PRISM II: An open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury

If you have PBA then IF your doctor is any good at all s/he will be following this study closely and update your stroke protocols upon completion. But I can guarantee that unless YOU tell them about this nothing will happen. Your recovery is solely up to you, you can't depend on your doctors or therapists.
http://www.mdlinx.com/internal-medicine/medical-news-article/2016/06/10/dextromethorphan-quinidine-pseudobulbar-affect-dementia-brain/6712770/?news_id=881&newsdt=061116&subspec_id=488&utm_source=WeeklyNL&utm_medium=newsletter&utm_content=Weeks-Best-Article&utm_campaign=article-section&category=latest-weekly

In this open–label study, the physicians aim to assess the effectiveness of dextromethorphan/quinidine (DM/Q) for pseudobulbar affect (PBA) in patients with dementia, stroke or traumatic brain injury (TBI). This research found that DM/Q was an effective and well–tolerated treatment for PBA secondary to dementia, stroke, or TBI.

Methods

• A total of 367 patients participated with PBA secondary to dementia, stroke, or TBI.
• Participants received DM/Q 20/10 mg twice daily in this open-label, multicenter, 90-day trial.
• The primary outcome was the Center for Neurologic Study-Lability Scale (CNS-LS), assessing change in PBA episode frequency and severity.
• The authors compared the CNS-LS final visit score to baseline (primary analysis) and to the response in a previously conducted placebo-controlled trial with DM/Q in patients with ALS or MS.
• Secondary outcomes included change in PBA episode count and Clinical Global Impression of Change with respect to PBA as rated by a clinician (CGI-C) and by the patient or caregiver (PGI-C).

Results

• Mean (standard deviation [SD]) CNS-LS score improved significantly from 20.4 (4.4) at baseline to 12.8 (5.0) at Day 90/Final Visit (change, -7.7 [6.1]; P < .001, 95 % CI: -8.4, -7.0).
• This magnitude of improvement was consistent with DM/Q improvement in the earlier phase-3, placebo-controlled trial (mean [95 % CI] change from baseline, -8.2 [-9.4, -7.0]) and numerically exceeds the improvement seen with placebo in that study (-5.7 [-6.8, -4.7]).
• Reduction in PBA episode count was 72.3 % at Day 90/Final Visit compared with baseline (P < .001).
• Scores on CGI-C and PGI-C showed that 76.6 and 72.4 % of participants, respectively, were “much” or ”very much” improved with respect to PBA.
• IN this study the most frequently occurring adverse events (AEs) were diarrhea (5.4 %), headache (4.1 %), urinary tract infection (2.7 %), and dizziness (2.5 %); 9.8 % had AEs that led to discontinuation.
• Serious AEs were reported in 6.3 %; however, none were considered treatment related.

Go to PubMed Go to Abstract Print Article Summary Cat 2 CME

Dextromethorphan, Quinidine Effective for Pseudobulbar Affect Secondary to Dementia

This is PBA after dementia, what about after stroke? Whom is going to answer that question? ASA or NSA are you going to sponsor research to answer that f*ckingly simple question? Or are you going to continue to sit on your ass WAITING FOR SOMEONE ELSE TO SOLVE THE PROBLEM?
Dextromethorphan, Quinidine Effective for Pseudobulbar Affect Secondary to Dementia
 A fixed combination of dextromethorphan and quinidine has demonstrated efficacy in treating pseudobulbar affect (PBA) and depressive symptoms in patients with dementia, researchers reported here at the 168th Annual Meeting of the American Psychiatric Association (APA).
“The PRISM-2 is an open label study that enrolled patients with PBA secondary to dementia, stroke, or traumatic brain injury,” explained Andrew Cutler, MD, Florida Clinical Research Center, LLC, Sarasota, Florida.
The analysis focused on patients form PRISM-2 who had PBA secondary to dementia to determine if the medication had any impact on treating any depression that patients experienced.
“The way that this medication works suggests that it will affect mood,” said Dr. Cutler. “These were no patients who had significant clinical depression, but they had depressive symptoms.”
PBA symptoms were significantly enhanced from study entry to the 12-week mark, with a 67.7% decrease in PBA episodes and a mean change of -7.2 on the Center for Neurologic Study-Liability Scale (P< .001).
“By day 90, the PBA episodes were cut down to 3 a week,” said Dr. Cutler, noting patients had multiple PBA episodes daily at study entry. “There was tremendous improvement in episodes of PBA.”
The study also looked at depressive symptoms as measured by the Patient Health Questionnaire-9. They found an improvement on that scale that was statistically significant, with a change from 13.2 at study entry to 7.4 after 12 weeks (P< .001).
Of note, there was not a direct relationship between improvement in PBA symptoms and reduction in depressive symptoms.
The most common adverse events were headache, urinary tract infection, and diarrhoea.
The study was limited by the fact that it was not randomised; rather it was an open-label design.
Funding for this study was provided by Avanir Pharmaceuticals, Inc.
[Presentation title: Dextromethorphan Quinidine for Pseudobulbar Affect Secondary to Alzheimer’s Disease/Dementia: Effect on Mood Symptoms in PRISM-II Dementia Cohort. Abstract P8-085]

Dextromethorphan/Quinidine: A Review of Its Use in Adults with Pseudobulbar Affect

So maybe there is something for emotional lability Ask your doctor about this.

Dextromethorphan/Quinidine: A Review of Its Use in Adults with Pseudobulbar Affect

Yang LP¹, Deeks ED.

Author information

Abstract

Fixed-dose dextromethorphan/quinidine capsules (Nuedexta^®) utilize quinidine to inhibit the metabolism of dextromethorphan, enabling high plasma dextromethorphan concentrations to be reached without using a larger dose of the drug. The drug combination is the first treatment to be approved for pseudobulbar affect (PBA), a condition of contextually inappropriate/exaggerated emotional expression that often occurs in adults with neurological damage conditions, such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, traumatic brain injury, Alzheimer's disease or Parkinson's disease. Dextromethorphan/quinidine at the recommended dosages of 20/10 or 30/10 mg twice daily reduced the rate of PBA episodes and improved PBA severity in a 12-week, double-blind, placebo-controlled trial in adults with ALS or MS (STAR), with further improvements in the severity of the condition observed in a 12-week open-label extension phase. Dextromethorphan/quinidine 20/10 mg twice daily also improved PBA secondary to dementia in a cohort of a 12-week noncomparative trial (PRISM II). The drug combination was generally well tolerated in these studies, with no particular safety or tolerability concerns. Although longer-term efficacy and tolerability data for dextromethorphan/quinidine 20/10 or 30/10 mg twice daily would be beneficial, current evidence indicates that it is a useful option in the treatment of adults with PBA.