Depression Clinical Trial
Official title:
Treatment of Bipolar Type II Major Depression
This study will compare the safety and effectiveness of antidepressant therapy versus mood stabilizing therapy in treating people with bipolar type II major depression.
Bipolar type II (BP II) depression affects 2.5% of the U.S. adult population. People with BP
II disorder do not experience the manic episodes that are characteristic of BP I disorder,
but rather they experience more modest mood swings with a greater number of major depressive
episodes (MDEs). These MDEs are associated with high rates of disease and death. The
treatment of BP II depression remains a challenge for clinicians. Mood stabilizer (MS)
monotherapy is the current recommended treatment for BD II MDE, but there is reason to
believe that antidepressant drug (AD) monotherapy could also be an effective treatment.
However, concerns over AD-induced manic switch episodes have limited the use of this
treatment option. Preliminary studies using the ADs fluoxetine or venlafaxine have shown
success in treating and lowering the manic switch rate of those with BP II MDE. This study
will compare the safety and effectiveness of AD monotherapy versus MS monotherapy in
treating people with BP II major depression.
Participation in this double-blind study will last up to 9 months. After screening, which
includes a medical and psychiatric history review, a physical exam, an electrocardiogram
(EKG) test, clinical laboratory tests, a urine-based drug test, and a pregnancy test if
applicable, participants will be randomly placed into one of two treatment groups.
Participants in the AD monotherapy group will be treated with venlafaxine, and participants
in the MS monotherapy group will be treated with lithium. During the first 12 weeks, there
will be a total of nine study visits lasting between 45 and 60 minutes. In these visits,
participants will receive their study drug and will undergo various assessments, including a
review of medication history and side effects, vital sign measurements, and questionnaires
about depression and daily functioning. Blood samples will be taken at most visits.
Participants who respond well during the initial 12 weeks of therapy with either drug will
have the option to continue treatment for 6 additional months. During this time,
participants will continue their assigned treatment and will attend five monthly study
visits that will repeat previous assessments and procedures.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00044616
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |