Depression facts

Depression is a common mental disorder. Globally, more than 264 million people of all ages suffer from depression.
Depression is a leading cause of disability worldwide and is a major contributor to the overall global burden of disease.
More women are affected by depression than men.
Depression can lead to suicide.
There are effective psychological and pharmacological treatments for moderate and severe depression.

WHO January 2020

Depression prevalence and treatment success

Point prevalence in Europe 6-8%
Lifetime prevalence more than 20% Hinzpeter, Sass, Ziese (2019)
Sales of antidepressants in Europe are more than 3.7 billions per year
More than 6% of the population in Europe regularly take antidepressants. OECD (2015)
About 60% of all depressed patients do not react properly to initial antidepressant treatments Dold, Kasper (2017)
30% of depression is related to treatment-resistant depressive disorders that do not react properly to the usual treatment with antidepressants (no or inadequate response to at least two different types of antidepressants in a sufficiently high dosage over a sufficiently long time span).
„We found that all antidepressants which were included in the meta-analysis, were more efficacious than the placebo in adults with mayor depressive disorders and the summary effect sizes were predominantly modest“ Cipriani (2018) in The Lancet
Treatment resistant depression was not taken into the account.

3 of 4 people suffering from major depression do not receive adequate treatment – WHO (2017)

Depression treatment with psychotherapy – facts

Psychotherapy ist effective in the treatment of depression
The availability is limited and usually only one hour per week or less
In German S-3 guidelines psychotherapeutic treatment is always recommended for light to moderate depression
“As far as the intensity and concentration of therapeutic influencesare concerned, psychotherapy may need to be reevaluated…The possibility exists, that many of today’s therapeutic efforts to change persistent problematic behaviors, are unsuccessful because of these influences. While, in theory they are correct, they are not intense or vigorous enough.“ Grawe (2004)
The “weekly therapy hour”—in many cases, absent of any quality assessment ensuring reliance of evidence-based approaches—remains the practical default“. Schleider (2020)

Depression treatment with brain stimulation – facts:

A strong, pulsating magnetic field stimulates certain parts of the brain
Repetitive transcranial magnetic stimulation (rTMS) is an evidence based treatment of mayor depressive disorder
Level A evidence (definite efficacy) was reached for … HF-rTMS of the left dorsolateral prefrontal cortex (DLPFC) using a figure-of-8 or a H1-coil for depression (Lefaucheur et al (2020)
But: There are few treatment places and most psychiatrists do not know the procedure, even though it is recommended in the treatment guidelines

Combining Ketamine infusions with rTMS and high-frequent psychotherapy

Ketamine leads to immediate improvement of symptoms and improves neuroplasticity
rTMS also improves neuroplasticity and leads to longer lasting antidepressive effects
Intensive psychotherapy (including hypnosis) benefits from the cognitive abilities improved by ketamine and rTMS and leads to long-lasting improvements

Ketamine facts

Ketamine is on the market since 1970 as a dissociative anesthetic
Ketamine is safe (ld 50 > factor 300 of therapeutic dose)
Ketamine has few side-effects and no irreversible side-effects
Ketamine has few contraindications: Uncontrolled hypertension, hyperthyroidism, intracranial pressure, severe heart failure, acute glaucoma, acute psychosis
Ketamine has a short half-time
No permanent intake of Ketamine is required: hit and go – effect
The effects of Ketamine are extremly fast (within hours)
Ketamine has fast anti-suicidal effects

“This is a game changer“ – John Krystal, MD, chief psychiatrist, Yale Medicine:

The drug works differently than those used previously, he notes, calling ketamine “the anti-medication” medication. “With most medications, like valium, the anti-anxiety effect you get only lasts when it is in your system. When the valium goes away, you can get rebound anxiety. When you take ketamine, it triggers reactions in your cortex that enable brain connections to regrow. It’s the reaction to ketamine, not the presence of ketamine in the body that constitutes its effects.”

How does ketamine work as depression treatment?

Mechanisms of action:

Blocks the NMDA receptor and inhibits it allosterically
Modulates and activates GABA A receptors of the α6β2δ and α6β3δ types.
Weak agonistic effect at opioid receptors
Inhibits reuptake of catecholamines at synaptic endplate
Inhibition of NMDA receptors in lateral habenula with disinhibition of downstream reward centres (likely responsible for immediate effect)
Micro RNAs expression of miR-29b-3p in the prefrontal cortex is increased, thereby positive effect on metabotropic glutamate receptor type 4
Metabolite hydroxynorketamine probably has its own antidepressant potency
Via glutamate AMPA receptor in the medial prefrontal cortex release of brain-derived neurotrophic factor

Increase in neuroplasticity

Chronic stress and depressive behaviours are associated in neuroscience research with impairments in neuroplasticity, such as neuronal atrophy and synaptic loss in the medial prefrontal cortex (mPFC) and hippocampus.
Ketamine increases connectivity and restores synaptic structures in the frontal brain and hippocampus

Ketamine administration is associated with the restoration of markers involved in molecular neuroplasticity, such as. Glutamate, AMPA (α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptors, mTOR (mechanistic target of rapamycin), BDNF (brain-derived neurotrophic factor), TrkB (tropomyosin receptor kinase B), VGF, eEF2K (eukaryotic elongation factor 2 kinase), p70S6K (p70 ribosomal S6 kinase), GSK-3 (glycogen synthase kinase 3), Erk, and microRNAs. M. Kang (2021)

Administration of Ketamine

All the effects during the administration disappear usually within 20 to 30 minutes after infusion
In few cases some effects can persist until the next day
The patient must always maintain a sense of control. In case of undesirable side effects, the drip rate is reduced or the infusion is temporarily stopped
The infusion must be administered in a quiet, safe environment
The patient must be able to communicate with the therapist at all times. Blood pressure and oxygen are continuously monitored

Immediate effects of ketamine infusions

Improvement of depressive symptoms on the next day, sometimes already during or shortly after the infusion.
Reduction or disappearance of suicidal thoughtsReduction in anxiety, compulsions and pain

These effects last for days to weeks, in rare cases even permanently.
Some patients experience significant effects after the first infusion, some patients require a series of up to six infusions, very rarely more.
We usually administer an infusion every second day, in severe cases initially daily. Longer intervals are also possible.

Possible side effects of ketamine infusions

Feeling of being drunk
Change in colour and shape perception, double vision
Change in body perception
Memorizing forgotten experiences
Eurphoria, silliness
Dreams, mild hallucinations
Feeling of merging with the environment
Increased sensitivity to sound
Nausea
Panic attacks due to the experience of dissociation
Increase in blood pressure

IV Ketamine Treatment or Esketamine nasal spray?

The patent on racemic ketamine has long expired. So intravenous ketamine for treatment of depression cannot be patented, and the pharmaceutical industry has therefore no incentive to undertake costly clinical trials to obtain a marketing permit. This is why it remains an off-label treatment

Esketamine nasal-spray was patented by Janssen and is approved for treatment resistant depression.

Esketamine nasal spray is less safe, less controllable and less effective than racemic ketamine – Bahji, Vazquez, Zarate (2021)

The price of esketamine nasal spray is about 500 euros per dose. It may only be given under inpatient conditions by healthcare professionals.

So the nasal spray is a good business!

What is Transcranial magnetic stimulation?

When a strong alternating magnetic field is directed on parts of the brain, the neurons are forced to depolarize. The magnetic field makes them release the neurotransmitters that regulate brain functions.
Unlike depression medications, TMS does not have systemic effects such as weight gain, sexual dysfunction, nausea, tremors, dry mouth, diarrhea, headaches, constipation, sweating, sleepiness or anxiety. It also does not generate any cognitive impairment that was observed in ECT treatment such as memory impairment and no anesthesia or muscle relaxant medication are needed.

1995 first studies about depression treatment with rTMS (George et al)
2008 FDA approved for patients with MDD who failed one medication

RTMS for depression treatment

A series of 20 stimulations 10 Hz over the left dorsolateral prefrontal cortex reduces robustly depressive symptoms
In patients with unipolar depression effects are the same or better than with pharmacotherapy. -Lefaucheur (2020)
Modern, more intensive treatment programs (Stanford Accelerated Intelligent Neuromodulation Therapy SAINT) show remission rates of almost 90% with 10 stimulations daily for 5 days -Cole et al (2020)
Effects sustain over months – Donse et al (2017)

How to target the correct stimulation area with rTMS:

Orientation to the scalp via anatomical calculation models are unreliable because there are large interindividual deviations in the exact position of the DLPFC.
MRI-guided neuronavigation is costly and does not necessarily provide a reliable additional benefit in terms of efficiency.
We use a neuro-cardiac-guided TMS that measures the effect of probatory stimulation on heart rate deceleration. – Iseger et al (2020)

Possible side effects of rTMS:

Rare and harmless:

Headache
Drowsiness

Extremely rare:

Seizures (usually in patients with pre-existing epilepsy)

EEG Neurofeedback Training for depression treatment

In EEG neurofeedback, EEG patterns are linked in real time with animations on a screen. Through operant conditioning, brain activities in certain areas can be strengthened or weakened. The procedure is non-invasive and safe.
Neurofeedback training is well established and proven effective for ADD/ADHD
There is certain evidence of the effectiveness of neurofeedback training in the treatment of depression (Barlas, 2021).

Studies on the combination with ketamine are not yet known.

Psychotherapy for depression treatment

There are hundreds of different psychotherapy methods.
Even in the application of the individual procedures, there are great differences in the training of the therapists and the implementation of the treatment. The intensity and frequency of application differs considerably. Treatments are carried out individually or in groups

There are therefore considerable methodological problems in comparing the effect of the procedures with regard to their effectiveness in depression.

Cognitive Behaviour Therapie (CBT) shows generally positive effects in the treatment of depression (Lopez et al, 2019)
Psychodynamic Therapy seems to have comparable effects to CMB (Steinert et al, 2017)
EMDR (eye-movement-desensitisation-and-reprocessing), a procedure developed for the treatment of trauma patients, also seems to be effective (Wood et al, 2018)
Hypnosis also seems to be effective (Milling et al, 2019)
Gestalt-Therapy seems to be effective, but not as effective as hypnosis (Gonzalez-Ramirez, 2017)

Combination rTMS and Ketamine for depression treatment

Combination therapy with transcranial magnetic stimulation and ketamine for treatment-resistant depression: A long-term retrospective review of clinical use (Best et al. 2019)

Ketamine therapy combined with repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder at a suburban tertiary clinic (Davila et al, 2021)

Various studies, not only for the treatment of depression, show clear evidence of a synergistic effect of rTMS and ketamine, as well as good tolerability and safety.

Combination Psychotherapy and Ketamine for depression treatment

Krupitsky E.M. & Grinenko, A.Y (1997) Ketamine psychedelic therapy The positive role of spiritual experiences for the treatment of alcohol dependence is reported here

Samuel Wilkinson (2018): Cognitive Behavior Therapy May Sustain Antidepressant Effects of Intravenous Ketamine in Treatment-Resistant Depression. Cognitive behaviour therapy (CBT) after i.v. ketamin-infusions

Raquel Bennett (2019): i.m. or sublingual Ketamine 0,5mg/kg leads to consolidation of psychological material in a psychotherapy. 1,0-2,0 mg/kg i.m. induces a psychedelic Ketamine journey. In both cases, ketamine is ultimately used as a kind of catalyst for psychotherapeutic processes

Dore, J et al (2019) Ketamine assisted psychotherapy (KAP): Patient demographics, clinical data and outcomes in three large practices administering ketamine with psychotherapy This article is the first to explore KAP within an analytical framework examining three distinct practices that use similar methods. Especially in elderly patients and patients with severe symptoms, lasting improvements are achieved.

Treatment concept for depression Dr. Scheib

In the practices Dr Scheib in Munich and Berlin and the clinic Dr. Scheib on Mallorca, we combine ketamine infusion therapy with intensive psychotherapy, hypnosis, magnetic stimulation (rTMS) and neurofeedback.

In addition, we offer – depending on the indication and location – sports therapy, physiotherapy, biofeedback and other relaxation methods.

At the beginning, an intensive psychiatric and psychological assessment takes place, including EEG and psychological test diagnostics. This is followed by a common therapy plan in which the individual elements are combined depending on the patient’s problems and resources.

On average, each patient receives between four and six ketamine infusions at intervals of one to two days. In addition, there are around 10 (sometimes more) hours of psychotherapy per week. 10, in special cases up to 50 units of rTMS per week, and additionally daily neurofeedback other relaxation procedures (depending on whether it is inpatient or outpatient treatment)

Follow-up survey 116 patients between April 2017 and February 2021:

26 patients responded

Age between 19 and 82 years

Average of two and a half years after treatment (3 to 49 months)

Average of 5 ketamine infusions (0.5mg/kg)

Ketamine only 19%, ketamine plus other procedures 81%

Additional psychotherapy 65%

Additional rTMS 35%

Additional neurofeedback 23%

If you are the caregiver for a person with dementia and feel overwhelmed, we can help. We will be happy to answer your questions personally:

For further information please feel free to contact us:

Contact Practice Dr. Scheib Munich:

Tel: +49 8945670607

E-mail: muenchen@psychosomatik.com

Contact Practice Dr. Scheib Berlin:

Tel: +49 30 634 28 891
E-mail: berlin@psychosomatik.com

Contact Clinic Dr. Scheib Mallorca:

Tel: +34 971 969 530
E-mail: mallorca@psychosomatik.com

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Data protection information according to Art. 13 DSGVO
Name and address of the responsible party
The responsible party within the meaning of the General Data Protection Regulation (DSGVO) and other data protection regulations is:

Private Practice Dr. Mario Scheib

Lützenstr, 3-4
10711 Berlin, Germany

Phone:
Berlin: +49 30 63428891
Munich: +49 89 45670607
E-mail: berlin@psychosomatik.com
muenchen@psychosomatik.com

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Facebook Connect

We use the Facebook Connect service on our website. The provider of the service is Meta Platform Ireland Limited (Marketplace), 4 Grand Canal Square Grand Canal Harbour Dublin 2, Ireland.

The use of the service may result in a data transfer to a third country (USA).

Further information can be found in the provider's data protection information at the following URL: https://de-de.facebook.com/policy.php.

Appointment booking
You have the option of making appointments with us directly on our website. If you enter the requested data and the desired date in the mask provided, our system will suggest free appointments. The data you enter (name, e-mail address and optionally telephone number) will be used by us for the planning, execution and, if necessary, follow-up of the appointment.

The processing of the data is based on the legal basis of consent (Art. 6 para. 1 lit. a DSGVO). As a website visitor, you have consented to the processing of your personal data with your voluntary, explicit consent given in advance. Without separate consent, the personal data will not be processed by us in the manner described above, provided that there is no other legal basis within the meaning of Art. 6 para.1 DSGVO on which we base the processing. We proceed in the same way if you revoke your consent. The lawfulness of the processing carried out until the revocation remains unaffected.

Jameda

We use the service Jameda on our website. The provider of the service is jameda GmbH, Balanstr. 71a, 81541 Munich, Germany.

Further information can be found in the provider's data protection information at the following URL: https://www.jameda.de/info/datenschutz.

Web fonts
This site uses so-called web fonts for the uniform display of fonts, which are provided by an external provider and loaded by the browser when the website is called up. In doing so, the provider of the web font becomes aware that our website has been accessed from your IP address, as your browser establishes a direct connection to the provider of the web font.

The processing of the data is based on the legal basis of consent (Art. 6 para. 1 lit. a DSGVO). As a website visitor, you have consented to the processing of your personal data with your voluntary, explicit consent given in advance. Without separate consent, the personal data will not be processed by us in the manner described above, provided that there is no other legal basis within the meaning of Art. 6 para.1 DSGVO on which we base the processing. We proceed in the same way if you revoke your consent. The lawfulness of the processing carried out until the revocation remains unaffected.

Google Fonts

We use the Google Fonts service on our website. The provider of the service is Google Ireland Ltd, Gordon House, Barrow Street Dublin 4, Ireland.

The use of the service may result in data transfer to a third country (USA).

Further information can be found in the provider's data protection information at the following URL: https://policies.google.com/privacy.

Websecurity
On our website we use tools that protect against unauthorized access, spam or other attacks. This increases the security of our website.

We base this processing on a legitimate interest (Art. 6 para. 1 lit. f DSGVO).

Our legitimate interest is to be able to guarantee the security of our website as well as to protect ourselves from unauthorized access, spam and other attacks.

hCaptcha

We use the hCaptcha service on our website. The provider of the service is Intuition Machines, Inc, 350 Alabama St, San Francisco, CA 94110, USA.

The use of the service may result in data transfer to a third country (USA).

Further information can be found in the privacy information of the provider at the following URL: https://www.hcaptcha.com/privacy.

Payment service provider
We integrate payment services of a company specialized in these services on our website. When you make a purchase from us, your payment data (e.g. name, payment amount, account details, credit card number) are transmitted to our payment service provider and processed by them for the purpose of payment processing. The contractual and data protection provisions of the provider selected by us apply to these transactions.

The processing of the data is based on the legal basis of consent (Art. 6 para. 1 lit. a DSGVO). As a website visitor, you have consented to the processing of your personal data with your voluntary, explicit consent given in advance. Without separate consent, the personal data will not be processed by us in the manner described above, provided that there is no other legal basis within the meaning of Art. 6 para.1 DSGVO on which we base the processing. We proceed in the same way if you revoke your consent. The lawfulness of the processing carried out until the revocation remains unaffected.

PayPal

We use the PayPal service on our website. The provider of the service is PayPal (Europe) S.à r.l. et Cie, S.C.A., 22-24 Boulevard Royal, L-2449, Luxembourg.

The use of the service may result in data transfer to a third country (USA).

Further information can be found in the provider's data protection information at the following URL: https://www.paypal.com/myaccount/privacy/privacyhub?locale.x=de_AT.

Contact form
On our website, you have the option of contacting us via a contact form. For contacting us via this form, your contact data in particular is required.

As a legal basis, reference is made here to processing for the purpose of contract performance or pre-contractual measures pursuant to Art. 6 (1) lit. b DSGVO. In addition, there may be a legitimate interest to maintain business relationships or to respond to your inquiry for other reasons.

In this case, the legal basis for processing your data would be Art. 6 (1) lit. f DSGVO.

The data will be deleted when we have conclusively answered your inquiry and no other retention obligations prevent this.

Telephone or e-mail contact
In accordance with legal requirements, we have provided a telephone number and e-mail address on our website. The data transmitted in these ways are automatically stored by us in order to process corresponding inquiries or to be able to contact the inquiring person. This data will not be passed on to third parties without our consent.

If contact is made by telephone or via our e-mail address for pre-contractual or contractual purposes, the processing of personal data is based on the legal basis of Art. 6 (1) lit. b DSGVO. For all other contacts on your part, the processing of personal data by us is based on our legitimate interest pursuant to Art. 6 (1) lit. f DSGVO.

Handling of applicant data
It is possible to send us an application (e.g. by mail, online application form or by e-mail). The personal data received as a result will be stored and processed by us for the application process.

The basis for the processing is Art. 6 (1) lit. b DSGVO as well as Art. 6 (1) lit. a DSGVO, provided that consent has been given. Insofar as German law is applicable, Section 26 BDSG in particular is used as the legal basis for processing. You can revoke your consent at any time. The lawfulness of the processing carried out until the revocation remains unaffected.

If an employment relationship results from the application, the collected data will be stored for the processing of the employment relationship on the basis of Art. 6 (1) lit. b DSGVO. Insofar as no employment relationship results, the data will be stored on the basis of Art. 6 para.1 lit. f DSGVO for the duration of legal claims, in particular due to discrimination in the application process. This is necessary for the defense against any lawsuits or accusations. If consent has been given, the data will be stored longer on the basis of Art. 6 para. 1 lit. a DSGVO. You can revoke your consent at any time. The lawfulness of the processing carried out until the revocation remains unaffected.

If no employment relationship is established, the person applying may be included in our applicant pool. In this case, all details of the application are stored in order to be able to contact the relevant person in the event of suitable job vacancies.

The storage of data in the applicant pool takes place exclusively after consent has been given on the basis of Art. 6. para. 1 lit. a DSGVO. This consent can be revoked at any time, whereupon the corresponding data will be deleted, unless there are legal reasons for retention. Deletion takes place automatically no later than two years after consent has been given. The lawfulness of the processing carried out until the revocation remains unaffected.

Applicant pool
If no employment relationship is established, the applicant can be included in our applicant pool. In this case, all details of the application are stored in order to be able to contact the corresponding person in the event of suitable job postings.

The storage of data in the applicant pool takes place only after consent has been given on the basis of Art 6. para.1 lit.a DSGVO. This consent can be revoked at any time, whereupon the corresponding data will be deleted, unless there are legal reasons for retention. Deletion will take place no later than two years after the consent was given. The lawfulness of the processing carried out until the revocation remains unaffected.

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