BridgeMD
New treatment option for Bipolar Disorder (BD)
Official title Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations
ClinicalTrials.gov ID: NCT07404085
What this study is testing
- What it's testing
- The aim of this clinical trial is to investigate the effects of a three-week virtual reality-based cognitive remediation training (VR-CRT) programme in combination with daily intake of a histone deacetylase inhibitor (HDACi) sodium butyrate on cognition in symptomatically stable patients with mood disorders (depression or bipolar disorder). The investigators hypothesize that the VR-based cognitive remediation training (VR-CRT) combined with HDACi butyrate vs.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- Confirmed ICD-10 diagnosis of BD or recurrent UD in partial, or full remission (Hamilton Depression Rating Scale-17 items and Young Mania Rating...
- Subjective cognitive complaints (self-reported: COBRA ≥12) or objectively-verified cognitive impairment (measured using Screening for Cognitive...
- Fluency in Danish language
You likely can't join if
- Diagnosis of schizophrenia
- Neurological disorders (including dementia)
- Dyslexia
- Severe Physical illness
- Kidney disease
- Cardiovascular disease
See the full eligibility criteria
- Confirmed ICD-10 diagnosis of BD or recurrent UD in partial, or full remission (Hamilton Depression Rating Scale-17 items and Young Mania Rating Scale scores ≤14)
- Subjective cognitive complaints (self-reported: COBRA ≥12) or objectively-verified cognitive impairment (measured using Screening for Cognitive Impairment in Psychiatry SCIP: total score or at least two subscores ≥ 0.5...
- Fluency in Danish language
- Diagnosis of schizophrenia
- Neurological disorders (including dementia)
- Dyslexia
- Severe Physical illness
- Kidney disease
- Cardiovascular disease
- Diabetes
- Alcohol or substance abuse
- Previous severe head trauma
- History of epilepsy
- Pregnancy or breastfeeding
- BMI \>30
- Bodyweight \< 45kg
- Daily use of benzodiazepines \> 22.5 mg. oxazepam or \> 7.5 mg. diazepam per day
- Serum lithium levels \> 0.8 mmol/L
- Received electroconvulsive therapy \< 2 months prior to participation
- Hypertension (\>140 systolic or \> 90 diastolic mm Hg)
The study team makes the final eligibility decision.
Where it's taking place
- Frederiksberg, Capital Region of Denmark, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frederiksberg, Capital Region of Denmark, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.