Psychotherapy for Bipolar II Depression, Pilot Study, Phase II
|ClinicalTrials.gov Identifier: NCT00411463|
Recruitment Status : Completed
First Posted : December 14, 2006
Results First Posted : April 19, 2017
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar II Disorder||Behavioral: Interpersonal and Social Rhythm Therapy (IPSRT-BPII) Drug: Seroquel||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Psychotherapy for Bipolar II Depression, Pilot Study, Phase II|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Behavioral: 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.
Other Name: IPSRT
Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
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.
Other Name: Quetiapine
- Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10 [ Time Frame: Week 12 ]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.
- Quality of Life (QOL) Collected Using the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) [ Time Frame: Baseline and Week 12 ]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%.
- Descriptive Measures of the Feasibility of IPSRT-BPII [ Time Frame: Week 12 ]Feasibility was assessed by ability to enroll, randomize, and retain participants in this trial. Completion of the study was used as evidence of feasibility.
- Number of Participants With a Response [ Time Frame: Week 12 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411463
|United States, Pennsylvania|
|University of Pittsburgh /University of Pittsburgh Medical Center (UPMC)|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Holly Swartz, M.D.||University of Pittsburgh|