Acute Psychotherapy for Bipolar II Depression

Holly Swartz

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder; Depression

Treatments: Drug: IPSRT plus placebo (IPSRT-PLA); Drug: IPSRT plus quetiapine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01133821

MH084831 (Other Grant/Funding Number)

PRO08090019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus placebo (sugar pill). This condition will be called IPSRT-PLA.

Treatment:

Drug: IPSRT plus placebo (IPSRT-PLA)

IPSRT plus quetiapine

Experimental group

Description:

Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel). This condition will be called IPSRT-QUE.

Treatment:

Drug: IPSRT plus quetiapine