Acute Psychotherapy for Bipolar II Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Bipolar Disorder, Depression

In brief

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.

Key facts

Study ID

NCT01133821

Run by

Holly Swartz

People needed

92

Starts

2010-08-01

Expected to finish

2015-10-01

Last updated by the study team

2018-01-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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