Acute Psychotherapy for Bipolar II Depression
Condition: Bipolar Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This proposed study is designed to compare the efficacy of interpersonal and social rhythm
      therapy (IPSRT) alone to IPSRT plus medication as an acute treatment for bipolar II
      depression. The investigators propose to conduct a randomized, controlled, trial comparing
      the effects of IPSRT plus pill placebo to IPSRT plus quetiapine on depressive symptoms in
      individuals suffering from Bipolar II depression. The investigators will also examine the
      impact of treatment on psychosocial function.
    

Detailed description: 
      Specifically, we will enroll 160 individuals meeting DSM-IV criteria for BP II disorder,
      currently depressed, and randomly assign them to 20 weeks of treatment with IPSRT plus
      placebo (IPSRT-PLA) (N=80) or IPSRT plus quetiapine (IPSRT-QUE) (N=80). We will evaluate
      potential moderators of response to treatment including circadian phase preference,
      intercurrent hypomanic symptoms during the index depressive episode, clinical and demographic
      factors (i.e, number of previous episodes, family history of mood disorders), and prior
      treatment response to antidepressant medications.
    

Intervention name(s): IPSRT plus placebo (IPSRT-PLA); IPSRT plus quetiapine
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
Medication Dosing
The research pharmacy will dispense medication in the following unit-dose packs:
Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA); Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
Medication Dosing
The research pharmacy will dispense medication in the following unit-dose packs:
Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)
Other intervention name(s): IPSRT-PLA; IPSRT-QUE
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bipolar II Disorder; Bipolar II Depression; Psychotherapy; IPSRT; Seroquel; Quetiapine; Placebo; Sugar Pill