CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 92 enrolled
Drug / intervention
IPSRT plus placebo (IPSRT-PLA) +1 moredrug
Likely dose
IPSRT plus placebo (IPSRT-PLA) 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01133821
NCT01133821Phase 4Completed
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Acute Psychotherapy for Bipolar II Depression

Holly Swartz·interventional·Posted May 31, 2010·Updated Jan 9, 2018

In Brief

A Phase 4 clinical trial evaluating IPSRT plus placebo (IPSRT-PLA) and IPSRT plus quetiapine for Bipolar Disorder and Depression. Completed, enrolled 92 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Depression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 31, 2010
Enrollment StartAug 1, 2010
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 16.1 years ago

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)

IPSRT plus quetiapinedrug

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)