Seroquel in the Treatment of Dysphoric Hypomania in Bipolar II

NCT00186043 | Completed Phase 4 Results

• 1 other identifier: 79739
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate the utility of Seroquel add-on treatment to decrease mixed depressive and hypomanic symptoms.

Conditions

Bipolar II Disorder

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With >=50% Improvement From Baseline in Clinical Global Impression for Bipolar Disorders Overall Severity

  0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days.

  Baseline and 8 weeks

• Percentage of Participants With Clinical Global Impression for Bipolar Disorders Overall Severity Remission (Score <=2 at Week 8)

  0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days.

  Week 8

Secondary Outcomes (1)

• Percentage of Participants With 50% Improvement From Baseline in Both Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) Scores

  Baseline and 8 weeks

Study Arms (2)

Quetiapine/Seroquel

EXPERIMENTAL

Quetiapine/Seroquel up to 800 mg/day

Drug: Quetiapine/Seroquel

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Quetiapine/Seroquel DRUG

Quetiapine/Seroquel

Quetiapine/Seroquel

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Must meet criteria for DSM-IV TR diagnosis of bipolar II disorder, as assessed by the structured clinical interview mood modules (SCID) (First et al., 1996).
• Must be hypomanic as rated by a \>12 on the YMRS on two consecutive visits 1-3 days apart. And meet DSM IV TR criteria for hypomania
• Must be experiencing depressive symptoms as rated by \> 14 on the MADRS rated at two consecutive visits 1-3 days apart and experiencing depressive symptoms for at least a seven-day period.
• Must be on stable medication regimens for at least two weeks, or on no medication at study entry.
• Must be men or women age 18-65 years of age.
• Must be able to give informed consent.
• Must be able to comprehend and satisfactorily comply with protocol requirements.
• If sexually active, females of child-bearing potential must be using a reliable method of contraception, which includes hormonal contraceptives, double-barrier methods (e.g., condom and foam, condom and diaphragm), intrauterine devices (IUD), or tubal ligation. Oral hormonal contraception is allowed as long as no other medications are being used that could decrease hormone levels and put the patient at risk for developing pregnancy.

You may not qualify if:

• Receiving any atypical antipsychotics (washout period to be determined by treating psychiatrist)
• Receiving recognized antidepressant medication (within five half-lives), including serotonin reuptake inhibitors, venlafaxine, bupropion, or nefazodone.
• Receiving carbamazepine (within five half-lives).
• Experienced a hypomanic episode judged to be a direct physiological consequence of any medical condition or treatment, including neurological disorders, cardiovascular disease, metabolic or autoimmune conditions.
• Evidence that the patient is likely to need additional concomitant medical therapy during the trial.
• Participated in another trial of an investigational drug/device \*or received clozapine within 30 days prior to baseline.
• Known hypersensitivity to Seroquel or any of its components.
• Known intolerability or past history of ineffectiveness of Seroquel.
• Met DSM-IV TR criteria for any substance or alcohol abuse or dependence disorder within the past month.
• History or evidence of unstable medical condition or known clinically significant abnormal laboratory results.
• Known or suspected chronic infectious disease including HIV or hepatitis.
• Women who are currently pregnant or desire to become pregnant during the study or women nursing an infant.
• Meet criteria for antisocial personality disorder.

Sponsors & Collaborators

• Stanford University: lead
• AstraZeneca: collaborator

Study Sites (1)

Terence Ketter

Stanford, California, 94305, United States

Location

Related Publications (1)

• Suppes T, Ketter TA, Gwizdowski IS, Dennehy EB, Hill SJ, Fischer EG, Snow DE, Gonzalez R, Sureddi S, Shivakumar G, Cosgrove VE. First controlled treatment trial of bipolar II hypomania with mixed symptoms: quetiapine versus placebo. J Affect Disord. 2013 Aug 15;150(1):37-43. doi: 10.1016/j.jad.2013.02.031. Epub 2013 Mar 19.

  PMID: 23521871 RESULT

Related Links

• Stanford Bipolar Disorders Clinic Website

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Results are limited in their generalizability due to the small sample drawn from two specialty clinics for mood disorders clinical research. Suspected assignment to active quetiapine or placebo possibly influencing ratings on outcome variables

Results Point of Contact

• Title: Trisha Suppes MD, PhD
• Organization: Bipolar and Depression Research Program, Stanford University, School of Medicine, VA Palo Alto Health Care System

tsuppes@stanford.edu

6504962567

Study Officials

• Terence Ketter, MD

  Stanford University

  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, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 27, 2017
• Results First Posted: September 27, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)