Bipolar Disorder Clinical Trial
— MONARCAOfficial title:
Electronic Daily Self-monitoring of Subjective and Objective Symptoms in Bipolar Disorder - The MONARCA Project (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes)
Bipolar disorder is associated with a high risk of relapse and hospitalisation and many
patients do not recover to previous psychosocial function. Major reasons for poor outcome
are delayed intervention for prodromal depressive and manic episodes as well as decreased
adherence with treatment. Recently, electronic self monitoring of affective symptoms using
cell phones to prompt patients to respond to weekly text messages has been suggested as an
easy and cheap way to identify early signs of affective episodes. Nevertheless, so far the
electronic devises has been rather simple not including a bi-directional feed back loop
between patients and providers and without electronic data on "objective" measures of the
affective psychopathology. As part of an ongoing EU research program a software program for
online electronic self-monitoring using a cell phone is being developed including an
interactive feed back loop between patients, relatives and clinicians. Electronic
self-monitoring includes subjective items such as mood, irritability, sleep duration,
activity, alcohol consumption, medication intake and objective items of speech duration (on
the cell phone), social activity (numbers of calls and SMS'es at the cell phone) and
physical activity (acceleration of the cell phone). The present PhD. study will in a
randomized controlled single blind trial including 60 patients with bipolar disorder
allocated to using the active cell phone program (intervention group) or to using a cell
phone to usual communication (control group) during a 6 months study period.
If the cell phone self-monitoring system is proved effective in preventing mood symptoms and
improving psychosocial functioning,quality of life etc. in the present study there might be
basis for extending the use of the system to treatment of patients with bipolar disorder in
clinical practice in general.
Status | Completed |
Enrollment | 78 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of Bipolar disorder - Hamilton Depression Scale under or equal to 17 - Young Mania Rating Scale under or equal to 17 Exclusion Criteria: - Significant somatic disease - Other severe mental illness (schizophrenia, schizoaffective disorder) - Lack of technical skills - Lack of knowledge of Danish - Pregnancy - Lack of desire/willingness to use the delivered cell phone as primary phone |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Psychiatric Center Copenhagen, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Psychiatric Centre Rigshospitalet | IT University of Copenhagen, The European Union, 7.th Frame program, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in Hamilton Depression Rating Scale (HAM-D17) score and Young Mania Rating Scale (YMRS) score during the entire 6 months study period. | The differences in scores on HAM-D17 and YMRS in the areas under the curves between the intervention and the control group. | Measured on all participants included one time a month for six months | No |
Secondary | Psychosocial Functioning (Functioning Assessment Short Test, FAST) | Differences between the two groups in: psychosocial functioning, quality of life, perceived stress, coping strategies,adherence to medication, cognitive function, awakening salivary cortisol, urinary oxidative stress, plasma BDNF, physical activity, self-rated depressive and manic symptoms (secondary) | Measured every month for 6 months on all participants | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT02855762 -
Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder
|
N/A | |
Recruiting |
NCT05915013 -
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
|
Phase 1 | |
Recruiting |
NCT05206747 -
Ottawa Sunglasses at Night for Mania Study
|
N/A | |
Completed |
NCT02513654 -
Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
|
Phase 1 | |
Recruiting |
NCT06313918 -
Exercise Therapy in Mental Disorders-study
|
N/A | |
Completed |
NCT02304432 -
Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine
|
Early Phase 1 | |
Recruiting |
NCT06197048 -
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
|
N/A | |
Completed |
NCT03497663 -
VIA Family - Family Based Early Intervention Versus Treatment as Usual
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT02212041 -
Electronic Cigarettes in Smokers With Mental Illness
|
N/A | |
Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
Active, not recruiting |
NCT03641300 -
Efficacy of Convulsive Therapies for Bipolar Depression
|
N/A | |
Not yet recruiting |
NCT04432116 -
Time and Virtual Reality in Schizophrenia and Bipolar Disorder
|
N/A | |
Completed |
NCT02970721 -
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
|
||
Terminated |
NCT02909504 -
Gao NARASD Lithium Study
|
Phase 4 | |
Terminated |
NCT02893371 -
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
|
||
Recruiting |
NCT02481245 -
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
|
Phase 2 | |
Recruiting |
NCT03088657 -
Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
|