Invega Experiments on Keith Torkelson MS

 Invega Experiments on Keith Torkelson MS

Feature Image [MIKEL R]

Symptomatic

Abstract – Executive Summary
Purpose of this study

The primary purpose of this study is to help others and us determine that Invega Sustenna (IS) is not indicated.  Our presenting problems are complicated with IS.  Our primary problems are Anxiety and a Sleep Disorder.  Now we have adverse reactions to IS to deal with.  For the life of us until we read up on IS we could not figure what was causing our symptoms. 

Results up Front - Adverse Reactions and Side Effects 
Most bothersome effects associated with Invega

 

Side Effects - Real World Evidence

In order to get a thorough understanding of what Invega Sustenna (IS) may be doing to us we apply the Evidenced Based Practice of self-assessment.  Some say self-assessment yields Real World Evidence (RWE).  We created a few assessment tools for this study.

Action Plan

Our plan is to summarize this material in a manner that it is easy to present to our psychiatrist Dr. Bera.  Unlike Dr. Bum Soo Lee who took us off (circa 2012) cold-turkey from IS doctor Bera has started to titrate us down.  Our next appointment is in August of 2024.

When is INVEGA Not Indicated?

”Basically INVEGA or related are not a good choice when the primary major tranquilizer is needed in a rhythmic nature – for sleep (when somnolence is desired) – to treat anxiety - and extrapyramidal side effects are not acceptable.”

Cost and Benefit

We had been stable on Clozapine since 2012.  The cost of Invega Sustenna (IS) is exorbitant in terms of money.  As far as cost is concerned IS should be at least 25 times better for us than Clozapine.  IS is also costly for us as far and adverse reactions are concerned.  It is very likely that IS is impeding our recovery.  This document includes part of our Mental Illness History (MIH).

 

Introduction – Back Story

Assessing Invega Efficacy – Compare with actual data

Efficacy for Schizoaffective Disorder Treatment Medication - INVEGA

Significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores9

INVEGA® (3 mg, 6 mg, 9 mg, 12 mg) demonstrated significant improvements in PANSS total scores vs placebo as monotherapy (P<0.001) and as adjunctive therapy in two 6-week pivotal studies (P=0.014)*†

PANSS Scores for INVEGA®

Numerical improvement in Young Mania Rating Score (YMRS) In pivotal trials, numerical improvement in YMRS total score was larger with INVEGA® compared to placebo*†  INVEGA® is not indicated for the treatment of manic episodes in bipolar I disorder

YMRS Scores for INVEGA®

Numerical improvement in Hamilton Depression Rating Scale (HAM-D-21)9 In pivotal trials, numerical improvement in HAM-D-21 total score was larger with INVEGA® compared to placebo*†  INVEGA® is not indicated for treatment of depressive episodes in Major Depressive Disorder

HAM-D-21 Scores for INVEGA®

[STAYED]

Assessments in Context of Invega

YMRS Young Mania Rating Score   
PANSS Positive and Negative Syndrome Scale   
BARS Barnes Akathisia Rating Scale

Introduction

Assessing Invega Risks

Paliperidone - Wikipedia, the free encyclopedia

https://en.wikipedia.org/wiki/Paliperidone

Paliperidone - Wikipedia

“Paliperidone, sold under the brand name Invega among others, is an atypical antipsychotic.  It is mainly used to treat schizophrenia and schizoaffective disorder. It is marketed by Janssen Pharmaceuticals.  Paliperidone like its parent compound functions as an inverse agonist at 5-HT2A. Paliperidone is also active by acting as an antagonist of the alpha 1 and alpha 2 adrenergic receptors as well as the H1 histaminergic receptors. ”

When Invega is not indicated

Basically Invega or relared are not a good choice when the primary major tranquilizer is needed inn a rhythmic nature for sleep (when somnolence is desired) to treat anxiety – and extrapyramidal side effects are not acceptable.

Side Effects - Very Common (>10% incidence)

Headache

Somnolence (causes less sedation than most atypical antipsychotics)

Insomnia

Hyperprolactinaemia (Only if it interferes with intimacy)

Side Effects - Common (1-10% incidence)

Extrapyramidal side effects (EPSE)

“(EPSE; e.g. dystonia, akathisia, muscle rigidity, Parkinsonism. It appears to produce similar EPSE to risperidone, asenapine and ziprasidone and more EPSE than olanzapine, clozapine, aripiprazole, quetiapine, amisulpride and sertindole.”

Weight gain

Weight gain (tends to produce a moderate degree of weight gain, possibly related to its potent blockade of the 5-HT2C receptor)

Associated Document

10_Profile_17102903_List_of_Psychiatrists

Introduction - History Taking Table

The following is a table that lists most of our psychiatrists, their working diagnoses, and how well they took a history.  Doctor Dobos at Kaiser did the best with history taking.  Our current treatment is built off of the progress each doctor made with us.  The table is organized alphabetical rather than chronological.

 Doctor Cipher

Last Reviewed: 20240729-M: UD = Undocumented

Introduction – History Taking

How is it that a searching history matters?

Since our first episode in 1989 we have been given multiple diagnoses.  A good history such as Dr. Dobos offered would demonstrate that we currently suffer Anxiety with a Sleep Disorder.  If our coping is exhausted a crisis ensues that can lead to suffering psychosis.  If the doctor can’t see our diagnosis clearly we often are served inappropriately.  This is why we assess ourselves. Yet few doctors really ask for the results of our assessments.

Introduction - Legal - 2024 LPS Conservatorship

It occurred to us that we could be on LPS Conservatorship.  None of the places we stayed during 2024 started a temporary conservatorship with us.  This includes: Aliso Ridge, Global & Leisure.  The Powers that Be must feel we are in good enough shape to advocate for ourselves.  This includes exercising our “Right to Refuse” one or more treatments.  The last thing we want to do is refuse Invega.  It would tarnish our association with Dr. Bera.

LPS (Mental Health) Conservatorship | County of Santa Clara

Superior Court of California | County of Santa Clara (.gov)

“A mental health (LPS) conservatorship makes one adult (called the conservator) responsible for a mentally ill adult (called the conservatee). These conservatorships are only for adults with mental illnesses listed in the Diagnostic and Statistical Manual of Mental Disorders (DSM).”

Introduction - Super Lawyers – Right to Refuse 

Undesirable Treatment – Right to Refuse

“Competent adults have the constitutional right to privacy, which by court rulings has been interpreted to include the right to refuse medical treatments. Adults also have the protections of tort law, in that any unwanted medical procedure is considered an unwanted touch, or even assault or battery.” Jan 26, 2023

Introduction - Invega Trial – Revisited

Back in 2012 once again we were having trouble getting sleep.  Our roommate Karl was going berserk 24/7.  We had relapsed to drinking beer.  Our program Brand New Day had placed us in the Lighthouse Residential Treatment Program (RTP).  Things were looking up until the staff psychiatrist, Dr. Daniels, decided we needed something different than Clozapine.  She persuaded us and put us on Invega. It was an utter disaster and landed us in the hospital.  In the hospital we linked with Dr. Bum Soo Lee (BSL).  Our partnership with BSL would last more than the next five years.  When he first began treating us we reconsidered Invega.  He decided to discontinue Invega and resume with Clozapine.

Introduction - Legacy Papers

The following is a ListerLista about our work focusing on Clozapine.  We find that Clozapine is a rigorous medication to manage.  Even though it is challenging on a monthly basis Clozapine has been good to us ever since doctor Singh started us on it back in 2007.  Our rate of hospitalization has gone down to two episodes in twelve years while on Clozapine (2012 & 2024).  Below are things we got to consider with respect to being a long-term Clozapine patient.  In 2024 being off Clozapine had no benefits only costs.

Clozapine…

15_Clozapine_Publications_Work_Done_21072704_Notes

28 Day Cycle
Alternatives
CBC Registry
Charter
Clozapine Algorithm
Cost Containment
Determination
Gap Error
Gap Intervention
Inspiration
Med Management
Rate Gilbert
Ref – Clozapine Determination
Side Effects
Situation for Family
Work Done

Introduction - Risks - Risperdal and Invega Overview | Recall Report

Dangerous Drugs and Products

Risperdal and Invega are prescription antipsychotic medications that have been linked to increased risks of developing serious medical issues.

What are the evidences of mental health problems?

“Significant tiredness, low energy or problems sleeping. Detachment from reality (delusions), paranoia or hallucinations. Inability to cope with daily problems or stress. Trouble understanding and relating to situations and to people.” Dec 13, 2022

Results - 3.0 - Experimental Bunny Rabbit – Invega

Medication List & Outcomes - Most if not all

Reference Document

10_BMB_Psychotropics_16121602_Experiments V2024

Results – The Table

Since our first treatment back in 1989 we have been on some odd twenty-eight (28) medications.  More than six (6) of these have been anti-psychotics.  The anti-psychotic that worked and works best is Clozapine.  Seroquel and Serzone worked fairly well also.  The two that worked the worst were Haldol and Navane.  Risperidone like Invega have little or no beneficial effect. Organized Alphabetical Rather Chronological.

Table – Master Medications List – Part I of II

E# = Experiment Number (Alphabetical)
Pass = Effective
RYNT = Requested yet Not Tried
TE = Too Expensive

Results - Assessments

For this paper and in preparation for our next appointment in August 2024 we employ about ten (10) assessments.  The most important ones focus on Invega and Clozapine.  We wrote several assessments ourself.

Results - How is it we are Vulnerable?
Hospital Readmission And Social Risk Factors
What is a factor that increases the risk for re-hospitalization?

“When the authors adjusted for demographic and clinical factors, four of the seven selected social factors were significantly associated with increased readmission risk.”

Characteristics of 30-Day All-Cause Hospital Readmissions

What is the rate of re-hospitalization for 30 days?

“Source: Agency for Healthcare Research and Quality (AHRQ), Healthcare Cost and Utilization Project (HCUP), Nationwide Readmissions Database (NRD), 2016-2020. The 30-day all-cause readmission rate for all hospital stays remained stable at 13.9 per 100 index admissions from 2016 to 2020.” Sep 22, 2023

Results - Adherence

“In medicine, patient compliance describes the degree to which a patient correctly follows medical advice. Most commonly, it refers to medication or drug compliance, but it can also apply to other situations such as medical device use, self-care, self-directed exercises, or therapy sessions.”

 

Results

Real World Evidence - Assessment

Assessment is an Evidenced Based Practice.  It is high up there with Best Practices. The following assessments we found associated with what Invega Sustenna purports to do.  The assessments deliver Real World Evidence (RWE).

Results – Assessments – Invega Associated

Results - Evidence

Comparative Assessments

Associated Document
Leisure_Crisis_Cigs_Meds_Sleep_2024060701_Notes
Results - Table – Post Leisure Problems
We noticed these before we were informed about Invega’s Side Effects
Table – Post Leisure Problems
Higher scores are problematic

Last Reviewed: 20240717-W:

Published 20240726-F

We first published this table on 20240726-F

 Results - Comparing Invega Sustenna with Clozapine

Below we compare Invega Sustenna to Clozapine.  We address problematic side effects.  The majority of them we took from the Janssen site.

The most common side effects of INVEGA SUSTENNA® include:

Table – Invega Sustenna side effects - Compare with Clozapine
R = Reverse Score
Low Scores are Favorable

FYI - Side Effects & Safety | Janssen Portfolio of LAIs - Invega

https://www.janssenschizophreniainjections.com/side-effects-and-safety/

GoodRx

FYI – Invega - Results - Benefits of Invega Sustenna

“It's used to improve mood, thoughts, and behaviors in adults who have schizophrenia or schizoaffective disorder. Invega Sustenna (paliperidone) is a long-acting injection that's given into the muscle, typically once a month, by a trained healthcare provider.”

Clozapine - StatPearls - NCBI Bookshelf

National Institutes of Health (NIH) (.gov)

Benefits of Clozapine Nov 10, 2023

“Lower risk of suicide (clozapine has been shown to reduce suicidal behavior even in patients with non-treatment-resistant schizophrenia and schizoaffective disorder).”

Aspect

Note (Clozapine) - Lowers risk of suicide, Plus

Just as a panic attack is automatic so can be an impulse to die.  Clozapine lowers the risk of developing tardive dyskinesia.  In our case it reversed TD.  Clozapine improves cognition and Quality of Life (QOL).  Our QOL is gradually improving.  Clozapine decreases the chance of relapse.  We have been out of the hospital for just over 5 weeks. 

Results - Invega Adverse Reaction Driven Comparative Assessment

Low scores are favorable

Result – Sample of Costs

20240729-M: Cost Calculations This is an estimate for the cost of Invega Sustenna.  Per injection around $1,500 divided by 30 days equals $50 per day.  Thus, Invega should be at least 25 percent better than Clozapine and resolve all of my mental problems with no side-effects.  This is not the case.

Research

High Weight Items – Akathisia & tardive dyskinesia (TD)

“Commonly Observed Adverse Reactions for INVEGA SUSTENNA®: The most common adverse reactions in clinical trials in patients with schizophrenia (≥5% and twice placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder.”

WebMD

Invega Sustenna gone wrong

“Get medical help right away if you have any very serious side effects, including: fainting, severe dizziness, slow heartbeat, seizures. Paliperidone may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent.”

Feature Doctors

BSL & Bera Ten years on Clozapine  
Daniels 1st use of Invega Injection  
Vu Never considered Invega  
Lee Put us back on Clozapine  
Kline (Control) Favors Clozapine  

Discussion

Cost (Loss) Management - Lived Experience Outline

2012 Light House – The Daniel’s Experiment

In 2012 we were drinking beer.  We started after we completed fall semester at Cypress College in 2011.  As Matt put it “you are drinking too much”.  Eventually we ended up in a residential treatment program called the Lighthouse.  The doctor, Dr. Daniels, said that she had something that would “put us in a place better than ever”.  She took away Clozapine and replaced it with Invega Injections.  We were so sick we could no longer determine what works and what doesn’t.  For three days she gave us a barbiturate which masked our sleep problem.  We have found we are totally reliant on Clozapine. 

Dr. Daniels > Bun Soo Lee MD

After the first three days she took away the Barbiturate and we remained awake for 72 Hours.  Eventually the program sent us to the hospital to be evaluated.  Dr. Bum Soo Lee (BSL) evaluated us and then admitted us to the psych ward at Western Med Anaheim.  He gave us Restoril to sleep.  It was helpful yet not as efficacious as Clozapine.  When release we linked with BSL and he agreed Clozapine would fit better than Invega.  On Clozapine we were out of the hospital from 2013 till 2024.

Leisure was Hospitalization - Invega

In 2024 we have been hospitalized as of July 28th three (3) times.  The first one at Aliso Ridge should have worked but housing and poor social support interfered.  In March of 2024 we were sent to Global for impropriety.  We were released from Global to Leisure to wait for a Housing Waver.  In all we spent seventy-five (75) days at Leisure.  For us this stay was counter-therapeutic.  We have been out of “the hospital” just over thirty (30) days.  For us we need to be out till the end of this year for the episode to be closed.  Once again, we are dealing with Anxiety complicated by a Sleep Disorder.  Our new Dr. Bera driven treatment plan took effect July 1st, 2024.  We have been sleeping well.  Yet strong evidence indicates that Invega is working against us.

2024 March Presenting Problems

As we mentioned earlier our Rent a Shared Roommate (RASR) had problems with mania, bullying, gambling and anger.  He also suffered Sleep Apnea and he destroyed property.  After coping with him for more than two (2) years we finally got worn out.  We became psychotic, having many mistaken beliefs, and demonstrated impropriety.  The landlady called 911 for our impropriety. 

Clozapine Hell

We were admitted to Global’s psych ward. We had reservations about Clozapine so they took us off and replaced it with Invega Sustenna.  The next 72 hours are what we call Clozapine Hell.  We didn’t sleep for 72 hours.  Our cold-turkeying off Clozapine was for us near absolute suffering and misery.  The link below is to a paper describing how we managed Clozapine at Leisure Circle our next lay over.  Even with three medications: Ativan, Restoril and Invega Sustenna they do not substitute for Clozapine.

FYI - Medication Gaps

https://clozapinerx4ecstasy.blogspot.com/2024/07/medication-gaps-returning-to-normalcy.html

MR Vignette

We’ve watched many people on Invega and Invega Sustenna.  We only take notice if we share a room with them or they die.  While sharing a room with Mikel R. he was placed on Risperidone then Invega.  Neither really helped.  Mikel was restless all day and all night.  This gradually made it very hard for us to get sleep.  We talk about sleep a good deal.  That is because we consider sleep for us the most important daily factor for health and preventing relapse.

FYI - Spell Risperidone

Minded Medication

We call being vigilant about our medicines Minded Medication.  Appointments and pharmacy are things we think about and plan for daily.  This report is a product of Minded Medication. 

Discussion - Structured Temporal Reconciliation (STR)

One of our coping tools we call Structured Temporal Reconciliation (STR).  STR is like charting.  In 2024 we charted for: the episode, Leisure, Sleep, our over-niters, and gals we were interested in.  We have lost the ability to leverage our STR method.  Charting and writing are a couple of methods for coping with our Anxiety.

What direction is stable?

“Signs that someone is mentally and emotionally stable: A sense of being in control of their personal thoughts and actions. A sense of (general) well-being. Friends and family are generally confident in the individual's ability to care for themselves physically, emotionally, and spiritually.”

What direction is recovery?

By definition, the recovery process must be self-directed by the individual, who defines his or her own life goals and designs a unique path towards those goals.

Bera Vignette – Mindful Medication V Long Lasting

20150609-TU – Conflict - Centered About Meeting of the Minds (MOMs)

At MOMs Dr. Bera stated in his presentation that his organization (JHF) was using “state of the art” approaches.  At MOMs Dr. Bera MD along with another JHF helper gave a presentation on their operation. At most he mentioned three psychotropics.  He concentrated about 3 minutes on the INVEGA series.  Knowing from Dr. Chau that the pharmaceutical companies pay MD’s to promote pharmaceuticals, we saw Bera MDs presentation as a sales pitch for the INVEGA series. 

Invega Sales and Marketing

We started this report back in 2017 in response to having a problematic roommate (MR).  MR was placed on Invega and it did little or nothing to help him.  The manufacturer needs to make a twenty item or so assessment to measure Invega’s efficacy.  Maybe we are benefiting and don’t know.  Back in 2017 we saw that Invega was being promoted in our clinics waiting room.  We saw this focus on one medication as a Conflict of Interest.

Find Photo Documentation

Lived Experience – Cohort (Stable yet not Recovering or Thriving)

Character Invega Injection Result Note

• Led (TF) Ineffective Manic – Angry – Bully - Gambler 
• Easp (MO) Lower functionality - By 2024 he was doing nothing for himself 
• James Younger (JY) Ineffective Manic 
• Mark (RKM) Caused problems - Committed suicide 
• Mikel (MR) Ineffective Eventually got on something that worked a bit 
• 2012 Self (KET) Ineffective - Resulted in hospitalization 

Treatment Preferences

You might wonder how is it Clozapine?  We were diagnosed in 1989.  It took until 2006 or seventeen years to get put on Clozapine.  There is something called the Clozapine Algorithm.  Based on it we were a candidate for Clozapine years before 2006.  Out of dozens of meds we know Clozapine is the best fit.  SleepAble factors (environment and agents) are a few of the things that Clozapine cannot conquer.  Our Rent a Shared Room roommate Ted gave up no Peace for more than two years.  He broke us.

Anxiety

Intense, excessive, and persistent worry and fear about everyday situations. Fast heart rate, rapid breathing, sweating, and feeling tired may occur.  Common Causes. Anxiety can be normal in stressful situations such as public speaking or taking a test. Anxiety is only an indicator of underlying disease when feelings become excessive, all-consuming, and interfere with daily living.

Anxiety in Psychiatry

…a mental condition characterized by excessive apprehensiveness about real or perceived threats, typically leading to avoidance behaviors and often to physical symptoms such as increased heart rate and muscle tension.  Example "we are seeing more calls related to anxiety and depression"

DSM 5 Anxiety Disorder

How does the DSM-5 describe anxiety?

The anxiety and worry are associated with three or more of the following six symptoms with at least some symptoms present for more days than not for the past 6 months: restlessness or feeling keyed up or on edge, easily fatigued, difficulty concentrating or mind going blank. Jun 1, 2022

Orthostatic hypotension

A primary reason we wanted to get off Clozapine

“Symptoms of orthostatic hypotension include lightheadedness, weakness, blurred vision, and syncope or passing out.  When a person stands up from sitting or lying down, the body must work to adjust to that change in position. The body needs to push blood upward and supply the brain with oxygen. If the body fails to do this adequately, blood pressure falls, and a person may feel lightheaded or even pass out.”

Weakness

“Orthostatic hypotension is the term used to describe the fall in blood pressure when a person stands (orthostatic= upright posture of the body; hypo= less + tension=pressure). Orthostatic Hypotension (Low Blood Pressure When Standing) ... Symptoms of orthostatic hypotension include lightheadedness, weakness, blurred vision, and syncope or passing out. ...” 

XenoNet

XenoNet refers to our system and network to keep our medicine coming without any gaps.

Xenobiotic

“Adjective = Relating to or denoting a substance, typically a synthetic chemical, that is foreign to the body or to an ecological system.  Noun = Substances that are foreign to the body or to an ecological system.”

Associated Concepts - 1.3 - Medication Error(s)

From 2013–2023 we suffered few medication errors.  The main errors were phlebotomy errors where the blood drawer had problems poking the vessel. In 2024 we suffered many errors with medication continuity.  At Leisure Circle, we were made to go sleepless about 7 gaps between Lorazepam and Restoril.  As of today, July 28, 2024, we were chalking up our symptoms to brain damage incurred at Leisure were the 7 gaps occurred.  Staying up sleepless cooked our brain.  In other words we suffered some brain damage over the course of 75 days.

FYI - Our papers on this Episode

Auto_T-Rex_Case_14090202_Leisure V2024

https://ktork46.blogspot.com/2024/05/crisis-and-episode-2023-2025-for-and-by.html

Leisure_Crisis_Cigs_Meds_Sleep_2024060701_Notes

https://clozapinerx4ecstasy.blogspot.com/2024/07/medication-gaps-returning-to-normalcy.html

Diagnoses

Since 1989 we have had some six (6) diagnoses made by professionals: Bi-polar is used the most.  No one has on paper diagnosed our Anxiety.  We feel that we suffer and have suffered Anxiety complicated by Sleep Disorder for most of our adult life.  The Sleep Disorder is obvious, we cannot sleep without medication.  Clozapine is so far the best medication to help us Sleep.  In addition it helps with symptoms that Invega Sustenna (IS) is supposed to help with.

Coping failure

In 2023 we were overwhelmed by our home environment and an agent our roommate.  We had successfully coped for more than two years.  Our roommate was suffering: Mania, anger issues, gambling problems and was a measureable passive aggressive bully.  As December 2023 came around our Sleep was impaired more than ever.  We became psychotic and demonstrated impropriety.  We were hospitalized for impropriety not suicidality or homicidality.  We had become gravely disabled.  We were trying to find something if need be to replace Clozapine so we agreed to IS.

Invega History - Dr. Daniels > Bun Soo Lee MD (Revised)

In 2012 we were treated by Dr. Daniels at the Lighthouse residential treatment facility in Anaheim.  She cold-turkeyed us off Clozapine and initiated Invega injections.  She augmented with a Barbiturate.  After the first three days she took away the Barbiturate and we remained awake for 72 Hours.  Eventually the program sent us to the hospital to be evaluated.  Dr. Bum Soo Lee (BSL) evaluated us and then admitted us to the psych ward at Western Med Anaheim.  He gave us Restoril to sleep.  It was helpful yet not as efficacious as Clozapine.  When released we linked with BSL and he agreed Clozapine would fit better than Invega.  We were out of the hospital from 2013 till 2024.