Acute Psychotherapy for Bipolar II Depression
Condition: Bipolar Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: IPSRT plus placebo (IPSRT-PLA); IPSRT plus quetiapine
Intervention description: 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)
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar II Disorder; Bipolar II Depression; Psychotherapy; IPSRT; Seroquel; Quetiapine; Placebo; Sugar Pill

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age 18 - 65

          -  Meets criteria for bipolar II disorder, currently in an episode of major depression,
             as defined by the DSM-IV (American Psychiatric Association, 1994) and documented by
             the use of the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I), and
             by a rating of >15 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)

          -  Ability and willingness to give informed, written consent.

          -  Subjects may participate in this study if they are currently taking psychotropic
             medications at time of informed consent. They will remain in the study (and be
             randomized) if they still meet eligibility criteria after a one week wash-out period.

        Exclusion Criteria:

          -  Severe or poorly controlled concurrent medical disorders that may cause confounding
             depressive symptoms (i.e., untreated hypothyroidism or lupus) or require medication(s)
             that could cause depressive symptoms (i.e., high doses of beta blockers or alpha
             interferon)

          -  Meets criteria for one of the following concurrent DSM-IV psychiatric disorders: any
             psychotic or organic mental disorder, bipolar I disorder, current alcohol or drug
             dependence, primary obsessive compulsive disorder or primary eating disorders.
             (primary refers to the diagnosis associated with the most functional impairment);
             borderline personality disorder; antisocial personality disorder

          -  Acute suicidal or homicidal ideation or requiring psychiatric hospitalization.
             Subjects who require inpatient treatment will be excluded (or discontinued) from the
             study and referred to one of WPIC's inpatient mood disorder units, or, if preferred,
             to an inpatient facility nearer to the patient's home

          -  Severe cognitive deficits that would preclude treatment with psychotherapy and/or
             prevent completion of study questionnaires

          -  Non-fluent in English. Subjects must be able to speak and understand English because
             one of the study interventions, IPSRT, is an experimental talk-therapy. This therapy
             cannot practically be translated.

          -  Current participation in another form of individual psychotherapy. Concurrent
             participation in couples therapy, peer support groups (such as Alcoholics Anonymous),
             or family therapy will be permitted

          -  Prior lack of response to a trial of at least 12 weeks of IPSRT conducted by a
             certified therapist

          -  Prior lack of response to at least 6 weeks of 300 mg of quetiapine

          -  Currently pregnant or planning to become pregnant during the trial