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Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

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ClinicalTrials.gov Identifier: NCT00411463
Recruitment Status : Completed
First Posted : December 14, 2006
Results First Posted : April 19, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Holly Swartz, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar II Disorder
Interventions Behavioral: Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Drug: Seroquel
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Psychotherapy Medication
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 14 11
Completed 11 8
Not Completed 3 3
Arm/Group Title Psychotherapy Medication Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 14 11 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 11 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
11
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 11 participants 25 participants
40.1  (11.7) 32.1  (12.8) 36.1  (12.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 11 participants 25 participants
Female
7
  50.0%
8
  72.7%
15
  60.0%
Male
7
  50.0%
3
  27.3%
10
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 11 participants 25 participants
14 11 25
1.Primary Outcome
Title Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10
Hide Description 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.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psychotherapy Medication
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 14 11
Measure Type: Number
Unit of Measure: participants
50% reduction in HRSD 25 score and YMRS <= 10 4 3
Non-responder 10 8
2.Secondary Outcome
Title Quality of Life (QOL) Collected Using the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)
Hide Description The 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%.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psychotherapy Medication
Hide Arm/Group Description:
Patients assigned to talk therapy (IPSRT) intervention during 12 weeks of active enrollment in study.
Patients taking Quetiapine (Seroquel) during 12 weeks of active treatment.
Overall Number of Participants Analyzed 14 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: scores on Q-LES-Q scale
Baseline
34.6
(30.0 to 39.3)
40.0
(35.2 to 45.6)
Post-Intervention
37.0
(32.0 to 41.9)
48.7
(43.2 to 54.3)
3.Secondary Outcome
Title Descriptive Measures of the Feasibility of IPSRT-BPII
Hide Description Feasibility was assessed by ability to enroll, randomize, and retain participants in this trial. Completion of the study was used as evidence of feasibility.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psychotherapy Medication Total
Hide Arm/Group Description:

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.

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 number of participants
Overall Number of Participants Analyzed 14 11 25
Measure Type: Count of Participants
Unit of Measure: Participants
11
  78.6%
8
  72.7%
19
  76.0%
4.Secondary Outcome
Title Number of Participants With a Response
Hide Description Number 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
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psychotherapy Medication
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 14 11
Measure Type: Count of Participants
Unit of Measure: Participants
4
  28.6%
3
  27.3%
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Psychotherapy Medication
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Psychotherapy Medication
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Psychotherapy Medication
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Psychotherapy Medication
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Holly Swartz, MD
Organization: University of Pittsburgh
Phone: 412-246-5588
Responsible Party: Holly Swartz, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00411463     History of Changes
Other Study ID Numbers: 0608080
First Submitted: December 12, 2006
First Posted: December 14, 2006
Results First Submitted: January 5, 2016
Results First Posted: April 19, 2017
Last Update Posted: May 30, 2017