Acute Psychotherapy for Bipolar II Depression

NCT01133821 | Completed Phase 4 Results DMC

• 2 other identifiers: PRO08090019MH084831
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Depression

Keywords

Bipolar II Disorder; Bipolar II Depression; Psychotherapy; IPSRT; Seroquel; Quetiapine; Placebo; Sugar Pill

Outcome Measures

Primary Outcomes (1)

• Remission

  Number of Remitted Participants (defined as 3 consecutive weeks with HRSD-17≤8 and YMRS≤8)

  20 weeks

Secondary Outcomes (1)

• Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)-Short Form

  20 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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)

IPSRT plus quetiapine

EXPERIMENTAL

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

Interventions

IPSRT plus placebo (IPSRT-PLA) DRUG

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)

Also known as: IPSRT-PLA

Placebo

IPSRT plus quetiapine DRUG

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)

Also known as: IPSRT-QUE

IPSRT plus quetiapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Holly Swartz: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

WPIC/ Bellefield Towers/Depression and Manic Depression Prevention Program

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Bailey BC, Early TJ, Williams-Sites KE, Dyson B, Swartz HA. Effects of Interpersonal and Social Rhythm Therapy on Suicidal Ideation in Adults With Bipolar II Depression. J Clin Psychiatry. 2025 Sep 29;86(4):24m15768. doi: 10.4088/JCP.24m15768.

  PMID: 41037752 DERIVED

• 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.

  PMID: 28703949 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Limitations include absence of an inactive psychotherapy comparator, high dropouts, and poor remission rates. Power limitations could potentially leading to Type II errors.Our sample was predominantly white which may limit generalizability.

Results Point of Contact

• Title: Holly A. Swartz M.D.
• Organization: University of Pittsburgh School of Medicine

swartzha@upmc.edu

412-246-5588

Study Officials

• Holly Swartz, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 31, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 9, 2018
• Results First Posted: August 15, 2017

Record last verified: 2017-12

Locations

US (1)