View Clinical Trial (Medical Research Study)
Acute Psychotherapy for Bipolar II Depression
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Bipolar Disorder - Depression |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01133821 |
| Primary Contact: |
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Principal Investigator
Holly Swartz, MD
University of Pittsburgh
Joan Buttenfield, RN
Phone: (412) 246-5588
Email: buttenfieldja@upmc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
Joan Buttenfield, RN
Phone: 412-246-5588
Email: buttenfieldja@upmc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
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