Psychotherapy for Bipolar II Depression, Pilot Study, Phase II
Condition: Bipolar II Disorder
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Purpose of this study is to examine the effectiveness of an experimental psychotherapy (talk
      therapy) for the treatment of bipolar II depression. The name of this psychotherapy is
      Interpersonal and Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). Subjects will
      be randomly assigned to receive either IPSRT-BPII or the medication Seroquel (quetiapine) to
      manage their symptoms of bipolar II depression. Subjects will receive the assigned therapy
      for up to 20 weeks.
    

Detailed description: 
      The proposed pilot study is an experimental design intended to investigate the preliminary
      efficacy of Interpersonal Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). A
      total of 56 eligible subjects with a diagnosis of bipolar II disorder will be randomly
      assigned to one of two treatment groups : Seroquel (n=28) or IPSRT-BPII (n=28). Following
      baseline assessment, all participants will undergo up to 20 weeks of their assigned
      treatment. Patients assigned to IPSRT-BPII who fail to respond (at least 50% reduction in
      HRSD-25 scores and YMRS ≤ 10) by week 12 will have Seroquel added to IPSRT-BPII. Subjects who
      achieve remission (defined as 3 consecutive weeks where both HRSD-25 and YMRS scores average
      ≤ 7) and have participated in the trial for a minimum of 12 weeks will be moved into a
      continuation phase where they will receive maintenance treatment (bi-monthly therapy sessions
      and/or pharmacotherapy) until week 20. Patients who do not achieve remission by Week 20 will
      be discontinued from treatment and referred for follow-up care. All subjects (remitters and
      non-remitters) will be assessed at 20 weeks.
    

Intervention name(s): Interpersonal and Social Rhythm Therapy (IPSRT-BPII); Seroquel
Intervention type(s): Behavioral; Drug
Intervention description(s): 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 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 intervention name(s): IPSRT; Quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interpersonal Therapy; Social Rhythm Therapy; Bipolar Disorder; Depression; Seroquel