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Psychomotor Agitation clinical trials

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NCT ID: NCT02168920 Terminated - Clinical trials for Agitation Associated With Dementia of the Alzheimer's Type

Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Start date: June 11, 2014
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory [CMAI] total score from baseline as the primary efficacy variable), dose-response, and safety of aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation associated with Alzheimer's type dementia

NCT ID: NCT02164773 Recruiting - Agitation Clinical Trials

Addition of Magnesium Sulfate to Caudal to Prevent Postoperative Emergence Agitation.

Start date: October 2013
Phase: Phase 4
Study type: Interventional

Emergence agitation after sevoflurane anesthesia is still a problem needed to be solved.The aim of the study is to delineate the effect of caudal magnesium sulfate in children undergoing lower abdominal surgery to prevent postoperative emergence agitation.

NCT ID: NCT02147652 Enrolling by invitation - Alzheimer's Disease Clinical Trials

Personalized Music Therapy and Agitation in Dementia

Start date: October 14, 2014
Phase: N/A
Study type: Interventional

Symptoms of agitation include abuse or aggressive behaviour toward self or others, appropriate behaviour performed with inappropriate frequency, or behaviours that are inappropriate according to social standards. In the later stages of dementia agitation can contribute significantly to patient distress and caregiver stress, and has been associated with poor quality of life. Previous research studies have shown some evidence that personalized music played in daily care situations reduces agitation. The purpose of this study is to evaluate the effects of personalized music therapy via headphones on agitation during hygiene care (grooming). This study will involve 60 in-patients of the Geriatric Psychiatry ward of Toronto Rehabilitation Institute. The study would take place over the span of 2 weeks and would involve listening to personalized and either non-personalized or no music during daily hygiene care (grooming). Enrolment is completely voluntary and all personal data obtained will remain confidential.

NCT ID: NCT02138357 Withdrawn - Clinical trials for Restless Legs Syndrome

Butrans for Treatment of Restless Legs Syndrome

Butrans
Start date: April 2014
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to determine whether Butrans Transdermal System (BTDS) reduces RLS symptom severity in patients with moderate to severe idiopathic RLS who are naïve to opiate treatment. The secondary objective of the study is to investigate the effects of BTDS on mood, sleep, and quality of life. The study will consist of nine visits. Depending on the need for medication titration, there may also be two scheduled telephone contacts. Visit 1: This is a screening visit to determine study eligibility. Eligible subjects who choose to participate must undergo medication washout as described in the detailed protocol between visits 1 and 2. Treatment period #1 (Visits 2 - 5; day 0 - 28): Baseline measures will be recorded and subjects randomized to treatment order at visit 2 (day 0). Study medication as well as rescue medication (l-dopa, a non-blinded active treatment to be used within a limited dose range as described in the detailed protocol) will be dispensed. Subjects will begin treatment period #1 immediately after this. The study medication will be titrated within the allowed range according to subject's reported symptoms during visit 3 (day 7), visit 4 (day 14), telephone contact (day 21). Visit 5 will occur on day 28 and will include assessment of outcome measures for the first treatment period. Visit 5 will also mark the beginning of the second treatment period. Treatment period #2 (Visits 6 - 8; day 28 - 56): Procedures will be similar to those described above during treatment period #1. Visit 8 will mark the end of the second treatment period during which outcome measures will be ascertained. Follow up visit (Visit 9; day 70): This will be a safety follow-up visit approximately two weeks after visit 8 for review of adverse events.

NCT ID: NCT02129348 Completed - Alzheimer's Disease Clinical Trials

Treatment of Psychosis and Agitation in Alzheimer's Disease

Start date: June 2014
Phase: Phase 2
Study type: Interventional

Clinically, many patients with AD show no response or minimal response to antipsychotics for symptoms of agitation/aggression or psychosis, or they have intolerable side effects on these medications. Antipsychotics have a wide range of side effects, including the risk of increased mortality (60-70% higher rate of death on antipsychotic compared to placebo) that led to an FDA black box warning for patients with dementia; a more recent review and meta-analysis showed a 54% increased risk of mortality. In addition, some patients show only partial response to antipsychotics and symptoms persist. For these reasons, the investigators need to study alternative treatment strategies. Currently, there is no FDA-approved medication for the treatment of psychosis or agitation in AD. The investigators innovative project will examine the efficacy and side effects of low dose lithium treatment of agitation/aggression with or without psychosis in 80 patients with AD in a randomized, doubleblind, placebo-controlled, 12-week trial (essentially a Phase II trial). The results will determine the potential for a large-scale clinical trial (Phase III) to establish the utility of lithium in these patients.

NCT ID: NCT02117076 Terminated - Clinical trials for Restless Leg Syndrome

Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizantâ„¢) in Restless Leg Syndrome

Start date: April 2014
Phase: Phase 4
Study type: Interventional

The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.

NCT ID: NCT02104297 Not yet recruiting - Agitation Clinical Trials

Effect of Deksmedetomidine and Remifentanil in Extubation Agitation

EA
Start date: April 2014
Phase: Phase 4
Study type: Interventional

To compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation.

NCT ID: NCT02103881 Withdrawn - Agitation Clinical Trials

Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

Start date: April 2014
Phase: Phase 4
Study type: Interventional

This research study is being done to find out if one of two drugs, ketamine or haloperidol, is better for treating agitation. Agitation is a state of extreme emotional disturbance where patients can become physically aggressive or violent, endangering themselves and those who are caring for them. Often chemical substances or severe mental illness is involved in this level of agitation. Specifically, the investigators are interested in studying agitation that is treated in the prehospital setting by paramedics. This study's hypothesis is that ketamine is superior to haloperidol for treatment of agitation in the prehospital environment.

NCT ID: NCT02027844 Completed - Clinical trials for Psychomotor Agitation

Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia

Start date: December 2013
Phase: N/A
Study type: Interventional

Nearly 50% of young children undergoing surgery exhibit high level of anxiety during induction of anesthesia because of exposure to unfamiliar environment and people and separation from parents. Increased preoperative anxiety may impact postoperative behavior changes such as emergence agitation, separation anxiety and sleep disturbance. Although some pediatric anesthesiologists routinely permit parental presence to reduce the anxiety during induction of anesthesia, previous studies have reported conflicting results. Recently the distraction using video game or animated cartoon has been reported to reduce anxiety of young children during induction of anesthesia. However, it was still undetermined whether distraction has its own ability to reduce children's anxiety separated from parental presence because they evaluated the effect of video method in the parental presence. The investigators design to investigated the efficacy of distraction with watching cartoon, parental presence and combined with watching cartoon and parental presence on reduction of anxiety during inhalational induction of anesthesia using sevoflurane. In addition this study includes long-term effect of each intervention such as postoperative emergence agitation and postoperative behavior change in children.

NCT ID: NCT02025608 Completed - Clinical trials for Restless Legs Syndrome

Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome

AUTOREST
Start date: December 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to explore whether patients with restless legs syndrome (RLS) differ from healthy subjects in daytime and night time autonomic function and cardiovascular risk markers and whether 4 week treatment with pramipexole affects autonomic function and cardiovascular risk markers in patients with RLS.