Clinical trial NCT01133821: Acute Psychotherapy for Bipolar II Depression
Official title: Acute Psychotherapy for Bipolar II Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Depression
Keywords: Bipolar II Disorder
Bipolar II Depression
Psychotherapy
IPSRT
Seroquel
Quetiapine
Placebo
Sugar Pill
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-05-31
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Remission
timeFrame: 20 weeks
Secondary outcomes:
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)-Short Form
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Holly Swartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swartz HA, Rucci P, Thase ME, Wallace M, Carretta E, Celedonia KL, Frank E. Psychotherapy Alone and Combined With Medication as Treatments for Bipolar II Depression: A Randomized Controlled Trial. J Clin Psychiatry. 2018 Mar/Apr;79(2):16m11027. doi: 10.4088/JCP.16m11027.