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| ID | Type | Description | Link |
|---|---|---|---|
| MH084831 | Other Grant/Funding Number | NIMH |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This proposed study is designed to compare the efficacy of interpersonal and social rhythm therapy (IPSRT) alone to IPSRT plus medication as an acute treatment for bipolar II depression. The investigators propose to conduct a randomized, controlled, trial comparing the effects of IPSRT plus pill placebo to IPSRT plus quetiapine on depressive symptoms in individuals suffering from Bipolar II depression. The investigators will also examine the impact of treatment on psychosocial function.
Specifically, we will enroll 160 individuals meeting DSM-IV criteria for BP II disorder, currently depressed, and randomly assign them to 20 weeks of treatment with IPSRT plus placebo (IPSRT-PLA) (N=80) or IPSRT plus quetiapine (IPSRT-QUE) (N=80). We will evaluate potential moderators of response to treatment including circadian phase preference, intercurrent hypomanic symptoms during the index depressive episode, clinical and demographic factors (i.e, number of previous episodes, family history of mood disorders), and prior treatment response to antidepressant medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA. |
|
| IPSRT plus quetiapine | Experimental | Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPSRT plus placebo (IPSRT-PLA) | Drug | Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment. The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo). Medication Dosing The research pharmacy will dispense medication in the following unit-dose packs: Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA) |
| Measure | Description | Time Frame |
|---|---|---|
| Remission | Number of Remitted Participants (defined as 3 consecutive weeks with HRSD-17≤8 and YMRS≤8) | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)-Short Form | Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ-SF; Total Scores) describes difference in Quality of Life Scores from Baseline to Week 20; The QLESQ-SF is a self-report measure of life satisfaction, with 16 items rated from 1 (very poor) to 5 (very good) to produce a score from 0 to 80 with higher scores indicating better quality of life. In this report, we record change in scores from baseline to follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Swartz, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41037752 | Derived | Bailey BC, Early TJ, Williams-Sites KE, Dyson B, Swartz HA. Effects of Interpersonal and Social Rhythm Therapy on Suicidal Ideation in Adults With Bipolar II Depression. J Clin Psychiatry. 2025 Sep 29;86(4):24m15768. doi: 10.4088/JCP.24m15768. | |
| 28703949 | Derived | Swartz HA, Rucci P, Thase ME, Wallace M, Carretta E, Celedonia KL, Frank E. Psychotherapy Alone and Combined With Medication as Treatments for Bipolar II Depression: A Randomized Controlled Trial. J Clin Psychiatry. 2018 Mar/Apr;79(2):16m11027. doi: 10.4088/JCP.16m11027. |
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Participants who met eligibility criteria but were on psychotropic medications at time of informed consent were gradually tapered off medications and re-evaluated to ensure that they still met eligibility criteria following one week off of all medications prior to randomization
adult outpatients with BD II depression recruited from provider referrals, advertisements, and research registries from 2010-1015
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA. IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment. The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo). Medication Dosing The research pharmacy will dispense medication in the following unit-dose packs: Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA) |
| FG001 | IPSRT Plus Quetiapine | Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE. IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment. The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo). Medication Dosing The research pharmacy will dispense medication in the following unit-dose packs: Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA. IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment. The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo). Medication Dosing The research pharmacy will dispense medication in the following unit-dose packs: Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Remission | Number of Remitted Participants (defined as 3 consecutive weeks with HRSD-17≤8 and YMRS≤8) | Intent to treat; patients were assessed weekly | Posted | Count of Participants | Participants | 20 weeks |
|
20 weeks
Side effects were measured weekly with the Patient Rated Inventory of Side Effects (PRISE), a standardized rating measure of somatic symptoms. Denominators reflect the sample for which the relevant side effect or SAE was measured. SAEs were collected for the total sample; side effects/OAEs were available for a subset of the total sample.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA. IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment. The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo). Medication Dosing The research pharmacy will dispense medication in the following unit-dose packs: Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Early Weight Gain | General disorders | P | Systematic Assessment | (>5% in first month) |
Limitations include absence of an inactive psychotherapy comparator, high dropouts, and poor remission rates. Power limitations could potentially leading to Type II errors.Our sample was predominantly white which may limit generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly A. Swartz M.D. | University of Pittsburgh School of Medicine | 412-246-5588 | swartzha@upmc.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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|
|
| IPSRT plus quetiapine | Drug | Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment. The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo). Medication Dosing The research pharmacy will dispense medication in the following unit-dose packs: Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA) |
|
|
| 20 weeks |
| preferred other treatment |
|
| Protocol Violation |
|
| Refused participation |
|
| BG001 | IPSRT Plus Quetiapine | Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE. IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment. The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo). Medication Dosing The research pharmacy will dispense medication in the following unit-dose packs: Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo | Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA. IPSRT plus placebo (IPSRT-PLA): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment. The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo). Medication Dosing The research pharmacy will dispense medication in the following unit-dose packs: Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA) |
|
|
|
| Secondary | Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)-Short Form | Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ-SF; Total Scores) describes difference in Quality of Life Scores from Baseline to Week 20; The QLESQ-SF is a self-report measure of life satisfaction, with 16 items rated from 1 (very poor) to 5 (very good) to produce a score from 0 to 80 with higher scores indicating better quality of life. In this report, we record change in scores from baseline to follow up | Analyzed data from participants for whom values were available both at baseline and at twenty weeks | Posted | Mean | Standard Deviation | units on a scale | 20 weeks |
|
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 35 |
| 44 |
| EG001 | IPSRT Plus Quetiapine | Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE. IPSRT plus quetiapine: Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment. The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo). Medication Dosing The research pharmacy will dispense medication in the following unit-dose packs: Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA) | 0 | 47 | 0 | 47 | 44 | 44 |
| Oversedation | General disorders | Systematic Assessment | over-sedation variable was created by combining 3 items from the PRISE (sleeping too much, fatigue, and decreased energy). |
|
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| D001519 |
| Behavior |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |