Bipolar DisorderPhase 3NCT00000369
Maintenance Therapies in Bipolar Disorders
A Phase 3 study testing Individual psychotherapy and Lithium carbonate in people with Bipolar Disorder, run by University of Pittsburgh.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Individual psychotherapy and Lithium carbonate
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1997to Dec 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- -
- 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.
Who cannot join
None listed.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Individual psychotherapy, Lithium carbonate
- 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
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual psychotherapyBehavioural
Lithium carbonateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startJun 1997
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Ellen Frank, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000369
- Sponsor's protocol ID
- R37MH029618
- Other IDs
- DSIR AT-CT
- Status last verified
- Feb 2008
- First submitted
- 2 Nov 1999
- Last updated
- 25 Jun 2013
- Results posted
- No
Publications
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.
PubMed 10071717Soares 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.
PubMed 10626774Soares 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.
PubMed 10963797Soares 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.
PubMed 11166959Soares 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.
PubMed 11274655Brambilla 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.
PubMed 11306247Frank 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.
PubMed 9171907Hlastala SA, Frank E, Mallinger AG, Thase ME, Ritenour AM, Kupfer DJ. Bipolar depression: an underestimated treatment challenge. Depress Anxiety. 1997;5(2):73-83.
PubMed 9262937Malkoff-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.
PubMed 9707380Frank 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.
PubMed 10609422Feske 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.
PubMed 10831476Malkoff-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.
PubMed 12027038Frank 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.
PubMed 11018230Kupfer 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.
PubMed 26975266Scholle 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.
PubMed 10941997
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapies in Bipolar Disorders
- ClinicalTrials.gov ID
- NCT00000369
- Acronym / sponsor ID
- R37MH029618
- Conditions
- Bipolar Disorder
- Keywords
- Adult, Antidepressive Agents, Bipolar Disorder, Combined Modality Therapy, Female, Human, Lithium Carbonate, Male
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jun 1997
- Study completion
- Dec 2002 (actual)
- First posted
- 3 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -
- Acute bipolar I illness and be experiencing a manic or depressed episode at the time of study entry.
- -
- Current treatment with lithium carbonate.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual psychotherapy | Behavioural | – |
| Lithium carbonate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
- Background: PubMed 10071717Soares 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.
- Background: PubMed 10626774Soares 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.
- Background: PubMed 10963797Soares 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.
- Background: PubMed 11166959Soares 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.
- Background: PubMed 11274655Soares 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.
- Background: PubMed 11306247Brambilla 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.
- Results publication: PubMed 9171907Frank 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.
- Results publication: PubMed 9262937Hlastala SA, Frank E, Mallinger AG, Thase ME, Ritenour AM, Kupfer DJ. Bipolar depression: an underestimated treatment challenge. Depress Anxiety. 1997;5(2):73-83.
- Results publication: PubMed 9707380Malkoff-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.
- Results publication: PubMed 10609422Frank 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.
- Results publication: PubMed 10831476Feske 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.
- Results publication: PubMed 12027038Malkoff-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Frank, PhD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Individual psychotherapy and Lithium carbonate in people with Bipolar Disorder, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000369, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.