Study Summary
This trial will study how to better treat bipolar patients who are suicidal by looking at environmental and psychological factors, as well as implementing a 6-week intervention program.
Eligible Conditions
- Depression
- Substance Abuse
- Alcoholism
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
9 Primary · 1 Secondary · Reporting Duration: Pre-intervention, Post-intervention (Up to six weeks)
Post-intervention (Up to six weeks)
Acquired Capability for Suicide Scale (ACSS) Score
Psychache Scale Score
Pre-intervention, Post-intervention (Up to six weeks)
Change in Altman Self-Rating Mania Scale (ASRM) Score
Change in Beck Scale for Suicide Ideation (BSS) Score
Change in Impulsive/Premeditated Aggression Scale (IPAS) Score
Change in Interpersonal Needs Questionnaire-15 (INQ-15) Score
Change in World Health Organization Quality of Life-Brief (WHOQOL-BREF) Score
Change in the Demographic Data Form Answers
Columbia-Suicide Severity Rating Scale
The Beck Depression Inventory-II (BDI-II)
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Group Intervention Program
1 of 1
Experimental Treatment
130 Total Participants · 1 Treatment Group
Primary Treatment: Psycho-education & Understanding Bipolar Medications Therapy · No Placebo Group · N/A
Group Intervention ProgramExperimental Group · 4 Interventions: Interpersonal and Social Rhythm Therapy (ISRT), Bipolar-Specific Cognitive Behavioral Therapy (CBT), Mindfulness-Based Stress Reduction (MBSR), Psycho-education & Understanding Bipolar Medications Therapy · Intervention Types: Behavioral, Behavioral, Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Stress Reduction (MBSR)
2016
Completed Phase 2
~1260
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-intervention, post-intervention (up to six weeks)
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,558 Previous Clinical Trials
2,765,611 Total Patients Enrolled
57 Trials studying Depression
8,533 Patients Enrolled for Depression
Dorian Lamis, PhDPrincipal Investigator - Emory University
Emory University
Eligibility Criteria
Age 18 - 64 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been diagnosed with Bipolar Disorder.
Who else is applying?
What state do they live in?
| Georgia | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Grady Health System | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Au, Josephine S., Ana Martinez de Andino, Yara Mekawi, Madison W. Silverstein, and Dorian A. Lamis. 2020. “Latent Class Analysis of Bipolar Disorder Symptoms and Suicidal Ideation and Behaviors”. Bipolar Disorders. Wiley. doi:10.1111/bdi.12967.
- Dorian Lamis 2016. "Suicidal Behavior in Patients Diagnosed With Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02604277.