Method of diagnosing, treating and educating individuals with and/or about depression

• US 20060150989A1
• Filed: 01/12/2005
• Published: 07/13/2006
• Est. Priority Date: 01/12/2005
• Status: Abandoned Application

• Current Assignee: Peter Migaly
• Original Assignee: Peter Migaly
• Inventors: Migaly, Peter
• Application Number:
  US11/034,447
• Publication Number:
  US 20060150989A1
• Time in Patent Office: Days
• US Class Current: 128/898
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety

Abstract

The present invention relates to methods of correcting misconceptions in the DSM, which can affect improved diagnosis and testing for depression, resulting in better patient satisfaction and global improvement. Also provided are methods comprising administering various medications to produce a “pseudo-placebo” effect in depression, which can guide in selecting a particular treatment method for a more effective antidepressant effect. Another aspect of the invention relates to clinical neuroplasticity in depression by providing a method that increases patient compliance with medication, decreases the bias or prejudice in the public against depression/mental illness, decreases the percentage of treatment resistant depression, decreases patients'"'"' resistance and inappropriate use of less effective treatment or treatment without medication because of the existing misperception. Similar methods also can be used successfully for other conditions where depressive symptoms are often present as coexisting condition, such as nicotine addiction, smoking cessation, overweight/weight control and pain management.

Claims

1. A method of diagnosing and treating a depressive disorder in a patient, comprising challenging the traditional dogma of the Diagnostic and Statistical Manual IV-TR, which has set the current standard of care with it'"'"'s criteria sets, as being only a differential diagnostic manual primarily useful for differentiating depression from other mental disorders;

challenging that the Diagnostic and Statistical Manual IV-TR'"'"'s limited number of depressive symptoms in it'"'"'s criteria set is accurate and sensitive enough to diagnose, monitor and test for depressive symptoms and accurate and sensitive enough to test for remission of depressive symptoms, said limited number of depressive symptoms consisting of depressed mood, decreased sleep, decreased interest, guilt, decreased energy, decreased concentration, decreased appetite, psychomotor retardation and suicidal ideation; and

challenging that the Hamilton Depression Rating Scale or equivalent scale(s), which rating scale relies on the Diagnostic and Statistical Manual IV'"'"'s limited number of depressive symptom list, is accurate and sensitive enough to diagnose, monitor and test for depressive symptoms and accurate and sensitive enough to test for remission of depressive symptoms, by providing an extended list of depressive symptoms that is accurate and sensitive enough and that can be systematically relied upon to diagnose, test and monitor for depressive symptoms, said extended list selected from the group consisting of anxiety, somatic concerns/somatization/focusing on somatic symptoms, rumination/obsessiveness, anger/irritability/impulsivity/hostility/violence, cognitive distortion/global thinking, cognitive deficit/impairment, social withdrawal, helplessness/hopelessness, acute and chronic stressors and the patient'"'"'s ability to cope with them and to problem solve, perception of unjust and resentment, indifference, sensitivity, and other symptoms and observed signs.

2. The method of claim 1, further comprising producing a pseudo-placebo effect that results in conditioning and expectation changes in the patient that are relied on and utilized to treat the depression in the patient, wherein the pseudo-placebo effect is comprised of targeting each or any of the of the depressive symptoms, which include the extended symptom list, and not only the general depressed mood itself, with psychological and/or pharmacological intervention.

3. The method of claim 1, wherein said method increases the effectiveness of the treatment of depression, provides a quicker response to treatment, provides a better chance to achieve full remission and increases the patients'"'"' quality of life, thus decreasing the risk of suicide.

4. The method of claim 1, wherein percentage of cases of treatment resistance depression and percentage of cases of depression only in partial remission are decreased in the population of patients afflicted with depression.

5. The method of claim 2, wherein examples for the pseudo-placebo effect utilizing a pharmacological treatment is selected from the group of antidepressants selected from the group consisting of serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, combined action SSRI/SNRI, serotonin-2 antagonist/reuptake inhibitors, antidepressants with alpha-2 antagonism plus serotonin-2 and serotonin-3 antagonism, antidepressants with serotonin/norepinephrine/dopamine reuptake inhibition and antidepressants with norepinephrine and dopamine reuptake inhibition;

and/or said antidepressants are selected from the group consisting of tricyclic antidepressants, tetracyclic antidepressants and MAOI inhibitors; and

/or said antidepressants are selected from the group consisting of 5-HT-lalpha antagonists, 5-HT-1beta antagonists, 5-HT1A receptor agonists, 5-HT1A receptor agonists and antagonists, 5-HT2 receptor antagonists, viloxazine hydrochloride, dehydroepiandosterone, NMDA receptor antagonists, AMPA receptor potentiators, substance P antagonists/neurokinin-1 receptor antagonists, nonpeptide Substance P antagonists, neurokinin 2 antagonists, neurokinin 3 antagonists, corticotropin-releasing factor receptor antagonists, antiglucocorticoid medications, glucocorticoid receptor antagonists, cortisol blocking agents, nitric oxide synthesize inhibitors, inhibitors of phosphodiesterase, enkephalinase inhibitors, GABA-A receptor agonists, free radical trapping agents, atypical MAOI'"'"'s, selective MAOI inhibitors, hormones, folinic acid, leucovorin, tramadol, tryptophan and pharmaceutically acceptable salts thereof; and

/or said antidepressant includes clomipramine; and

/or wherein the antidepressants are selected from the group consisting of fluoxetine, norfluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, bupropion, nefazodone, mirtazapine, venlafaxine, duloxetine, milnacipran, reboxetine, zimelidine, indalpine, gepirone, femoxetine, alaproclate, duloxetine and pharmaceutically acceptable salts thereof;

or wherein examples for the pseudo-placebo effect utilizing a pharmacological treatment includes atypical antipsychotics and/or dopamine system stabilizers, and/or antipsychotics selected from the group consisting of risperidone, quetiapene, olanzapine, ziprasidone and aripiprazole, wherein said atypical antipsychotics are selected from the group consisting of olanzapine, iloperidone, Org 5222, melperone, amperozide, SM-9018, JL-13 and pharmaceutically acceptable salts thereof;

or wherein said antipsychotics are selected from the group consisting of perphenazine, trifluoperazine, zotepine, flupenthixol, amisulpride, and sulpiride;

or wherein examples for the pseudo-placebo effect utilizing a pharmacological treatment includes anxiolytics selected from the group consisting of clonazepam, benzodiazepines, antipsychotics, atypical antipsychotics and/or dopamine system stabilizers;

or wherein examples for the pseudo-placebo effect utilizing a pharmacological treatment includes medications targeting decreased or disturbed sleep with sleeping pills selected from the group consisting of zolpidem and benzodiazepines, as well as with targeting sleep problems through sleep hygiene, correcting sleep apnea with continuous positive airway pressure (CPAP), or correcting overweight;

or wherein examples for the pseudo-placebo effect utilizing a pharmacological treatment includes medications targeting anger/violence/anxiety such as the beta blockers propranolol or pindolol;

or wherein examples for the pseudo-placebo effect utilizing a pharmacological treatment includes medications targeting fatigue and tiredness, like modafinil, or wherein examples for the pseudo-placebo effect utilizing a pharmacological treatment includes medications targeting decreased energy, such as stimulants, or wherein examples for the pseudo-placebo effect utilizing a pharmacological treatment includes medications that target disorders selected from the group consisting of obsessiveness/rumination, cognitive distortions, jumping to conclusion, somatic symptoms and perceptual disturbance relating to somatic symptoms, and wherein examples for the pseudo-placebo effect utilizing a pharmacological treatment includes any of the pharmacological treatments or combinations thereof that are known to target these symptoms are utilized.

6. The method of claim 1, wherein a psychological test comprised of a psychometric instrument incorporates the extended symptom list that is systematically relied upon.

7. The method of claim 6, wherein the extended symptom list comprises at least five extended symptoms.

8. The method of claim 6, wherein the extended symptom list comprises at least six extended symptoms.

9. The method of claim 6, wherein the extended symptom list comprises at least seven extended symptoms.

10. The method of claim 6, wherein the extended symptom list comprises at least eight extended symptoms.

11. The method of claim 6, wherein the psychological test comprised of a psychometric instrument that is based on the more extended symptom list provides a more sensitive method to test and monitor depression than existing tests and provides a more practical way to better test antidepressant effectiveness and to test which antidepressant or combination thereof is more effective and/or quicker acting.

22. The method of claim 5, wherein the pseudo-placebo effects of the medication(s) and/or their increased effectiveness targeting more than one depressive symptoms protects against or remedies the development of tolerance towards antidepressant treatment, SSRI treatment, and/or wherein that prevents a paradoxical effect of the antidepressant treatment or SSRI treatment that sensitizes patients to depression, avoids or treats worsening of depression from the antidepressant treatment, or SSRI treatment, treats residual symptoms of depression, and/or decreases suicide and/or the risk of suicide.

23. The method of claim 22, wherein treatment is given as initial treatment or as soon as possible, or upon presentation to a physician or a health care provider for preventing suicide.

24. The method of claim 1 further comprising educating or marketing to the patients or to the public of treatment strategies and/or treatment alternatives as it pertains to the pseudo-placebo/conditioning effects of medications on the treatment of depression.

25. The method of claim 1 further comprising educating the patients or to the public on the misconception of the limited number of symptom list in Diagnostic and Statistical Manual IV-TR'"'"'s criteria set and/or of treatment strategies and/or treatment alternatives arising from that as of targeting the depressive symptoms other than the mood, and utilizing the pseudo-placebo/conditioning effects of medications in the treatment of depression.

12. A method of increasing treatment adherence and decreasing resistance for seeking help in a depressed patient as well as decreasing or eliminating prejudice and the stigma against depression as a mental illness, comprising describing to the patient, as well as to health care providers and to the general public, about clinical studies that do not pertain directly to mental depression involving neuroplasticity of the brain, neurogenesis, and/or brain mapping, wherein that is linked to neuroplasticity in the brain and mental depression and/or brain mapping in depression with a description of a metaphor.

18. The method of claim 12, wherein the link is made to the patient, health care providers and to the general public that the hippocampal volumetric and/or morphologic changes seen in depression may result from the process of learning and/or memory because learning is involved in the process of mental depression, rather than resulting from the change of mood per se, and wherein this new way of understanding the reasons for hippocampal changes in depression fits in well with findings that the hippocampus is involved in learning and memory, which may guide pre-clinical research for new antidepressants.

13. The method of claiml2, wherein the description comprises as if/role play experiments that cause depression or lift depression and/or environmental situations that could cause depression in anybody.

26. The method of claim 13 further comprising educating the patients or to the public that the clinical neuroplasticity explanation of depression may shift the focus off the neurotransmitter deficit explanation of depression, and/or the serotonin'"'"'s direct effect on the mood, and shifting the focus to the importance of targeting the various depressive symptoms other than the mood.

14. The method of claiml3, wherein the resolution of these environmental situations or as if/role play experiments are linked to the resolution of depressive symptoms with accompanied neuroplasticity.

15. The method of claiml2, wherein the linking to mental depression and neuroplasticity pertains to clinical neuroplasticity.

16. The method of claiml2, wherein the metaphors are selected from the group consisting of an “

invisible mitt”

being equivalent to restraining negative thought patterns/rumination with medications and/or with cognitive therapy;

the metaphor of practice or practice makes a master, which is a metaphor of practicing the equivalent of turning of dominos in the physical therapy of stroke victims, which is equivalent to the practice of cognitive therapy;

the metaphor of the need for practicing having optimistic thoughts, which can result from increasing positive expectations;

the metaphor of that six hours a day practice was needed for stroke victims therefore in the treatment of depression one hour of practice or psychotherapy per week or even per day may not be enough to counter the old habit/depressive thinking, so the “

invisible mitt/medication(s) and/or diligent homework practice is needed;

the metaphor to explain of why it is so easy to relapse if one stops the invisible mitt/medication and/or the practice; and

using the description and examples of pseudo-placebo conditioning/expectation changing effects of medications on depression to describe various treatment strategies/alternatives for the treatment of depression, or that why antidepressants have a large placebo effect.

17. The method of claim 16, wherein the metaphor may be used to explain the risk of relapse to depression if the medications are discontinued, or if the patterns of thoughts are shifted again from predominantly positive to negative/ruminative thoughts.

19. A method of increasing treatment adherence and decreasing resistance for seeking help in a depressed patient, comprising:

meeting the client needs by the healthcare provider;

the healthcare provider changing his/her approach repeatedly so that the client'"'"'s needs are met and a desired change occurs, wherein the patient perceives a gain, that the situation is right and has a readiness for change;

that the timing for change is perceived as the right time, that the need for change being important and emergent enough be realized, that the relative easiness of the change or that the process of change can come with at least some enjoyment and satisfaction can be realized, and that the situation is adjusted so that the patient would have the tools and skills needed for the desired change.

20. The method of claim 19, further comprising:

describing to the patient new information in simple ways so as to make them feel as if they already knew that information, thus relating to the information and/or accepting the information as their own;

eliciting positive emotions expectations from the patient;

validating the patient'"'"'s feelings through universal human experiences;

raising hope and/or increasing confidence in the patient;

giving the patient new, direct, personal experience that change is possible; and

acknowledging that rapid change is possible, wherein the patient, as well as health care providers and the general public are educated via marketing techniques of this method.

21. The method of claim 19, wherein the method can be used in cases other than depression, such as diagnostic categories where depression is often a co-morbid and/or underlying condition, and wherein the cases are selected from the group consisting of smoking-cessation, nicotine withdrawal, addiction, overweight/obesity/weight control, eating disorders, chronic pain, other mental disorders, and in other cases not related to depression.,

27. A method of diagnosing and treating a depressive disorder in a patient comprising administering a psychopharmacological diagnostic/treatment/educational modality to the patient, comprising:

a) assessing the presence and severity of a constellation of symptoms in the patient;

b) administering in therapeutic amounts at least one or more psychoactive drugs to the patient, wherein the at least one or more psychoactive drugs are selected based on the results of (a) so as to target the symptoms that are present;

c) educating the patient as to the neuroplasticity response of the brain that is ubiquitous to any human, wherein said education reduces negative feelings of the patient;

d) meeting the patient'"'"'s needs, wherein said meeting of the patient'"'"'s needs increases positive feelings in the patient;

e) reassessing at a later time the presence and severity of the constellation of symptoms in the patient;

f) adjusting the therapeutic amounts of the at least one or more psychoactive drugs based on the results of (e);

g) administering the adjusted therapeutic amounts of the at least one or more psychoactive drugs to the patient; and

h) repeating steps (c) through (g) until the presence and severity of the constellation of symptoms have diminished to a subclinical level.

28. The method of claim 27, wherein the constellation of symptoms include the presence of at least five or more of the following symptoms from (a), wherein one of the symptoms is either depressed mood or loss of interest or pleasure, as well as the presence of five or more of the following symptoms from (b):

depressed mood;

diminished interest or pleasure in all or almost all activities;

significant weight loss when not dieting or weight gain, or decrease or increase in appetite;

insomnia or hypersomnia;

psychomotor agitation or retardation, fatigue or loss of energy;

feelings of worthlessness or excessive or inappropriate guilt;

diminished ability to think or concentrate, or indecisiveness;

or suicidal ideation; and

anxiety, irritability, obsessiveness/rumination;

anger, helplessness/hopelessness;

impulsivity;

hostility;

violent behavior;

resentment;

excessive emotional sensitivity;

indifference;

cognitive distortion;

or social withdrawal.

29. The method of claim 27, wherein the depressive disorder is selected from the group consisting of major depressive disorder, dysthymic disorder, dual depression, depressive disorder not otherwise specified, substance/alcohol induced mood disorder, postpartum depression and adjustment disorder with depressed mood.

30. The method of claim 27, wherein the psychoactive drug is an antidepressant drug.

31. The method of claim 30, wherein the antidepressant drug is selected from the group consisting of serotonin reuptake inhibitors, a selective norepinephrine reuptake inhibitors, combined action SSRI/SNRI, serotonin-2 antagonist/reuptake inhibitors, an antidepressant with alpha-2 antagonism plus serotonin-2 and serotonin-3 antagonism, an antidepressant with serotonin/norepinephrine/dopamine reuptake inhibition and an antidepressant with norepinephrine and dopamine reuptake inhibition.

32. The method of claim 27, wherein the psychoactive drug is an antipsychotic drug.

33. The method of claim 32, wherein the antipsychotic drug is selected from the group consisting of quetiapine, risperidone, ziprasidone, olanzapine, iloperidone, Org 5222, melperone, amperozide, SM-9018, JL-13, aripiprazole and pharmaceutically acceptable salts thereof.

34. The method of claim 32, wherein the antipsychotic drug is selected from the group consisting of perphenazine, trifluoperazine, zotepine, flupenthixol, amisulpride and sulpiride.

35. The method of claim 27, wherein the psychoactive drug is selected from the group consisting of clonazepaam, a benzodiazepine, zolpidem, propranolol, pindolol, modafinil and duloxetine.

36. The method of claim 27, wherein the negative feelings that are reduced in the patient are selected from the group consisting of self-blaming, shame, guilt, helplessness, hopelessness, unhappiness, melancholia, discouragement, sorrow, gloominess, miserableness, torment and feelings of being stigmatized because of the depressive disorder.

37. The method of claim 27, wherein the positive feelings that are increased in the patient are selected from the group consisting of hopefulness, satisfaction, expectation of successful changes, happiness, contentment, comfortableness, pleasure, joy, peace, harmony, cheerfulness, euphoria, ecstasy, delight, gratefulness and wellness.

38. The method of claim 27, wherein the patient'"'"'s needs that are met are selected from the group consisting of unconditional acceptance, appreciation, praise, understanding, concern, patience and limit setting.

39. The method of claim 27, wherein educating the patient as to the neuroplasticity response of the brain improves compliance of the patient to treatment.

40. A method of producing a pseudo-placebo effect in a patient afflicted with a depressive disorder in order to produce rapid global improvement of symptoms and satisfaction in the patient, comprising:

targeting one or more specific symptoms of the patient which are known to respond quickly to drug administration; and

administering in therapeutic amounts at least one or more psychoactive drugs known to affect the one or more specific symptoms targeted, wherein alleviation of one or more symptoms elicits a conditioned reflex in the patient which results in a rapid global improvement of other symptoms of the patient, thus increasing patient satisfaction and further positive changes in the patient.

41. The method of claim 40, wherein the one or more symptoms of the patient are selected from the group consisting of anxiety;

helplessness/hopelessness;

insomnia;

fatigue;

obsessiveness/rumination;

anger/violence;

cognitive distortions and perceptual/somatic disturbance.

42. The method of claim 40, wherein the one or more psychoactive drugs include antidepressants, antipsychotics, anxiolytics, sedatives or beta blockers.

43. The method of claim 40, wherein anxiety is treated with antipsychotics, clonazepam or benzodiazepines;

helplessness/hopelessness is treated with antipsychotics;

insomnia is treated with sedatives, such as zolpidem or antipsychotics;

anxiety is treated with anxiolytics;

anger and violence is treated with antipsychotics, anger, violence and anxiety are treated with beta blockers, such as propranolol or pindolol;

fatigue is treated with modifinil;

obsessiveness/rumination is treated with SSRIs and/or a combination of antipsychotics/antidepressants;

cognitive distortions are treated with antipsychotics;

somatic/perceptual disturbance is treated with antipsychotics and/or antidepressants; and

social withdrawal is treated with antidepressants and/or antipsychotics.

44. The method of claim 40, wherein the one or more of the psychoactive drugs are selected from the group consisting of clonazepam, a benzodiazepine, zolpidem, propranolol, pindolol, modafinil and duloxetine.

45. A method of improving patient compliance in the treatment of an already-diagnosed depressive disorder, comprising:

educating the patient as to the neuroplasticity response of the brain that is ubiquitous to any human, wherein said education reduces negative feelings of the patient;

assessing the patent for the reduction of negative feelings; and

promptly administering to the patient a psychoactive drug designed to address the patient'"'"'s symptoms of the depressive disorder.

46. The method of claim 45, wherein the negative feelings that are reduced in the patient are selected from the group consisting of self-blaming, shame, guilt, helplessness, hopelessness, unhappiness, melancholia, discouragement, sorrow, gloominess, miserableness, torment and feelings of being stigmatized by others because of the depressive disorder.

47. The method of claim 45, wherein the psychoactive drug is an antidepressant drug.

48. The method of claim 47, wherein the antidepressant drug is selected from the group consisting of serotonin reuptake inhibitors, a selective norepinephrine reuptake inhibitors, combined action SSRI/SNRI, serotonin-2 antagonist/reuptake inhibitors, an antidepressant with alpha-2 antagonism plus serotonin-2 and serotonin-3 antagonism, an antidepressant with serotonin/norepinephrine/dopamine reuptake inhibition and an antidepressant with norepinephrine and dopamine reuptake inhibition.

49. The method of claim 45, wherein the psychoactive drug is an antipsychotic drug.

50. The method of claim 49, wherein the antipsychotic drug is selected from the group consisting of quetiapine, risperidone, ziprasidone, olanzapine, iloperidone, Org 5222, melperone, amperozide, SM-9018, JL-13, aripiprazole and pharmaceutically acceptable salts thereof.

51. The method of claim 49, wherein the antipsychotic drug is selected from the group consisting of perphenazine, trifluoperazine, zotepine, flupenthixol, amisulpride and sulpiride.

52. The method of claim 45, wherein the psychoactive drug is selected from the group consisting of clonazepam, a benzodiazepine, zolpidem, propranolol, pindolol, modafinil and duloxetine.