NCT01133821

Acute Psychotherapy for Bipolar II Depression

Completed Phase 4 Results posted Last updated 7 December 2017

What this trial tests

Phase 4 trial testing IPSRT plus placebo (IPSRT-PLA) in Bipolar Disorder in 92 participants. Completed in 1 October 2015.

Timeline

1 August 2010

Primary endpoint
1 October 2015

1 October 2015

Quick facts

Lead sponsor	Holly Swartz
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	92
Start date	1 August 2010
Primary completion	1 October 2015
Estimated completion	1 October 2015
Sites	1 location across United States

Drugs / interventions tested

• IPSRT plus placebo (IPSRT-PLA) — full drug profile →
• IPSRT plus quetiapine — full drug profile →

Conditions studied

• Bipolar Disorder — all drugs for Bipolar Disorder →
• Depression — all drugs for Depression →

Sponsor

Holly Swartz — full company profile →

Who can join

Adults 18 to 65, any sex, with Bipolar Disorder or Depression. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Remission
  Time frame: 20 weeks
  Number of Remitted Participants (defined as 3 consecutive weeks with HRSD-17≤8 and YMRS≤8)

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychotherapy Alone and Combined With Medication as Treatments for Bipolar II Depression: A Randomized Controlled Trial.
   Swartz HA, Rucci P, Thase ME, Wallace M, et al · · 2018 · cited 28× · PMID 28703949 · DOI 10.4088/jcp.16m11027
2. Effects of Interpersonal and Social Rhythm Therapy on Suicidal Ideation in Adults With Bipolar II Depression.
   Bailey BC, Early TJ, Williams-Sites KE, Dyson B, et al · · 2025 · cited 1× · PMID 41037752 · DOI 10.4088/jcp.24m15768
3. Identifying Anticipated Events of Future Clinical Trials by Leveraging Data from the Placebo Arms of Completed Trials.
   Tan XL, Kern DM, Cepeda MS. · · 2021 · PMID 33165761 · DOI 10.1007/s43441-020-00237-w