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Protocol - Antipsychotic Medication Extrapyramidal Side Effects

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Description:

The Extrapyramidal Symptom Rating Scale (ESRS) is a clinician-administered rating scale that includes four subscales and four Clinical Global Impression Severity (CGI-S) scales. The four subscales include drug-induced movement disorders (12-item questionnaire rated on a 4-point scale), parkinsonism and akathisia (7-item examination rated on a 7-point scale), dystonia (10-item examination rated on a 7-point scale), and dyskinesia (7-item examination rated on a 7-point scale). The four clinical global impression severity scales capture tardive dyskinesia, parkinsonism, dystonia, and akathisia and are rated according to the clinician’s experience using an 8-point rating scale.

Specific Instructions:

None

Protocol:

Extrapyramidal Symptom Rating Scale (ESRS)

Summary of the ESRS examination procedure

1. Patient is asked to remove their shoes (omitted if judged clinically inappropriate or when patient hesitates, or delayed after patient has walked (after # 7). The patient is asked to remove anything from their mouth (except dentures). The patient is asked to sit facing the examiner on a chair with no armrests.

2. Observe facial expressiveness, speech, and dyskinesia while completing the questionnaire and while completing items 4, 5, and 6 below.

3. Patient is asked to extend both arms forward, with palms down and eyes closed.

4. The patient is asked to carry out pronation and supination of both hands as fast as possible, and to perform rapid alternate movements of both wrists. Repeat as necessary.

5. While the patient sits facing the examiner on a chair with no armrests about 1 foot (approx. 30 cm) from a table with his upper body turned, the patient is asked to copy a spiral with each hand and to write the name of his town, province/state and country.

6. Patient is asked to walk a distance of 12-15 feet (4-5 m) away from, and then back towards the examiner. Repeat as necessary.

7. Patient is asked to stand erect with eyes open with feet slightly apart (1-2 cm). The examiner pushes the patient on each shoulder, the back and pushes the chest or pulls from the back while asking the patient to keep his balance.

8. Carry out the examination of the muscular tonus of the four limbs.

In case of doubt score the lesser severity.

I. QUESTIONNAIRE: Parkinsonism, Akathisia, Dystonia and Dyskinesia. In this questionnaire, take into account the verbal report of the patient on the following: 1) the duration of the symptom during the day; 2) the number of days where the symptom was present during the last week; and, 3) the evaluation of the intensity of the symptom by the patient.

Enquire into the status of each symptom and rate accordingly

Absent

Mild

Moderate

Severe

1. Impression of slowness or weakness, difficulty in carrying out routine tasks

0

1

2

3

|__|

2. Difficulty walking or with balance

0

1

2

3

|__|

3. Stiffness, stiff posture

0

1

2

3

|__|

4. Restless, nervous, unable to keep still

0

1

2

3

|__|

5. Tremors, shaking

0

1

2

3

|__|

6. Oculogyric crisis, abnormal sustained posture

0

1

2

3

|__|

7. Abnormal involuntary movements (dyskinesia) of tongue, jaw, lips, face, extremities or trunk

0

1

2

3

|__|

II. EXAMINATION: PARKINSONISM AND AKATHISIA

Items based on physical examinations for Parkinsonism

Occasional

Frequent

Constant or Almost So

1. Tremor

None:

0

Right upper limb

|__|

Borderline:

1

Left upper limb

|__|

Small amplitude:

2

3

4

Right lower limb

|__|

Moderate amplitude:

3

4

5

Left lower limb

|__|

Large amplitude:

4

5

6

Head |__|

Jaw/chin |__|

Tongue |__|

Lips |__|

2. Bradykinesia

0

normal

1

global impression of slowness in movements

2

definite slowness in movements

3

very mild difficulty in initiating movements

|__|

4

mild to moderate difficulty in initiating movements

5

difficulty in starting or stopping any movement, or freezing on initiating voluntary act

6

rare voluntary movement, almost completely immobile

3. Gait & posture

0

normal

1

mild decrease of pendular arm movement

2

moderate decrease of pendular arm movement, normal steps

3

no pendular arm movement, head flexed, steps more or less normal

|__|

4

stiff posture (neck, back) small step (shuffling gait)

5

more marked, festination or freezing on turning

6

triple flexion, barely able to walk

4. Postural Stability

0

normal

1

hesitation when pushed but no retropulsion

2

retropulsion but recovers unaided

3

exaggerated retropulsion without falling

|__|

4

absence of postural response would fall if not caught by examiner

5

unstable while standing, even without pushing

6

unable to stand without assistance

5. Rigidity

0

normal muscle tone

Right upper limb

|__|

1

very mild, barely perceptible

Left lower limb

|__|

2

mild (some resistance to passive movements)

Right lower limb

|__|

3

moderate (definite difficulty to move the limb)

Left lower limb

|__|

4

moderately severe (moderate resistance but still easy to move limb)

5

severe (marked resistance with definite difficulty to move the limb)

6

extremely severe (limb nearly frozen)

Items based on overall observation during examination for Parkinsonism

6. Expressive automatic movements (Facial mask/speech)

0

normal

1

very mild decrease in facial expressiveness

2

mild decrease in facial expressiveness

3

rare spontaneous smile, decrease blinking, voice slightly monotonous

|__|

4

no spontaneous smile, staring gaze, low monotonous speech, mumbling

5

marked facial mask, unable to frown, slurred speech

6

extremely severe facial mask with unintelligible speech

7. Akathisia

0

absent

1

looks restless, nervous, impatient, uncomfortable

2

needs to move at least one extremity

3

often needs to move one extremity or to change position

|__|

4

moves one extremity almost constantly if sitting, or stamps feet while standing

5

unable to sit down for more than a short period of time

6

moves or walks constantly

III. Examination: DYSTONIA

Based on examination and observation

Acute torsion, and non-acute or chronic or tardive dystonia

0

absent

Right upper limb

|__|

1

very mild

Left upper limb

|__|

2

mild

Right lower limb

|__|

3

moderate

Left lower limb

|__|

4

moderately severe

Head |__|

Jaw/chin |__|

5

severe

Tongue |__|

Lips |__|

6

extremely severe

Eyes |__|

Trunk |__|

IV. EXAMINATION: DYSKINETIC MOVEMENT

Based on examination and observation

Occasional*

Frequent**

Constant or Almost So

1. Lingual movements (slow lateral or torsion movement of tongue)

none:

0

borderline:

1

clearly present, within oral cavity:

2

3

4

with occasional partial protrusion:

3

4

5

with complete protrusion:

4

5

6

|__|

2. Jaw movements (lateral movement, chewing, biting, clenching)

none:

0

borderline:

1

clearly present, small amplitude:

2

3

4

moderate amplitude:

3

4

5

but without mouth opening:

large amplitude:

4

5

6

|__|

with mouth opening:

3. Bucco-labial movements (puckering, pouting, smacking, etc.)

none:

0

borderline:

1

clearly present, small amplitude:

3

3

4

moderate amplitude, forward movement of lips:

4

4

5

large amplitude; marked, noisy smacking of lips:

5

5

6

|__|

4. Truncal movements (involuntary rocking, twisting, pelvic gyrations)

none:

0

borderline:

1

clearly present, small amplitude:

2

3

4

moderate amplitude:

3

4

5

greater amplitude:

4

5

6

|__|

5. Upper extremities (choreoathetoid movements only: arms, wrists, hands, fingers)

0

none:

0

borderline:

1

clearly present, small amplitude, movement of one limb:

2

3

4

moderate amplitude, movement of one limb or movement of small amplitude involving two limbs:

3

4

5

greater amplitude, movement involving two limbs:

4

5

6

|__|

6. Lower extremities (choreoathetoid movements only: legs, knees, ankles, toes):

none:

0

borderline:

1

clearly present, small amplitude, movement of one limb:

2

3

4

moderate amplitude, movement of one limb or movement of small amplitude involving two limbs:

3

4

5

greater amplitude, movement involving two limbs:

4

5

6

|__|

7. Other involuntary movements (swallowing, irregular respiration, frowning, blinking, grimacing, sighing, etc.)

none:

0

borderline:

1

clearly present, small amplitude:

2

3

4

moderate amplitude:

4

4

5

greater amplitude:

5

5

6

|__|

Specify...……………………………………………………………………………………………………………..

* when activated or rarely spontaneous

** frequently spontaneous and present when activated

V. CLINICAL GLOBAL IMPRESSION OF SEVERITY OF DYSKINESIA

Considering your clinical experience, how severe is the dyskinesia at this time?

0: absent

3: mild

6: marked

1: borderline

4: moderate

7: severe

2: very mild

5: moderately severe

8: extremely severe

VI. CLINICAL GLOBAL IMPRESSION OF SEVERITY OF PARKINSONISM

Considering your clinical experience, how severe is the parkinsonism at this time?

0: absent

3: mild

6: marked

1: borderline

4: moderate

7: severe

2: very mild

5: moderately severe

8: extremely severe

VII. CLINICAL GLOBAL IMPRESSION OF SEVERITY OF DYSTONIA

Considering your clinical experience, how severe is the dystonia at this time?

0: absent

3: mild

6: marked

1: borderline

4: moderate

7: severe

2: very mild

5: moderately severe

8: extremely severe

VIII. CLINICAL GLOBAL IMPRESSION OF SEVERITY OF AKATHISIA

Considering your clinical experience, how severe is the akathisia at this time?

0: absent

3: mild

6: marked

1: borderline

4: moderate

7: severe

2: very mild

5: moderately severe

8: extremely severe

Scoring:

Questionnaire for Parkinsonism, akathisia, dystonia and dyskinesia:

  • Each item is rated on a four point scale (0 = absent; 3 = severe). For subjective extra-pyramidal symptoms, severity is assessed over the last seven days and persistent symptoms are rated for the most typical day over the last seven.

Examination for Parkinsonism and akathisia (subscale II):

  • Tremors and rigidity are scored on a seven-point scale (0 = none; 6 = severe) for each body part. Ratings for tremors account for amplitude and number of times the movement occurs during the interview.
  • Total scores range from 0-102.
  • A score of 3 or greater on any of the items is required to establish Parkinsonism for initiation of anti-Parkinsonism treatment.
  • A score of 2 on 2 items or a score of 3 or greater on one item is required to establish the presence of Parkinsonism.
  • Hypokinesia subscale scores (ranging from 0-42) are calculated from gait and posture, rigidity, expressive automatic movements, and bradykinesia.
  • Hyperkinesia subscale scores (ranging from 0-54) are calculated from tremor and akathisia items.

Examination for dystonia:

  • Acute and chronic movements are scored on a seven point scale (0 = none; 6 = most severe). Each body part is rated separately.
  • Dystonia scores range from 0-60 and includes both acute and chronic dystonia.
  • A score of three or greater on at least one item or a score of 2 on 2 items is required for presence of dystonia.

Examination for dyskinesia:

  • Movements are scored on a seven-point scale (0 = none; 6 = severe) for each body part. Ratings account for amplitude and number of times the movement occurs during the interview.
  • Dyskinesia scores range from 0-42 and is the total of all seven items.
  • A score of three or greater on at least one item or a score of 2 on 2 items is required for presence of dyskinesia.
  • Tardive dyskinesia subscale scores for each item separately
  • Buccal-lingual-masticatory subscale is the total (0-18) from items 1, 2, 3 and an extremities score (0-12) from items 5 and 6.

Total Score:

  • A total DMID score can be derived by adding together all 41 items.

Clinical global impressions of severity of Parkinsonism, akathisia, dystonia, and tardive dyskinesia:

  • Results are rated according to results of the subjective questionnaire, examination subscales, and the evaluator’s clinical experience by applying an 8-point rating (0: absent; 1: borderline; 2: very mild; 3: mild; 4: moderate; 5: moderately severe; 6: marked; 7: severe; 8: extremely severe).
  • The 4 clinical global impressions of severity subscales are analyzed as separate items.

Chouinard © 1979

Protocol Name from Source:

Extrapyramidal Symptom Rating Scale (ESRS)

Availability:

Publicly available

Personnel and Training Required

The interviewer must be trained to and found competent to conduct motor examinations as well as be competent to recognize the impact of comorbidities (such as stroke, arthritis, psychosis, schizophrenia, etc.) on motor movements. Additionally, the interviewer must be trained and found competent in the recognition of motor movements and ratings listed in this protocol, such as the signs and degree of tremor and rigidity and the presence of bradykinesia/hypokinesia.

Equipment Needs

None

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training Yes
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual Yes
Mode of Administration

Clinician administered physical assessment and questionnaire

Life Stage:

Adult

Participants:

Adults, ages 18 years and older

Selection Rationale

The Extrapyramidal Symptom Rating Scale (ESRS) is a widely used, reliable, and valid clinician-administered questionnaire that assess abnormalities due to drug-induced movement disorders both subjectively and objectively.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Mental Health Extrapyramidal Symptom Rating Scale-Abbreviated Clinical Classification Assessment Scale 5628152 CDE Browser
Human Phenotype Ontology Psychosis HP:0000709 HPO
Derived Variables

None

Process and Review

Not applicable.

Source

Chouinard, G., & Margolese, H. C. (2005). Manual for the Extrapyramidal Symptom Rating Scale (ESRS). Schizophrenia Research, 76(2-3), 247-265.

General References

Chouinard, G. (2006). Interrelations between psychiatric symptoms and drug-induced movement disorder. Journal of Psychiatry and Neuroscience, 31(3), 177-180.

Kotler, M., Dilbaz, N., Rosa, F., Paterakis, P., Milanova, V., Smulevich, A. B., Lahaye, M., & Schreiner, A. (2015). A flexible-dose study of paliperidone ER in patients with nonacute schizophrenia previously treated unsuccessfully with oral olanzapine. Journal of Psychiatric Practice, 22(1), 9-21.

Protocol ID:

661601

Variables:
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX661601_Symptoms_Rating_Abnormal_Posture
PX661601060000 Rate the status of the following symptom: more
Oculogyric crisis, abnormal sustained posture show less
N/A
PX661601_Symptoms_Rating_Akathisia_Severity
PX661601450000 Considering your clinical experience, how more
severe is the akathisia at this time? show less
N/A
PX661601_Symptoms_Rating_BuccoLabial_Movement_Constant
PX661601290000 Based on overall observation during more
examination for dyskinetic movement, if the patient has constant bucco-labial movements (puckering, pouting, smacking, etc.), how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_BuccoLabial_Movement_Frequent
PX661601280000 Based on overall observation during more
examination for dyskinetic movement, if the patient has frequent bucco-labial movements (puckering, pouting, smacking, etc.), how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_BuccoLabial_Movement_Occasional
PX661601270000 Based on overall observation during more
examination for dyskinetic movement, if the patient has occasional bucco-labial movements (puckering, pouting, smacking, etc.), how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_Difficulty_Daily_Tasks
PX661601010000 Rate the status of the following symptom: more
Impression of slowness or weakness, difficulty in carrying out routine tasks show less
N/A
PX661601_Symptoms_Rating_Dyskinesia_Severity
PX661601420000 Considering your clinical experience, how more
severe is the dyskinesia at this time? show less
N/A
PX661601_Symptoms_Rating_Dystonia
PX661601190000 Based on overall observation during more
examination for dystonia, how would you rate the patient's degree of acute torsion, and non-acute or chronic or tardive dystonia? show less
N/A
PX661601_Symptoms_Rating_Dystonia_Location
PX661601200000 Where does the patient experience acute more
torsion, and non-acute or chronic or tardive dystonia? show less
N/A
PX661601_Symptoms_Rating_Dystonia_Severity
PX661601440000 Considering your clinical experience, how more
severe is the dystonia at this time? show less
N/A
PX661601_Symptoms_Rating_Involuntary_Movements
PX661601070000 Rate the status of the following symptom: more
Abnormal involuntary movements (dyskinesia) of tongue, jaw, lips, face, extremities or trunk show less
N/A
PX661601_Symptoms_Rating_Involuntary_Movements_Constant
PX661601410000 Based on overall observation during more
examination for dyskinetic movement, if the patient constantly has involuntary movements (swallowing, irregular respiration, frowning, blinking, grimacing, sighing, etc.), how would you rate his/her ability? show less
N/A
PX661601_Symptoms_Rating_Involuntary_Movements_Frequent
PX661601400000 Based on overall observation during more
examination for dyskinetic movement, if the patient frequently has involuntary movements (swallowing, irregular respiration, frowning, blinking, grimacing, sighing, etc.), how would you rate his/her ability? show less
N/A
PX661601_Symptoms_Rating_Involuntary_Movements_Occasional
PX661601390000 Based on overall observation during more
examination for dyskinetic movement, if the patient occasionally has involuntary movements (swallowing, irregular respiration, frowning, blinking, grimacing, sighing, etc.), how would you rate his/her ability? show less
N/A
PX661601_Symptoms_Rating_Jaw_Movement_Constant
PX661601260000 Based on overall observation during more
examination for dyskinetic movement, if the patient has constant jaw movements (lateral movement, chewing, biting, clenching), how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_Jaw_Movement_Frequent
PX661601250000 Based on overall observation during more
examination for dyskinetic movement, if the patient has frequent jaw movements (lateral movement, chewing, biting, clenching), how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_Jaw_Movement_Occasional
PX661601240000 Based on overall observation during more
examination for dyskinetic movement, if the patient has occasional jaw movements (lateral movement, chewing, biting, clenching), how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_Lingual_Movement_Constant
PX661601230000 Based on overall observation during more
examination for dyskinetic movement, if the patient has constant lingual movements (slow lateral or torsion movement of tongue), how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_Lingual_Movement_Frequent
PX661601220000 Based on overall observation during more
examination for dyskinetic movement, if the patient has frequent lingual movements (slow lateral or torsion movement of tongue), how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_Lingual_Movement_Occasional
PX661601210000 Based on overall observation during more
examination for dyskinetic movement, if the patient has occasional lingual movements (slow lateral or torsion movement of tongue), how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_LowerExtremities_Movement_Constant
PX661601380000 Based on overall observation during more
examination for dyskinetic movement, if the patient has constant movement in lower extremities (choreoathetoid movements only: legs, knees, ankles, toes), how would you rate his/her ability? show less
N/A
PX661601_Symptoms_Rating_LowerExtremities_Movement_Frequent
PX661601370000 Based on overall observation during more
examination for dyskinetic movement, if the patient has frequent movement in lower extremities (choreoathetoid movements only: legs, knees, ankles, toes), how would you rate his/her ability? show less
N/A
PX661601_Symptoms_Rating_LowerExtremities_Movement_Occasional
PX661601360000 Based on overall observation during more
examination for dyskinetic movement, if the patient has occasional movement in lower extremities (choreoathetoid movements only: legs, knees, ankles, toes), how would you rate his/her ability? show less
N/A
PX661601_Symptoms_Rating_Nervousness
PX661601040000 Rate the status of the following symptom: more
Restless, nervous, unable to keep still show less
N/A
PX661601_Symptoms_Rating_Parkinsons_Akathisia
PX661601180000 Based on overall observation during more
examination for Parkinsons, how would you rate the patient's degree of Akathisia? show less
N/A
PX661601_Symptoms_Rating_Parkinsons_Automatic_Movements
PX661601170000 Based on overall observation during more
examination for Parkinsons, how would you rate the patient's degree of expressive automatic movements (Facial mask/speech)? show less
N/A
PX661601_Symptoms_Rating_Parkinsons_Bradykinesia
PX661601120000 Based on physical examinations for more
Parkinsons, how would you rate the patient's degree of bradykinesia? show less
N/A
PX661601_Symptoms_Rating_Parkinsons_Gait_Posture
PX661601130000 Based on physical examinations for more
Parkinsons, how would you rate the patient's degree of gait and posture? show less
N/A
PX661601_Symptoms_Rating_Parkinsons_Postural_Stability
PX661601140000 Based on physical examinations for more
Parkinsons, how would you rate the patient's degree of postural stability? show less
N/A
PX661601_Symptoms_Rating_Parkinsons_Rigidity
PX661601150000 Based on physical examinations for more
Parkinsons, how would you rate the patient's degree of rigidity? show less
N/A
PX661601_Symptoms_Rating_Parkinsons_Rigidity_Location
PX661601160000 Where does the patient experience rigidity? N/A
PX661601_Symptoms_Rating_Parkinsons_Severity
PX661601430000 Considering your clinical experience, how more
severe is the parkinsonism at this time? show less
N/A
PX661601_Symptoms_Rating_Stiffness
PX661601030000 Rate the status of the following symptom: more
Stiffness, stiff posture show less
N/A
PX661601_Symptoms_Rating_Tremors
PX661601050000 Rate the status of the following symptom: more
Tremors, shaking show less
N/A
PX661601_Symptoms_Rating_Tremors_Constant
PX661601100000 Based on physical examinations for more
Parkinsons, if the patient has constant or almost constant tremors, how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_Tremors_Frequent
PX661601090000 Based on physical examinations for more
Parkinsons, if the patient has frequent tremors, how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_Tremors_Location
PX661601110000 Where does the patient experience these tremors? N/A
PX661601_Symptoms_Rating_Tremors_Occasional
PX661601080000 Based on physical examinations for more
Parkinsons, if the patient has occasional tremors, how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_Truncal_Movement_Constant
PX661601320000 Based on overall observation during more
examination for dyskinetic movement, if the patient has constant truncal movements (involuntary rocking, twisting, pelvic gyrations), how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_Truncal_Movement_Frequent
PX661601310000 Based on overall observation during more
examination for dyskinetic movement, if the patient has frequent truncal movements (involuntary rocking, twisting, pelvic gyrations), how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_Truncal_Movement_Occasional
PX661601300000 Based on overall observation during more
examination for dyskinetic movement, if the patient has occasional truncal movements (involuntary rocking, twisting, pelvic gyrations, how would you rate the severity? show less
N/A
PX661601_Symptoms_Rating_UpperExtremities_Movement_Constant
PX661601350000 Based on overall observation during more
examination for dyskinetic movement, if the patient has constant movement in upper extremities (choreoathetoid movements only: arms, wrists, hands, fingers), how would you rate his/her ability? show less
N/A
PX661601_Symptoms_Rating_UpperExtremities_Movement_Frequent
PX661601340000 Based on overall observation during more
examination for dyskinetic movement, if the patient has frequent movement in upper extremities (choreoathetoid movements only: arms, wrists, hands, fingers), how would you rate his/her ability? show less
N/A
PX661601_Symptoms_Rating_UpperExtremities_Movement_Occasional
PX661601330000 Based on overall observation during more
examination for dyskinetic movement, if the patient has occasional movement in upper extremities (choreoathetoid movements only: arms, wrists, hands, fingers), how would you rate his/her ability? show less
N/A
PX661601_Symptoms_Rating_Walking
PX661601020000 Rate the status of the following symptom: more
Difficulty walking or with balance show less
N/A
Mental Health Research
Measure Name:

Antipsychotic Medication Extrapyramidal Side Effects

Release Date:

January 17, 2017

Definition

A questionnaire and a patient examination tool to assess drug-induced extrapyramidal symptoms (slowness, stiffness, tremor, and rigidity).

Purpose

This measure is designed to assess the frequency and severity of antipsychotic drug-induced movement disorders (DIMD) including parkinsonism, dyskinesia, akathisia, and dystonia. DMID interferes with cognition and social rehabilitation and is similar to symptoms of psychosis and schizophrenia.

Keywords

Early psychosis, psychosis, extrapyramidal symptom rating scale, ESRS, extrapyramidal features, drug-induced movement disorders, DIMD, drug-induced extrapyramidal symptoms, extrapyramidal side effects, EPSE