Trial Outcomes & Findings for Psychotherapy for Bipolar II Depression, Pilot Study, Phase II (NCT NCT00411463)
NCT ID: NCT00411463
Last Updated: 2017-05-30
Results Overview
Overall response rates (defined as greater than or equal to 50% reduction in depression scores without an increase in mania scores) were 29% (n=4) in the IPSRT group and 27% (n=3) in the quetiapine group. HRSD-25 scores are based on first 17 responses. Eight items are scored on a 5-pt scale, from 0 (not present) to 4 (severe.) Other nine items on the assessment are scored from 0-2. The higher the score on the HRSD-25, the worse the outcome is considered to be. A score of 0-7 is considered to be normal; 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression, and any score greater than or equal to 23 indicates very severe depression. The YMRS is an 11 point assessment. There are 4 items assessed on a scale ranging from 0 to 8 and the other 7 items are graded on a 0 to 4 scale. As with the HRSD, the higher the score on the YMRS indicates the presence of more or more severe manic symptoms and is associated with a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
25 participants
Primary outcome timeframe
Week 12
Results posted on
2017-05-30
Participant Flow
Participant milestones
| Measure |
Psychotherapy
Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms.
|
Medication
Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychotherapy for Bipolar II Depression, Pilot Study, Phase II
Baseline characteristics by cohort
| Measure |
Psychotherapy
n=14 Participants
Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms.
|
Medication
n=11 Participants
Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
36.1 years
STANDARD_DEVIATION 12.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Overall response rates (defined as greater than or equal to 50% reduction in depression scores without an increase in mania scores) were 29% (n=4) in the IPSRT group and 27% (n=3) in the quetiapine group. HRSD-25 scores are based on first 17 responses. Eight items are scored on a 5-pt scale, from 0 (not present) to 4 (severe.) Other nine items on the assessment are scored from 0-2. The higher the score on the HRSD-25, the worse the outcome is considered to be. A score of 0-7 is considered to be normal; 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression, and any score greater than or equal to 23 indicates very severe depression. The YMRS is an 11 point assessment. There are 4 items assessed on a scale ranging from 0 to 8 and the other 7 items are graded on a 0 to 4 scale. As with the HRSD, the higher the score on the YMRS indicates the presence of more or more severe manic symptoms and is associated with a worse outcome.
Outcome measures
| Measure |
Psychotherapy
n=14 Participants
Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms.
|
Medication
n=11 Participants
Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule.
|
Total
Total number of participants
|
|---|---|---|---|
|
Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10
50% reduction in HRSD 25 score and YMRS <= 10
|
4 participants
|
3 participants
|
—
|
|
Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10
Non-responder
|
10 participants
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12The total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.
Outcome measures
| Measure |
Psychotherapy
n=14 Participants
Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms.
|
Medication
n=11 Participants
Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule.
|
Total
Total number of participants
|
|---|---|---|---|
|
Quality of Life (QOL) Collected Using the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)
Baseline
|
34.6 scores on Q-LES-Q scale
Interval 30.0 to 39.3
|
40.0 scores on Q-LES-Q scale
Interval 35.2 to 45.6
|
—
|
|
Quality of Life (QOL) Collected Using the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)
Post-Intervention
|
37.0 scores on Q-LES-Q scale
Interval 32.0 to 41.9
|
48.7 scores on Q-LES-Q scale
Interval 43.2 to 54.3
|
—
|
SECONDARY outcome
Timeframe: Week 12Feasibility was assessed by ability to enroll, randomize, and retain participants in this trial. Completion of the study was used as evidence of feasibility.
Outcome measures
| Measure |
Psychotherapy
n=14 Participants
Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms.
|
Medication
n=11 Participants
Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule.
|
Total
n=25 Participants
Total number of participants
|
|---|---|---|---|
|
Descriptive Measures of the Feasibility of IPSRT-BPII
|
11 Participants
|
8 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Week 12Number of participants with response defined as an average of 50% (or greater) reduction in the subject's baseline HRSD-25 score over three consecutive weeks and a current YMRS score ≤ 10
Outcome measures
| Measure |
Psychotherapy
n=14 Participants
Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms.
|
Medication
n=11 Participants
Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day
Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.
This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.
Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule.
|
Total
Total number of participants
|
|---|---|---|---|
|
Number of Participants With a Response
|
4 Participants
|
3 Participants
|
—
|
Adverse Events
Psychotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place