CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 55 enrolled
Drug / intervention
Quetiapine/Seroquel +1 moredrug
Likely dose
Quetiapine dose not specified in protocol; typical dosing range for bipolar disorder is 150-800 mg daily in divided dosesAI-extracted
Key inclusion· 6
  • ✓Confirmed diagnosis of bipolar II disorder by structured clinical interview (SCID)
  • ✓Hypomanic symptoms with YMRS score >12 on two consecutive visits 1-3 days apart, meeting DSM-IV TR hypomania criteria
  • ✓Concurrent depressive symptoms with MADRS score >14 on two consecutive visits 1-3 days apart, lasting ≥7 days
  • ✓Age 18-65 years
Key exclusion· 12
  • ✕Currently receiving atypical antipsychotics
  • ✕Recent antidepressant use within 5 half-lives (SSRIs, venlafaxine, bupropion, nefazodone)
  • ✕Recent carbamazepine use within 5 half-lives
  • ✕Hypomanic episode secondary to medical condition, neurological disorder, cardiovascular disease, or metabolic/autoimmune condition

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

Search/NCT00186043
NCT00186043Phase 4Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled Trial of Seroquel for the Treatment of Dysphoric Hypomania in Bipolar II Patients

Stanford University·interventional·Posted Sep 16, 2005·Updated Sep 27, 2017

In Brief

A Phase 4 clinical trial evaluating Quetiapine/Seroquel and Placebo for Bipolar II Disorder. Completed, enrolled 55 participants across 1 site.

Detailed Summary

1. The primary objective of this study is to examine the efficacy of quetiapine (Seroquel) in treatment of dysphoric hypomania in patients with Bipolar II disorder. 2. To evaluate the utility of Seroquel add-on treatment to decrease mixed depressive and hypomanic symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar II Disorder
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartAug 1, 2008
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.8 years ago

Interventions

Quetiapine/Seroqueldrug

Quetiapine/Seroquel

Placebodrug

Placebo