Quetiapine for Post-Concussion Syndrome
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Foundation for Advancing Veterans' Health Research
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD).
Is the drug Quetiapine Fumarate a promising treatment for Post-Concussion Syndrome?Quetiapine Fumarate shows potential as a treatment for Post-Concussion Syndrome because it has been effective in protecting the brain after traumatic injuries and in treating mood disorders. It has also been used successfully in patients with schizophrenia and bipolar disorder, suggesting it could help with brain-related issues.135610
What safety data exists for Quetiapine treatment?The safety data for Quetiapine, also known as Seroquel or Quetiapine Fumarate, primarily comes from studies on its use in schizophrenia. These studies indicate that Quetiapine has demonstrated efficacy and tolerability in patients with schizophrenia, including high- and low-dose comparisons with placebo, and comparisons with other antipsychotics like risperidone. Additionally, it has been evaluated for its pharmacokinetics, tolerability, and clinical effectiveness in adolescents with psychotic disorders. Animal model studies have also assessed its potential to induce extrapyramidal side effects.13468
What data supports the idea that Quetiapine for Post-Concussion Syndrome is an effective drug?The available research does not provide direct evidence supporting the effectiveness of Quetiapine for Post-Concussion Syndrome. However, a pilot study mentioned in the research shows that Quetiapine was effective in reducing irritability and aggression in patients with traumatic brain injury, which is somewhat related to post-concussion symptoms. This study found that Quetiapine helped improve cognitive functioning in these patients. There is no direct comparison to other treatments for Post-Concussion Syndrome in the provided information.12579
Do I have to stop taking my current medications for the trial?The trial does not specify if you must stop taking your current medications, but you must be stable on at least three CNS active psychotropic medications for over a month. You cannot currently be taking any antipsychotics or prohibited medications.
Eligibility Criteria
This trial is for veterans aged 18-65 with mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD), who have been stable on at least three CNS psychotropic medications for over a month. Participants must have PTSD symptoms and report post-concussion syndrome (PCS) symptoms, with the mTBI occurring at least six months prior to screening.Inclusion Criteria
I am a veteran aged 18-65 seeking treatment for a mild traumatic brain injury.
I have had a mild traumatic brain injury and still experience symptoms after six months.
Treatment Details
The study compares quetiapine monotherapy—a medication that can affect neurotransmitters in the brain—to standard treatment as usual (TAU). It's designed to see if quetiapine is more effective in managing symptoms of mTBI and PTSD in veterans undergoing rehabilitation therapy.
2Treatment groups
Experimental Treatment
Active Control
Group I: QuetiapineExperimental Treatment1 Intervention
Quetiapine will be cross-tapered up to a maximum dose of 200 mg (as tolerated) as other standard of care medications are discontinued.
Group II: Treatment As Usual (TAU)Active Control1 Intervention
Participants in the TAU group will have doses adjusted over the same period as indicated by usual care criteria.
Quetiapine Fumarate is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Seroquel for:
- Schizophrenia
- Bipolar disorder
- Major depressive disorder
🇪🇺 Approved in European Union as Seroquel for:
- Schizophrenia
- Bipolar disorder
- Major depressive disorder
🇨🇦 Approved in Canada as Seroquel for:
- Schizophrenia
- Bipolar disorder
- Major depressive disorder
Find a clinic near you
Research locations nearbySelect from list below to view details:
New Mexico VA Healthcare SystemAlbuquerque, NM
South Texas Veterans Healthcare SystemSan Antonio, TX
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Who is running the clinical trial?
Foundation for Advancing Veterans' Health ResearchLead Sponsor
The University of Texas Health Science Center at San AntonioCollaborator
Biomedical Research Institute of New MexicoCollaborator
References
Quetiapine in patients with schizophrenia. A high- and low-dose double-blind comparison with placebo. Seroquel Study Group. [2022]Quetiapine fumarate (Seroquel [ICI 204,636]) is an atypical dibenzothiazepine antipsychotic with a greater affinity for 5-hydroxytryptamine2 (5-HT2) receptors than for D2 dopamine receptors; its efficacy in patients with schizophrenia was shown in early phase 2 trials (maximum dose, 750 mg/d).
Open-label quetiapine in the treatment of children and adolescents with autistic disorder. [2015]The purpose of this trial was to investigate the short-term safety and efficacy of quetiapine fumarate in the treatment of children and adolescents with autistic disorder (AD).
Pharmacokinetics, tolerability, and clinical effectiveness of quetiapine fumarate: an open-label trial in adolescents with psychotic disorders. [2019]This is the first investigation of the pharmacokinetics, tolerability, and efficacy of quetiapine fumarate in adolescents with chronic or intermittent psychotic disorders.
Atypical antipsychotic effects of quetiapine fumarate in animal models. [2013]To evaluate the effect of quetiapine fumarate in animal models of schizophrenia and its possibility to induce extrapyramidal side effects (EPSE).
Quetiapine alone and added to a mood stabilizer for serious mood disorders. [2019]Use of antipsychotic medication intermittently or over the long term may be necessary in treating patients with bipolar disorder whose symptoms have responded suboptimally to standard mood-stabilizing agents. Quetiapine fumarate is an effective novel antipsychotic with mixed serotonergic (5-HT2) and dopaminergic (D2) activity. This is an open-label, 12-week prospective study to assess the efficacy and tolerability of quetiapine in the treatment of patients with bipolar and schizoaffective disorder who were suboptimally responsive to mood stabilizers alone.
Dosing and switching strategies for quetiapine fumarate. [2022]The atypical antipsychotic agent quetiapine fumarate has demonstrated efficacy and tolerability in clinical trials in patients with chronic or subchronic exacerbations of schizophrenic symptoms.
A pilot study of quetiapine treatment of aggression due to traumatic brain injury. [2019]In a 6-week open-label, flexible dose pilot study of quetiapine for treatment of aggression secondary to traumatic brain injury (TBI), seven subjects who were at least 3-months post-injury were enrolled. The Overt Aggression Scale - Modified (OAS-M) and Clinical Global Impression (CGI) were primary outcome measures. Administration of quetiapine at doses of 25 to 300 mg daily was efficacious and well-tolerated in reducing irritability and aggression resulting from TBI, with an associated improvement in cognitive functioning.
Comparison of quetiapine and risperidone in Chinese Han patients with schizophrenia: results of a single-blind, randomized study. [2022]To evaluate the efficacy and safety of 750 mg/day quetiapine fumarate (Seroquel) in the treatment of Chinese Han patients with schizophrenia.
Long-term efficacy and safety of quetiapine in treatment-refractory schizophrenia: A case report. [2014]The recent advent of atypical antipsychotics has provided new clinical options and set higher expectations for the treatment of schizophrenia. Such agents might more effectively prevent relapse because they are more effective against the full spectrum of schizophrenic symptoms, as well as having improved tolerability and leading to improved medication compliance. Quetiapine fumarate ('Seroquel') is a new dibenzothiazepine antipsychotic agent with a greater affinity for serotonin receptors than for dopamine receptors and with a lower propensity for producing extrapyramidal symptoms or increasing prolactin levels. It has recently been approved for the treatment of psychotic disorders; however, the long-term efficacy and safety of quetiapine for treating treatment-refractory schizophrenia is still being investigated. We present a case of a 58-year-old man suffering from chronic therapy-resistant schizophrenia, with both positive and negative symptoms, who was successfully treated with quetiapine for 5 years. To the best of our knowledge, this is the first report of such long beneficial use of quetiapine in a hospital clinical practice. (Int J Psych Clin Pract 2000; 4:77-80).
Role of quetiapine in protection of neurodegeneration after traumatic brain injury. [2020]Schizophrenia is a chronic psychotic disorder in which patients experience positive and negative symptoms for over six months. Schizophrenia is associated with early mortality, with 40% of this excess mortality due to suicide. This is a case of patient with schizophrenia who was treated with quetiapine after suffering a traumatic brain injury and recovered enough to be discharged to a rehabilitation unit. This case illustrates the neuroprotective effects of quetiapine in treating neurologic deficits in a patient who recently suffered a traumatic brain injury.