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Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Holly Swartz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00411463
First received: December 12, 2006
Last updated: March 7, 2017
Last verified: March 2017
Results First Received: January 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Bipolar II Disorder
Interventions: Behavioral: Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Drug: Seroquel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Psychotherapy   Medication
STARTED   14   11 
COMPLETED   11   8 
NOT COMPLETED   3   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Psychotherapy   Medication   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   11   25 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 40.1  (11.7)   32.1  (12.8)   36.1  (12.25) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  50.0%      8  72.7%      15  60.0% 
Male      7  50.0%      3  27.3%      10  40.0% 
Region of Enrollment 
[Units: Participants]
     
United States   14   11   25 


  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   Descriptive Measures of the Feasibility of IPSRT-BPII   [ Time Frame: Week 12 ]

4.  Secondary:   Number of Participants With a Response   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: swartzha@upmc.edu


Publications of Results:

Responsible Party: Holly Swartz, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00411463     History of Changes
Other Study ID Numbers: 0608080
Study First Received: December 12, 2006
Results First Received: January 5, 2016
Last Updated: March 7, 2017