Acute Psychotherapy for Bipolar II Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01133821
First received: May 27, 2010
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Depression
Drug: IPSRT plus placebo (IPSRT-PLA)
Drug: IPSRT plus quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Acute Psychotherapy for Bipolar II Depression

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Depression severity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

    The primary endpoint is depression severity at week 20, which will be measured via the Hamilton Rating Scale for Depression 17-item score (HRSD-17) and the Young Mania Rating Scale (YMRS).

    Remission is defined as 3 consecutive weeks with HRSD-17≤8 and YMRS≤8



Secondary Outcome Measures:
  • Psychosocial functioning [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    We hypothesize that subjects assigned to IPSR-QUE will experience greater improvements in psychosocial functioning over time compared to those assigned to IPSRT-PLA. The main outcomes will be the changes in Q-LES-Q, IIP, and LIFE-RIFT over 52 weeks


Estimated Enrollment: 160
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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.
Drug: IPSRT plus placebo (IPSRT-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)

Other Name: IPSRT-PLA
Experimental: Quetiapine
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.
Drug: IPSRT plus quetiapine

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)

Other Name: IPSRT-QUE

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133821

Contacts
Contact: Joan Buttenfield, RN (412) 246-5588 buttenfieldja@upmc.edu

Locations
United States, Pennsylvania
WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Joan Buttenfield, RN    412-246-5588    buttenfieldja@upmc.edu   
Principal Investigator: Holly Swartz, MD         
Sub-Investigator: Ellen Frank, PhD         
Sub-Investigator: Isabella Soreca, MD         
Sub-Investigator: Roger Haskett, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Holly Swartz, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01133821     History of Changes
Other Study ID Numbers: PRO08090019, MH084831
Study First Received: May 27, 2010
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Bipolar II Disorder
Bipolar II Depression
Psychotherapy
IPSRT
Seroquel
Quetiapine
Placebo
Sugar Pill

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014