STOP-D clinical trial

[mollyecho]

Hello,

I was wondering if anyone else is part of this clinical trial?

[pinkvision]

What is STOP-D?

[Leaf100 in reply to pinkvision]

I hope the original poster answers.

In the meantime I got curious and found this - basically they recognize people with BI get depressed and so are chucking people on an sertraline (Zoloft) as a preventative.

Antidepressants are evidently now considered 'best practise' for people with bi.

I have a strong personal bias on this one so I shall now zip my mouth.

Leaf

[Stubble in reply to Leaf100]

I hear you. I was given nortriptyline with instructions to up the dose over a number of weeks in order to manage the headache component. I really didn't react well. They made me very sluggish and disoriented and when I upped the dose I felt even worse.

I weaned off and was relieved to be away from the experience!

[pinkvision in reply to Leaf100]

It's the one that was talked about on the Jeremy Vine show (BBC Radio 2) a while ago and people on here had a discussion about it. Here's a link to the study

hra.nhs.uk/planning-and-imp...

Unlike you Leaf I am happy to talk about my bias, I'm not in favor of general use of antidepressants for everyone who has a brain or head injury.

The key to understanding this study is the definition of depression symptoms:

In this study they are:

Low mood.

Loss of enjoyment in everyday life.

The study design is also flawed because there is not an active alternative.

I'll explain

As far as defining depression there are multiple definitions and all of them are theoretical. There is only one test that can be performed as far as I know and that's measuring the size of the amygdala with an MRI scan. People who have chronic depression have an enlarged left hemisphere amygdala. (People with PTSD have an enlarged right hemisphere amygdala).

The problem with this study is that it does not separate the effects of fatigue after a brain injury from the low mood supposedly caused by depression.

From my own experience I had fatigue but I did not have depression. My understanding of depression is that it is cyclic negative thinking about yourself, and it can be CAUSED by a low mood; it is not the low mood/fatigue itself.

What causes a low mood/ fatigue after brain injury? The acute and sub acute effects of a dysfunctional brain while it is repairing. The biggest effect of this is hormonal imbalance and body regulatory factors such as stress.

In 2023 hypopituitary testing was recommended by NICE as a primary test after a head/ brain injury. Another marker is low vitamin B12 levels.

From my own experience the loss of enjoyment in everyday life was caused by the lack of medical intervention, having to deal with the DWP and having to go through a legal fight. This did not cause depression it caused anxiety. Anxiety differs from depression in that it is caused by worry about the future. In my experience is can be 'treated' instantly by getting what you want, winning your battles with the health system, DWP and legal system.

We all had a chat on here a while back about what causes depression, some people said they were prone to depression before they had a brain injury, so having a brain injury made no difference; someone said they got depressed before a brain injury and after the brain injury they never had depression after. Others said their depression was caused by the sheer sense of hopelessness because there was no realistic medical/ rehab/ care/ DWP/ Legal support after brain injury.

The study suggests 50% of people with brain injury get depression, are those UK figures? because the global figure say 28% (again that would come down to how they defined depression). 28% is only 3% percent higher than the figure that says 25% of all people would get chronic mental health problems (depression, anxiety or PTSD) following a trauma. The global figures tally more or less with those prone to mental health issues. In other words about 25% of people would get depression after a brain injury because they are predisposed to it.

This trial is going to prescribe everyone either an antidepressant or placebo immediately after a head/brain injury.

The long term effects of taking antidepressants are unknown. They have side effects that are worse than the symptoms of brain injury for some, they don't treat the symptoms of brain injury ie memory, cognition etc. And in a huge study in Canada involving thousands of patients they found that long term use of antidepressants in the over 50's causes dementia.

The last major drug trial specifically trying 'cures' for brain injury was in the early 2000's (it was called the CRASH study) which involved routinely giving all TBI patients glucocortosteroids because they had shown promise with halting MS. After TBI patients started to die the trial was halted and many of the remaining patients developed acute chronic symptoms. A later study called the IMPACT study found the problems were caused because all brain injuries are unique and the defining all TBI's as the same injury can't be done. In other words each brain injury has to be treated for the symptoms each person has. If you are not prone to depression then taking antidepressants routinely may do more harm than good.

The study trial is flawed because they are not using a viable alternative as a control. They are only using placebos. Modern research trials are considered flawed if they don't use a viable alternative.

My suggestion for a viable alternative would be to have a cohort/ group of patients going through a well structured treatment regime that had state of the art diagnostics, rehab, after care, easy DWP support (that even paid the morgage), quick legal resolution etc. My thinking is that if they actually treated people and gave them all the support they needed including real rehab then most people would not get depressed in the first place. Then for those that do get depressed antidepressants may be an alternative at a later stage.

To me this study is horrifying. I'm wondering how long the public enquiry will take after it all goes tits up.

[Leaf100 in reply to pinkvision]

Thanks PV, you put that a lot better than I could and I do know some people find the devil works. (For me anti depressants are a devil.)

I agree completely it is not a one size fits all and I am an example where I was tricked into taking an antidepressant - I knew they did not work for me because I had tried one for its off label use as a sleep aide prior to bi.

What was bad before bi was a nightmare after - it caused hallucinations....oh, just when I had my eyes closed. So, when I was trying to sleep...everytime I blinked. One day I may use that as the basis for a novel. It would be more à la Stephen King than Hallmark. If I hadn't had the sense to quit in the face of the system's demand I take it, I really don't know what would have happened.

Like you what I needed was basic support - an income and a doc who was willing to treat my other symptoms- not chuck a mood alerting substance at me and ignore the rest.

When people have income issues and can't work and are in massive pain or having symptoms they cant inderstand, of course they will be stressed - and should be stressed. Anyone would be stressed. It's normal. Stress makes everything worse. What we need at that time is help that actually addresses the issues we face on an individual basis.

(I will mention here that some.drugs that are routinely rx'd for bi actually mess with your DNA, and haven't been tested properly. On principle alone no one should be forced to take them or to not be properly informed before taking them.)

Anyway this study would be outlawed if it were up to me and putting bi people on an antidepressant as a 'best practise' - it just makes me angry. They should know better.

They need to study how many people who arent injured have issues with them causing harm.

I used to work with a place that had a lot of employees and I knew a few people who went on antidepressants and then went off because they said they felt worse - that having some ups and downs was better than feeling nothing all the time.

I suspect antidepressants are a massively misused medication in general.

Likely this is a topic that triggers some ptsd for me- we can get it twice potentially - once from.the injury causing incident and again because of the sh***y way we get treated after- even to the point of the system being quite comfortable with causing us harm. And it is.

And this also flies in the face of the whole idea of state centered learning.

I would never, ever, let someone I loved participate in such a study. If it were in my power I would pull the plug on it. It's absolutely dangerous for some people

Leaf

[mollyecho in reply to Leaf100]

Thank you both for your detailed responses.

Apologies if the topic is in any way triggering. My only intent was to see if there was anyone here also on the trial, as opposed to discussing the trial itself. It was my partner’s choice to take part; I wouldn’t make such a decision for him.

[Leaf100 in reply to mollyecho]

No worries on my end, millyecho. It may turn out to be right for him, and if it's not going well he has you to advocate to get him out of it - if it comes to that.

You also may be aware of things he isn't.

Awareness is something we all struggle with because our processing is impacted.

He's very lucky to have you in his corner.

Leaf

[Teazymaid]

no have you ? I just checked it out and I know some people don’t like anti depressants and others do .. truthfully I’m pleased they are doing research and it I lived near I would be interested just a shame for me there is no neuro in Cornwall , so it’s basically zero rehab down here . I do take antidepressants and took them pre TBI .. I’ve tried stopping them and my depression got worse .. but the dead , emotionally removed bit stay the same so I am back on them .. not with depression ( as suicidal) but still have the emotional dead, removed from this world , anger,anxiety etc .. i just happy they are doing research as without a doubt we need help Sue x

[mollyecho]

kcl.ac.uk/research/stop-d-s...

My partner was “recruited” following his TBI in August 2023 and is just finishing up the tablets. At the latest appointment with the research team (who have been great), they mentioned a lot of the people they’ve got to take part in the study have a very similar story to my partner - male, 30s, cycling accident. So I wondered whether there was anyone on here.

[pinkvision in reply to mollyecho]

Just wondering did your partner get the antidepressant or the placebo? were you told after the trial?

[mollyecho in reply to pinkvision]

The trial is still ongoing and we won’t find out until two years after the last participant completes it. So a while!

[Mhelpsme]

I’ve been on antidepressants since the beginning. My TBI caused deep depression and aggressive mood swings. I was not a nice person to be around. A totally different person after the accident.

I live in North Devon and, like Tearymaid, there are very few facilities or experts here for people who have had a TBI. No neuro therapists at all. I tried to wean off them once and couldn’t control the mood swings.

It’s a personal preference for me, I’d put all my energy into my family and working to give them a good start in life, I now just wish to slow down and relax. Taking the antidepressants mean I don’t have to fight every day with depression, anger, anxiety, or fear. I just have to concentrate on managing my short term memory and the physical aspects (spatial awareness, shaking etc).

I think it’s good they are doing research. Maybe they’ll create something that can control the emotional side without the use of ADs.

Mhelpsme