033291799002706.

  PMID: 12027038 RESULT

• 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. doi: 10.1016/s0006-3223(00)00969-0.

  PMID: 11018230 RESULT

• Kupfer DJ, Frank E, Grochocinski VJ, Luther JF, Houck PR, Swartz HA, Mailinger AG. Stabilization in the treatment of mania, depression and mixed states. Acta Neuropsychiatr. 2000 Sep;12(3):110-4. doi: 10.1017/S0924270800035547.

  PMID: 26975266 RESULT

• 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. doi: 10.1007/s001270050231.

  PMID: 10941997 RESULT

• 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. doi: 10.1037//0021-843x.109.4.777.

  PMID: 11196004 RESULT

• Swartz HA, Frank E. Psychotherapy for bipolar depression: a phase-specific treatment strategy? Bipolar Disord. 2001 Feb;3(1):11-22. doi: 10.1034/j.1399-5618.2001.030102.x.

  PMID: 11256459 RESULT

• 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. doi: 10.1016/s0006-3223(01)01086-1.

  PMID: 11522262 RESULT

• Lenze EJ, Miller MD, Dew MA, Martire LM, Mulsant BH, Begley AE, Schulz R, Frank E, Reynolds CF 3rd. Subjective health measures and acute treatment outcomes in geriatric depression. Int J Geriatr Psychiatry. 2001 Dec;16(12):1149-55. doi: 10.1002/gps.503.

  PMID: 11748774 RESULT

• 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. doi: 10.1097/00004714-200110000-00003.

  PMID: 11593071 RESULT

• 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. doi: 10.4088/jcp.v63n0206.

  PMID: 11874212 RESULT

• 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. doi: 10.1176/appi.ajp.159.1.116.

  PMID: 11772699 RESULT

• Miklowitz DJ, Frank E, George EL. New psychosocial treatments for the outpatient management of bipolar disorder. Psychopharmacol Bull. 1996;32(4):613-21.

  PMID: 8993082 RESULT

• 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 .

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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. doi: 10.1001/archpsyc.62.9.996.

  PMID: 16143731 RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Study Officials

• Ellen Frank, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Start: June 1, 1997
• Study Completion: December 1, 2002
• Last Updated: June 25, 2013

Record last verified: 2008-02