Participants randomised to the placebo group will receive one 15-minute IV infusion of Saline at 4 visits.

Participants randomised to the treatment group will receive one 15-minute IV infusion of Scopolamine at 4 visits.

Bipolar Disorder Depression

The treatment group will receive a 100ml infusion of Scopolamine ( dose 4μg/kg) at 4 visits during the study

Scopolamine

The placebo group will receive a 100ml infusion of saline at 4 visits during the study

Placebo

Scopolamine in Bipolar Depression

A Randomised Double-Blinded Placebo-Controlled Trial to Assess the Efficacy and Safety of Scopolamine Compared to Placebo in Individuals With Bipolar Disorder Who Are Experiencing a Depressive Episode

The primary outcome measure will be the change from Visit 3 (randomisation visit) in severity of objective depressive symptoms after the final scheduled treatment as measured by change in the Hamilton Depression Rating Scale score (range 0-53) from Visit 3 (pre-infusion and randomisation) to Visit 6, with reduced scores indicating an improvement in depressive symptoms and better outcome.

Remission of depressive episode after the last IV treatment (measured objectively at Visit 6), and is defined as occurring when an individual has:
a Hamilton Depression Rating Scale score ≤7 (note range of scores are from 0-53 with lower scores indicating less symptoms of depression and better outcome).

Remission of depressive episode after the last IV treatment (measured objectively at Visit 6), and is defined as occurring when an individual has:
a Montgomery and Asberg Depression Rating Scale score <6 (note range of scores are from 0-60 with lower scores indicating less symptoms of depression and better outcome).

Remission of depressive episode at follow-up (measured objectively at Visit 7) a Hamilton Depression Rating Scale score ≤7 (note range of scores are 0-53 with lower scores indicating less symptoms of depression and better outcome).

Remission of depressive episode at follow-up (measured objectively at Visit 7) a Montgomery and Asberg Rating Scale score <6 (Note range of scores are from 0-60 with lower scores indicating less symptoms of depression and better outcome).

Improvement in objectively measured overall functioning, measured with the Global Assessment of Functioning Scale at Visit 6 (note range of scores are from 0-100, with higher scores indicating better overall functioning and better outcome)

Improvement in objectively measured overall functioning, measured with the Global Assessment of Functioning Scale at Visit 7 (note range of scores are 0-100, with higher scores indicating better overall functioning and better outcome).

Improvement in objectively rated illness severity, measured with the Clinical Global Impression Scale - Improvement at Visit 6 (note range of scores are 1-7, with lower scores (1-3) indicating improved outcome and higher scores (5-7) indicating a worse outcome. A score of 4 indicates no change in symptoms).

Improvement in objectively rated illness severity, measured with the Clincial Global Impression Improvement Scale at Visit 7 (note range of scores are from 1-7 with lower scores indicating improved outcome).

Change in subjective measured depressive symptoms with the Profile of Mood Scores. A reduction in the Profile of Mood Score for depression post-infusion compared to pre-infusion at visits 2 indicates less depressive symptoms and improved outcome (note range of scores are 0-4 with lower scores indicating less depressive symptoms).

Change in subjective measured mood disturbance symptoms with the Profile of Mood Scores. A reduction in the Profile of Mood Score for total mood disturbance post-infusion compared to pre-infusion at visits 2 indicates less disturbance of mood symptoms and improved outcome (note range of scores are 0-20) with lower scores indicating lower levels of mood disturbance and improved outcome.

Change in subjective measured depressive symptoms with the Profile of Mood Score for depression at follow-up visit 6 (note range of scores are 0-4 with lower scores indicating less depressive symptoms and improved outcome).

Change in subjective measured depressive symptoms with the Profile of Mood Scores for Depression at follow-up visit 7 (note range of scores are 0-4 with lower scores indicating less depressive symptoms and improved outcome).

Change in subjective measured mood disturbance symptoms with the Profile of Mood Scores for Depression at follow-up visit 6 (note range of scores are 0-20 with lower scores indicating lower levels of mood disturbance and improved outcome).

Change in subjective measured mood disturbance symptoms with the Profile of Mood Scores for Depression at follow-up visit 7 (note range of scores are 0-20 with lower scores indicating lower levels of mood disturbance and improved outcome).

Change in subjective measured feelings of anger with the Profile of Mood Scores - Anger at follow-up Visit 6 (note range of scores are 0-4 with lower scores indicating less anger and improved outcome).

Change in subjective measured feelings of anger with the Profile of Mood Scores - Anger at follow-up Visit 7 (note range of scores are 0-4 with lower scores indicating less anger and improved outcome).

Change in subjective measured feelings of anger with the Profile of Mood Scores - Anger. A reduction in Profile of Mood Score for Anger score post-infusion compared to pre-infusion at visits 2 indicating less anger and improved outcome with range of scores of 0-4).

Change in subjective measured symptoms of tension with the POMS - Tension. A reduction in Profile of Mood Scores for tension score post-infusion compared to pre-infusion at visits 2 indicates lower levels of tension and improved outcome with scores ranging from 0-4.
3, 4 and 5.

Change in subjective measured symptoms of tension using the Profile of Mood Scores - Tension at follow-up Visit 6. A reduction in Profile of Mood Scores for tension score post-infusion compared to pre-infusion at visits 2 indicates lower levels of tension and improved outcome with scores ranging from 0-4.

Change in subjective measured symptoms of tension using the Profile of Mood Scores - Tension at follow-up Visit 7. A reduction in Profile of Mood Scores for tension score post-infusion compared to pre-infusion at visits 2 indicates lower levels of tension and improved outcome with scores ranging from 0-4.

Change subjective measured symptoms of fatigue with the Profile of Mood Scores - Fatigue. A reduction in Profile of Mood Scores for fatigue score post-infusion compared to pre-infusion at visits 2 indicates lower levels of fatigue and improved outcome with scores ranging from 0-4.
3, 4 and 5.

Change in subjective measured symptoms of fatigue using the Profile of Mood Scores - Fatigue at follow-up Visit 6. A reduction in Profile of Mood Scores for fatigue score post-infusion compared to pre-infusion at visits 2 indicates lower levels of fatigue and improved outcome with scores ranging from 0-4.

Change in subjective measured symptoms of fatigue at follow-up Visit 7. A reduction in Profile of Mood Scores for fatigue score post-infusion compared to pre-infusion at visits 2 indicates lower levels of fatigue and improved outcome with scores ranging from 0-4.

Changing subjective measured symptoms of vigour with the Profile of Mood Scores. An increase in vigour measured with the Profile of Mood Scores - Vigour score post-infusion compared to pre-infusion at visits 2 indicates higher levels of vigour andimproved outcome, with scores ranging from 0-4.

Change in subjective measured symptoms of vigour at follow-up Visit 6 measured with the Profile of Mood Scores - Vigour. An increase in vigour measured with the Profile of Mood Scores - Vigour score post-infusion compared to pre-infusion at visits 2 indicates higher levels of vigour improved outcome, with scores ranging from 0-4.

Change in subjective measured symptoms of vigour at follow-up Visit 7. An increase in vigour measured with the Profile of Mood Scores - Vigour score post-infusion compared to pre-infusion at visits 2 indicates higher levels of vigour and improved outcome, with scores ranging from 0-4.

Change in subjective measured symptoms of confusion with the Profile of Mood Scores - Confusion. A reduction in Profile of Mood Scores - Confusion score post-infusion compared to pre-infusion at visits 2 indicates lower levels of confusion and improved outcome, with scores ranging from 0-4.
3, 4 and 5.

Change in subjective measured symptoms of confusion at follow-up Visit 6 measured with the Profile of Mood Scores - Confusion. A reduction in Profile of Mood Scores - Confusion score post-infusion compared to pre-infusion at visits 2 indicates lower levels of confusion and improved outcome, with scores ranging from 0-4.

Change in subjective measured symptoms of confusion at follow-up Visit 7 measured with the Profile of Mood Scores - Confusion. A reduction in Profile of Mood Scores - Confusion score post-infusion compared to pre-infusion at visits 2 indicates lower levels of confusion and improved outcome, with scores ranging from 0-4.

A change in subjectively measured levels of happiness as measured with the Visual Analogue Scale for happiness. Higher scores indicate increased happiness and improved outcome, with scores ranging from 0-10.

A change in subjectively measured levels of restlessness as measured with the Visual Analogue Scale for Restlessness. Lower scores indicate reduced restlessness and improved outcome, with scores ranging from 0-10.

A change in subjectively measured levels of sadness as measured with the Visual Analogue Scale for sadness. Lower scores indicate reduced sadness and improved outcome, with scores ranging from 0-10.

A change in subjectively measured levels of anxiety as measured with the Visual Analogue Scale for Anxiety. Lower scores indicate reduced anxiety and improved outcome, with scores ranging from 0-10.

A change in subjectively measured levels of anger as measured with the Visual Analogue Scale for Anger. Lower scores indicate reduced anger and improved outcome, with scores ranging from 0-10.

A change in subjectively measured levels of drowsiness as measured with the Visual Analogue Scale. Lower scores indicate reduced drowsiness and improved outcome, with scores ranging from 0-10.

A change in subjectively measured levels of alertness as measured with the Visual Analogue Scale for alertness. Higher scores indicate increased alertness and improved outcome, with scores ranging from 0-10.

Psychiatric inpatient admission of a participant due to depressive episodes during the trial (Visits 2 to 7)

Antidepressants medication use or change by a participant due to depressive episodes over the duration of the study (Visit 2 to Visit 7):
(i) Introduction of a new antidepressant (yes / no) (ii) Increase in dose of an existing antidepressant (yes / no)

Change in executive functioning using the Cambridge Neuropsychological Test Automated Battery (CANTAB)

Change in visual processing the Cambridge Neuropsychological Test Automated Battery (CANTAB)

Change in motor processing utilising the CANTAB

Change in emotion recognition utilising the CANTAB

Occurrence of a hypo (manic) episodes by the YMRS during study

Occurrence of bradycardia - measured at each visit post-infusion

Occurrence of hypotension - measured at each visit post-infusion

Occurrence of adverse effects reported by patient at visits 2,3,4,5,6,7

Occurrence of adverse effects as reported by participants or measured utilising the PRISE questionnaire

Dr. Brian Hallahan

Senior Lecturer and Consultant Psychiatrist, Department of Psychiatry

Stanley Medical Research Institute

National University of Ireland, Galway, Ireland

HRB Clinical Research Facility Galway, Ireland

University College Hospital Galway

Will receive a 20 ml mixture of 10 ml of Liposomal Bupivacaine 1.3% and 10 ml of Bupivacaine HCl 0.5%.

Will receive 20 ml of Bupivacaine HCl 0.5% with 4 mg of preservative-free dexamethasone.

Rotator Cuff Tears

20 ml mixture of 10 ml of Liposomal Bupivacaine 1.3% and 10 ml of Bupivacaine HCl 0.5%.

Liposomal bupivacaine

20 ml of Bupivacaine HCl 0.5% with 4 mg of preservative-free dexamethasone.

Bupivacaine with Dexamethasone Solution

Penn Presbyterian Medical Center

Liposomal Bupivacaine in Shoulder Arthroscopy

The Effect of Liposomal Bupivacaine on the Quality of Recovery in Patients Undergoing Shoulder Arthroscopy

The primary outcome will be defined as the Quality of Recovery (QoR-15) score at 48 hours after surgery. There are 15 questions assessed on a scale of 0-10, 10 being the better outcome.

Patient reported pain scores on a scale of 0(no pain)-10(extreme pain),

Patient reported opioid use for 72 hours.

Measurement of opioid given to patient at PACU in morphine equivalents.

Nabil Elkassabany

Physician

University of Pennsylvania

Randomization between Group 1 and Group 2

The research assistant collecting the data as well the patient will be blinded to the nature of the group assignments.

Scopolamine (0.3 mg/1 ml, i.m.) Bid; escitalopram （10 mg/d p.o.）QD

Scopolamine (0.3 mg/1 ml, i.m.) QD; placebo (1 ml saline, i.m.) QD; escitalopram （10 mg/d p.o.）QD

Placebo (1 ml saline, i.m.) Bid; escitalopram （10 mg/d p.o.）QD

Major Depressive Disorder

Intramuscular injection with scopolamine (0.3 mg/1ml,QD or Bid) during the first three days;

Oral escitalopram 10 mg/d throughout the total of 4 weeks treatment

Escitalopram

Intramuscular injection with saline (1ml, QD or Bid) during the first three days;

Saline

Beijing Anding Hospital

Effectiveness Study of Scopolamine Combined With Escitalopram in Patients With MDD

A Double-blind, Controlled, Randomized Study Comparing Escitalopram Combined With Scopolamine or Escitalopram in Patients With Major Depressive Disorder

The time from randomization (baseline) to early improvement (at least 20% reduction in HAMD-17 score )

The proportion of subjects with at least 50% decrease in the HAMD-17 at any visit from baseline.Response was defined as ≥50% decrease in the baseline HAMD-17 total scores.

Remission was defined as the HAMD total score ≤7

Change in HAMD-17 scores measured by the difference between baseline HAMD-17 score and HAMD-17 score at endpoint.

Change in MADRS scores measured by the difference between baseline MADRS score and MADRS score at endpoint.

Change in QIDS-SR16 score measured by the difference between baseline QIDS-SR16 score and QIDS-SR16 score at endpoint.

Change in GAD7 score measured by the difference between baseline GAD7 score and GAD7 score at endpoint.

Change in YMRS score measured by the difference between baseline YMRS score and YMRS score at endpoint.

Change in CGI-S score measured by the difference between baseline CGI-S score and CGI-S score at endpoint.

The incidence and nature of overall adverse events; the incidence and nature of drug-related adverse events; assessment of cognitive function change by PDQ-D5

Gang Wang, MD

Director of Beijing Anding Hospital

Capital Medical University

GROUP 1: The patients received intramuscular injection treatment of scopolamine (0.3 mg/ml) at 9 am and 0.9% saline treatment at 3pm. GROUP 2: The patients received intramuscular injection treatment of scopolamine (0.3 mg/ml) at 9 am and 3 PM. GROUP 3: The patients received intramuscular injection treatment of 0.9% saline (1 ml) at 9 am and 3 PM.

Participants will be randomized to either .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via nasal drops, prior to each session of exposure therapy

Participants will be randomized to a placebo, administered via nasal drops, prior to each session of exposure therapy

Social Anxiety Disorder

Participants will be randomized to either, .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via nasal drops, prior to each session of exposure therapy

Participants will be randomized to a drug placebo, administered via nasal drops, prior to each session of exposure therapy

intranasal placebo

University of California, Los Angeles

Generalization of Extinction Learning

Cholinergic Decontextualization of Exposure Therapy for Anxiety

Michelle Craske

Professor, Department of Psychology

Scopolamine 1.5 milligram(mg) patch Propofol infusion remifentanil infusion 250mg erythromycin po for 2 doses Solumedrol 0.625mg IV droperidol 4mg IV Ondansetron Ketorolac 30mg IV ibuprofen 600mg po q6h Fentanyl Hydrocodone/Tylenol po

This arm was managed perioperatively with the protocol.

Intervention Cohort

This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.

Comparison Cohort

Total

Sex: Female, Male

End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted.

Patients undergoing maxillary surgery using the antiemetic anesthetic protocol

Post-operative Nausea

Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge.

Hospital Length of Stay

To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital

Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary.

This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary

Post-discharge Nausea

Post-operative Vomiting

Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary

Post-discharge Vomiting

Patients undergoing maxillary surgery using antiemetic anesthesia protocol

Overall Study

Dr. Jay Anderson, PI

Patients undergoing maxillary surgery using the antiemetic anesthesia protocol

Nausea Persistent

Intervention group consisted of patients undergoing maxillary osteotomy who received an antiemetic protocol designed to provide multimodal antiemetic therapy which have been shown to help prevent and/or treat postoperative nausea, combined with the elimination of anesthetic factors that may contribute to postoperative nausea and vomiting.

Antiemetic anesthesia protocol

UNC-Chapel Hill

Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery

A Prospective Evaluation of an Anesthesia Protocol to Reduce Post-operative and Post-discharge Nausea and Vomiting in a High Risk Orthognathic Surgery Population

anxiety/scopolamine

Scopolamine in Bipolar Depression

Liposomal Bupivacaine in Shoulder Arthroscopy

Effectiveness Study of Scopolamine Combined With Escitalopram in Patients With MDD

Generalization of Extinction Learning

Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery

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