Trial Outcomes & Findings for Acute Psychotherapy for Bipolar II Depression (NCT NCT01133821)
NCT ID: NCT01133821
Last Updated: 2018-01-09
Results Overview
Number of Remitted Participants (defined as 3 consecutive weeks with HRSD-17≤8 and YMRS≤8)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
20 weeks
Results posted on
2018-01-09
Participant Flow
adult outpatients with BD II depression recruited from provider referrals, advertisements, and research registries from 2010-1015
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
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
11
|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
|
Overall Study
preferred other treatment
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Refused participation
|
1
|
3
|
Baseline Characteristics
Acute Psychotherapy for Bipolar II Depression
Baseline characteristics by cohort
| Measure |
IPSRT Plus Quetiapine
n=47 Participants
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)
|
Total
n=92 Participants
Total of all reporting groups
|
Placebo
n=45 Participants
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)
|
|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 10.3 • n=41 Participants
|
32.4 years
STANDARD_DEVIATION 10.8 • n=35 Participants
|
33.9 years
STANDARD_DEVIATION 11.2 • n=39 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=41 Participants
|
58 Participants
n=35 Participants
|
26 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
19 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
31 Participants
n=41 Participants
|
66 Participants
n=35 Participants
|
35 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
10 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
6 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
6 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
4 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=41 Participants
|
92 Participants
n=35 Participants
|
45 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: Intent to treat; patients were assessed weekly
Number of Remitted Participants (defined as 3 consecutive weeks with HRSD-17≤8 and YMRS≤8)
Outcome measures
| Measure |
IPSRT Plus Quetiapine
n=47 Participants
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)
|
Placebo
n=45 Participants
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)
|
|---|---|---|
|
Remission
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Analyzed data from participants for whom values were available both at baseline and at twenty weeks
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
Outcome measures
| Measure |
IPSRT Plus Quetiapine
n=21 Participants
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)
|
Placebo
n=26 Participants
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)
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)-Short Form
|
10.6 units on a scale
Standard Deviation 10.9
|
4.7 units on a scale
Standard Deviation 11.4
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
IPSRT Plus Quetiapine
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=44 participants at risk；n=45 participants at risk
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)
|
IPSRT Plus Quetiapine
n=44 participants at risk；n=47 participants at risk
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)
|
|---|---|---|
|
General disorders
Early Weight Gain
|
0.00%
0/44 • 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.
|
4.5%
2/44 • Number of events 2 • 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.
|
|
General disorders
Oversedation
|
79.5%
35/44 • Number of events 35 • 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.
|
95.5%
42/44 • Number of events 42 • 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.
|
Additional Information
Holly A. Swartz M.D.
University of Pittsburgh School of Medicine
Phone: 412-246-5588
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place