NCT00183703

Brief Summary

This study will examine how various factors, such as psychiatric symptoms, gender, quality of life, and attitudes toward medication, affect treatment adherence in individuals with rapid cycling bipolar disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2004

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

2.3 years

First QC Date

September 14, 2005

Last Update Submit

February 4, 2019

Conditions

Bipolar Disorder

Keywords

Depression, BipolarManic-Depressive Psychosis

Outcome Measures

Primary Outcomes (1)

  • The Subjective Experience of Medication Interview (SEMI)

    The Subjective Experience of Medication Interview (SEMI) is a qualitative, semi-structured assessment of subjective experience of mental illness, which requires approximately 60-120 minutes to administer. Illness experience domains assessed include illness attitudes, attributions and behaviors, social relations, treatment history and medication experience, self-medication, quality of life, stigma, culture/ethnicity, and health care logistics. The SEMI has been modified for use in populations with Bipolar Disorder.

    Baseline

Secondary Outcomes (7)

  • Hamilton Depression Rating Scale (HAMD)

    Baseline

  • Clinical Global Impression (CGI)

    Baseline

  • Insight and Treatment Attitudes Questionnaire (ITAQ)

    Baseline

  • Illness Behavior Questionnaire (IBQ)

    Baseline

  • Attitude Towards Mood Stabilizers Questionnaire (AMSQ)

    Baseline

  • +2 more secondary outcomes

Study Arms (1)

Qualitative Interview

Participants with rapid cycling bipolar disorder (RCBPD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population includes 20 individuals receiving treatment at an academic medical center and 20 individuals seeking treatment at a community mental health clinic.

You may qualify if:

  • Clinical diagnosis of rapid cycling variant of bipolar disorder type I; diagnosed 2 to 20 years prior to study entry
  • Has experienced an index depressive episode
  • Received treatment with medication to stabilize mood for at least 6 months prior to study entry
  • Lives in the Northeast Ohio area and is a patient at either Northeast Ohio Health Services or The Mood Disorders Clinic at University Hospitals of Cleveland

You may not qualify if:

  • Unable/unwilling to participate in psychiatric interviews

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northeast Ohio Health Services

Beachwood, Ohio, 44122, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

  • Sajatovic M, Jenkins JH, Cassidy KA, Muzina DJ. Medication treatment perceptions, concerns and expectations among depressed individuals with Type I Bipolar Disorder. J Affect Disord. 2009 Jun;115(3):360-6. doi: 10.1016/j.jad.2008.10.002. Epub 2008 Nov 8.

    PMID: 18996600RESULT

  • Sajatovic M, Jenkins JH, Safavi R, West JA, Cassidy KA, Meyer WJ, Calabrese JR. Personal and societal construction of illness among individuals with rapid-cycling bipolar disorder: a life-trajectory perspective. Am J Geriatr Psychiatry. 2008 Sep;16(9):718-26. doi: 10.1097/JGP.0b013e3180488346. Epub 2007 Dec 10.

    PMID: 18070834RESULT

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Martha Sajatovic, MD

    Case Western Reserve University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and of Neurology

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

July 1, 2004

Primary Completion

November 1, 2006

Study Completion

August 1, 2007

Last Updated

February 6, 2019

Record last verified: 2019-02

Locations

US(2)