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dextroamphetamine and Chronic Insomnia

dextroamphetamine has been researched along with Chronic Insomnia in 24 studies

Dextroamphetamine: The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.
(S)-amphetamine : A 1-phenylpropan-2-amine that has S configuration.

Research Excerpts

ExcerptRelevanceReference
"Cataplexy was not affected by amphetamine treatment, but was abolished in two patients when clomipramine was given together with either amphetamine."6.64Levo(-) amphetamine and dextro(+) amphetamine in the treatment of narcolepsy. ( Fenton, GW; Parkes, JD, 1973)
" Most adverse events were mild to moderate and occurred during the first 4 weeks."2.73Long-term effectiveness and safety of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. ( Childress, AC; Findling, RL; Krishnan, S; McGough, JJ, 2008)
"To compare the side effect profiles of methylphenidate (MPH) and dexamphetamine (DEX) in children with attention deficit hyperactivity disorder (ADHD), as well as to determine which symptoms are genuine adverse effects of stimulant medication, as opposed to aspects of the child's underlying behavioral phenotype."2.68Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial. ( Barker, M; Efron, D; Jarman, F, 1997)
"Cataplexy was not affected by amphetamine treatment, but was abolished in two patients when clomipramine was given together with either amphetamine."2.64Levo(-) amphetamine and dextro(+) amphetamine in the treatment of narcolepsy. ( Fenton, GW; Parkes, JD, 1973)
" The unique pharmacokinetic profile owing to lisdexamfetamine's prodrug design and rate-limited enzymatic biotransformation allows for once-daily dosing with a duration of activity of approximately 12 hours."2.45Lisdexamfetamine for treatment of attention-deficit/hyperactivity disorder. ( Cowles, BJ, 2009)
" However, later timing of stimulant dosing was correlated with later sleep times, p < ."1.39Adults with ADHD-without insomnia history have subclinical sleep disturbance but not circadian delay: an ADHD phenotype? ( Fargason, RE; Gamble, KL; Hollar, AF; White, S, 2013)

Research

Studies (24)

TimeframeStudies, this research(%)All Research%
pre-199015 (62.50)18.7374
1990's4 (16.67)18.2507
2000's3 (12.50)29.6817
2010's2 (8.33)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Findling, RL1
Childress, AC1
Krishnan, S1
McGough, JJ1
Cowles, BJ1
Rostain, AL1
Surman, CB1
Roth, T1
Fargason, RE1
Hollar, AF1
White, S1
Gamble, KL1
KORNETSKY, C1
MIRSKY, AF1
KESSLER, EK1
DORFF, JE1
Golinko, BE2
Rubinstein, S1
Silver, LB1
Licamele, WL1
Bhatara, VS1
Kallepalli, BR1
Misra, LK1
Awadallah, S1
Efron, D1
Jarman, F1
Barker, M1
Lilley, LL1
Guanci, R1
Oswald, I1
Livingston, S1
Pauli, LL1
Stunkard, A1
Rickels, K1
Hesbacher, P1
Parkes, JD1
Fenton, GW1
Conners, CK2
Eisenberg, L1
Taylor, E1
Meo, G1
Kurtz, MA1
Fournier, M1
Greenberg, LM1
Deem, MA1
McMahon, S1
Arnold, LE1
Wender, PH1
McCloskey, K1
Snyder, SH1
Weiss, G1
Werry, J1
Minde, K1
Douglas, V1
Sykes, D1
Yoss, RE1
Daly, DD1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase III, Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).[NCT00152022]Phase 3412 participants Interventional2005-04-25Completed
A Phase III, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group, Forced Dose Titration, Safety and Efficacy Study of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)[NCT00334880]Phase 3420 participants (Actual)Interventional2006-05-31Completed
A Multi-Center, Open Label, Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder[NCT03337646]Phase 448 participants (Actual)Interventional2018-09-26Active, not recruiting
Pharmacological Treatment of Rett Syndrome by Stimulation of Synaptic Maturation With Recombinant Human IGF-1(Mecasermin [rDNA] Injection)[NCT01777542]Phase 230 participants (Actual)Interventional2013-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Aberrant Behavior Checklist - Community Edition (ABC-C)

"The ABC-C is a global behavior checklist implemented for the measurement of drug and other treatment effects in populations with intellectual disability. Behavior based on 58 items that describe various behavioral problems.~Each item is rated on the parents perceived severity of the behavior. The answer options for each item are:~0 = Not a problem~= Problem but slight in degree~= Moderately serious problem~= Severe in degree~The measure is broken down into the following subscales with individual ranges as follows:~Subscale I (Irritability): 15 items, score range = 0-45 Subscale II (Lethargy): 16 items, score range = 0-48 Subscale III (Stereotypy): 7 items, score range = 0-21 Subscale IV (Hyperactivity): 16 items, score range = 0-48 Subscale V (Inappropriate Speech) was not included in the breakdown because it was not applicable (no participants in the study had verbal language)." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First Intervention: Subscale IVisit 3 - First Intervention: Subscale IVisit 5 - First Intervention: Subscale IVisit 6 - Second Intervention: Subscale IVisit 8 - Second Intervention: Subscale IVisit 10 - Second Intervention: Subscale IFollow-up: Subscale I (Irritability)Visit 1 - First Intervention: Subscale IIVisit 3 - First Intervention: Subscale IIVisit 5 - First Intervention: Subscale IIVisit 6 - Second Intervention: Subscale IIVisit 8 - Second Intervention: Subscale IIVisit 10 - Second Intervention: Subscale IIFollow-up: Subscale II (Lethargy)Visit 1 - First Intervention: Subscale IIIVisit 3 - First Intervention: Subscale IIIVisit 5 - First Intervention: Subscale IIIVisit 6 - Second Intervention: Subscale IIIVisit 8 - Second Intervention: Subscale IIIVisit 10 - Second Intervention: Subscale IIIFollow-up: Subscale III (Stereotypy)Visit 1 - First Intervention: Subscale IVVisit 3 - First Intervention: Subscale IVVisit 5 - First Intervention: Subscale IVVisit 6 - Second Intervention: Subscale IVVisit 8 - Second Intervention: Subscale IVVisit 10 - Second Intervention: Subscale IVFollow-up: Subscale IV (Hyperactivity)
Placebo First, Then rhIGF-19.009.007.007.004.005.003.0013.0011.009.0011.008.006.006.0013.0010.0011.0011.0010.008.008.0013.0012.0011.0011.007.0010.009.00
rhIGF-1 First, Then Placebo6.004.002.004.003.005.002.008.007.006.005.005.004.005.0012.0010.009.0011.009.009.009.008.008.006.007.004.005.005.00

Anxiety, Depression, and Mood Scale (ADAMS)

"Remaining subscales of the ADAMS that are not primary outcome measures include: Manic/hyperactive, Depressed mood, General anxiety, Obsessive/compulsive behavior.~The range for each subscale is as follows:~Manic/Hyperactive Behavior: 0-15 Depressed Mood: 0-21 General Anxiety: 0-21 Obsessive/Compulsive Behavior: 0-9~The higher the score for each subscale, the more problematic the behavior." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1- First Intervention: Manic/HyperactiveVisit 2- First Intervention: Manic/HyperactiveVisit 3- First Intervention: Manic/HyperactiveVisit 4- First Intervention: Manic/HyperactiveVisit 5- First Intervention: Manic/HyperactiveVisit 6- Second Intervention: Manic/HyperactiveVisit 7- Second Intervention: Manic/HyperactiveVisit 8- Second Intervention: Manic/HyperactiveVisit 9- Second Intervention: Manic/HyperactiveVisit 10- First Intervention: Manic/HyperactiveFollow-up: Manic/Hyperactive SubscaleVisit 1- First Intervention: Depressed MoodVisit 2- First Intervention: Depressed MoodVisit 3- First Intervention: Depressed MoodVisit 4- First Intervention: Depressed MoodVisit 5- First Intervention: Depressed MoodVisit 6- Second Intervention: Depressed MoodVisit 7- Second Intervention: Depressed MoodVisit 8- Second Intervention: Depressed MoodVisit 9- Second Intervention: Depressed MoodVisit 10- Second Intervention: Depressed MoodFollow-up: Depressed Mood SubscaleVisit 1- First Intervention: General AnxietyVisit 2- First Intervention: General AnxietyVisit 3- First Intervention: General AnxietyVisit 4- First Intervention: General AnxietyVisit 5- First Intervention: General AnxietyVisit 6- Second Intervention: General AnxietyVisit 7- Second Intervention: General AnxietyVisit 8- Second Intervention: General AnxietyVisit 9- Second Intervention: General AnxietyVisit 10- Second Intervention: General AnxietyFollow-up: General Anxiety SubscaleVisit 1- First Intervention: Obsessive CompulsiveVisit 2- First Intervention: Obsessive CompulsiveVisit 3- First Intervention: Obsessive CompulsiveVisit 4- First Intervention: Obsessive CompulsiveVisit 5- First Intervention: Obsessive CompulsiveVisit 6- Second Intervention: Obsessive CompulsiveVisit 7- Second Intervention: Obsessive CompulsiveVisit 8- Second Intervention: Obsessive CompulsiveVisit 9- Second Intervention: Obsessive CompulsiveVisit 10- First Intervention: Obsessive CompulsiveFollow-up: Obsessive Compulsive Behavior Subscale
Placebo First, Then rhIGF-18.007.007.007.007.008.006.506.006.005.005.002.004.003.002.002.002.003.002.003.002.002.008.006.006.005.005.006.006.006.004.004.005.504.004.004.003.003.003.003.003.003.002.003.50
rhIGF-1 First, Then Placebo7.007.006.005.004.006.005.005.004.004.505.004.005.003.003.004.004.003.003.002.003.003.506.007.006.005.005.007.005.004.003.004.004.003.004.004.003.003.003.003.003.002.002.503.00

Anxiety, Depression, and Mood Scale (ADAMS) - Social Avoidance Subscale

"The ADAMS is completed by the parent/caregiver/LAR and consists of 29 items which are scored on a 4-point rating scale that combines frequency and severity ratings. The instructions ask the rater to describe the individual's behavior over the last six months on the following scale: 0 if the behavior has not occurred, 1 if the behavior occurs occasionally or is a mild problem, 2 if the behavior occurs quite often or is moderate problem, or 3 if the behavior occurs a lot or is a severe problem.~The Social Avoidance subscale of the ADAMS will be used as a primary outcome measure for this trial. The range for this subscale is 0-21. The higher the subscale score, the more problematic the behavior." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-16.005.005.006.005.004.004.004.003.003.504.00
rhIGF-1 First, Then Placebo4.005.004.004.003.004.004.004.003.003.503.00

Clinical Global Impression - Improvement (CGI-I)

"Each time the patient was seen after the study intervention was initiated, the clinician compared the patient's overall clinical condition to the CGI-S score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

,
Interventionunits on a scale (Median)
Visit 3 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 8 - Second InterventionVisit 10 - Second Intervention
Placebo First, Then rhIGF-14.004.004.004.004.00
rhIGF-1 First, Then Placebo4.004.004.004.004.00

Clinical Global Impression - Severity (CGI-S)

"This scale is used to judge the severity of the subject's disease prior to entry into the study. The clinician will rate the severity of behavioral symptoms at baseline on a 7-point scale from not impaired to the most impaired.~The scores that correspond to each possible grouping are as follows: 1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 3 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 8 - Second InterventionVisit 10 - Second Intervention
Placebo First, Then rhIGF-14.004.004.004.004.004.00
rhIGF-1 First, Then Placebo4.004.004.004.004.004.50

Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)

"The CSBS-DP was designed to measure early communication and symbolic skills in infants and young children (that is, functional communication skills of 6 month to 2 year olds). The CSBS-DP measures skills from three composites: (a) Social (emotion, eye gaze, and communication); (b) Speech (sounds and words); and (c) Symbolic (understanding and object use) and asks about developmental milestones. The data reported are the composite scores for these three categories.~The possible scores for the three composite categories are as follows:~Social Composite = 0-48; Speech Composite = 0-40; Symbolic Composite = 0-51.~A higher score indicates more advanced abilities in that area." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First Intervention: SocialVisit 2: Social Composite ScoreVisit 3: Social Composite ScoreVisit 4: Social Composite ScoreVisit 5: Social Composite ScoreVisit 6 - Second Intervention: SocialVisit 7 - Second Intervention: SocialVisit 8 - Second Intervention: SocialVisit 9 - Second Intervention: SocialVisit 10 - Second Intervention: SocialFollow-up: Social Composite ScoreVisit 1 - First Intervention: SpeechVisit 2 - First Intervention: SpeechVisit 3 - First Intervention: SpeechVisit 4 - First Intervention: SpeechVisit 5 - First Intervention: SpeechVisit 6 - Second Intervention: SpeechVisit 7 - Second Intervention: SpeechVisit 8 - Second Intervention: SpeechVisit 9 - Second Intervention: SpeechVisit 10 - Second Intervention: SpeechFollow-up: Speech Composite ScoreVisit 1 - First Intervention: SymbolicVisit 2 - First Intervention: SymbolicVisit 3 - First Intervention: SymbolicVisit 4 - First Intervention: SymbolicVisit 5 - First Intervention: SymbolicVisit 6 - Second Intervention: SymbolicVisit 7 - Second Intervention: SymbolicVisit 8 - Second Intervention: SymbolicVisit 9 - Second Intervention: SymbolicVisit 10 - Second Intervention: SymbolicFollow-up: Symbolic Composite Score
Placebo First, Then rhIGF-119.0020.0018.0018.0020.0018.0020.0021.0021.0022.5022.504.003.005.005.506.504.004.005.005.005.006.009.5010.5010.5012.0011.5013.0010.2511.5011.5013.7514.25
rhIGF-1 First, Then Placebo22.0024.0024.0024.0023.0028.0025.0027.0029.0027.0028.007.005.008.005.008.008.507.006.505.007.256.0014.0014.5015.0014.0016.5018.5017.0017.0018.0017.0018.00

Kerr Clinical Severity Scale

"The Kerr clinical severity scale (Kerr scale) is a quantitative measure of global disease severity. The Kerr scale is a summation of individual items related to Rett syndrome phenotypic characteristics. The items are based on the severity or degree of abnormality of each characteristic on a discrete scale (0, 1, 2) with the highest level corresponding to the most severe or most abnormal presentations.~The possible range of scores is 0-48. The higher the score, the more severe the symptoms." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 10 - Second Intervention
Placebo First, Then rhIGF-116.5015.0015.0014.00
rhIGF-1 First, Then Placebo18.0018.0019.0020.00

Mullen Scales of Early Learning (MSEL)

"The MSEL is a standardized developmental test for children ages 3 to 68 months consisting of five subscales: gross motor, fine motor, visual reception, expressive language, and receptive language.~The raw score is reported for each subscale domain. The potential score ranges are as follows:~Visual Reception: 33 items, score range=0-50, Fine Motor: 30 items, score range= 0-49, Receptive Language: 33 items, score range= 0-48, Expressive Language: 28 items, score range= 0-50. The gross motor subscale was not included in this population.~A higher raw score indicates more advanced abilities in that section." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

,
Interventionunits on a scale (Median)
Visit 1- First Intervention: Visual ReceptionVisit 5- First Intervention: Visual ReceptionVisit 6- Second Intervention: Visual ReceptionVisit 10: Visual Reception Raw ScoreVisit 1- First Intervention: Fine MotorVisit 5- First Intervention: Fine MotorVisit 6- Second Intervention: Fine MotorVisit 10- Second Intervention: Fine MotorVisit 1- First Intervention: Receptive LanguageVisit 5- First Intervention: Receptive LanguageVisit 6- Second Intervention: Receptive LanguageVisit 10- Second Intervention: Receptive LanguageVisit 1- First Intervention: Expressive LanguageVisit 5- First Intervention: Expressive LanguageVisit 6- Second Intervention: Expressive LanguageVisit 10- Second Intervention: Expressive Language
Placebo First, Then rhIGF-117.0026.0023.0028.0010.009.0011.009.0020.0030.0031.0031.008.009.006.008.00
rhIGF-1 First, Then Placebo26.0039.5042.0044.007.007.0010.008.5025.5032.0038.0036.509.008.0010.008.00

Parent Targeted Visual Analog Scale (PTSVAS) - Scale 1

"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-16.504.705.655.054.804.954.555.654.154.805.60
rhIGF-1 First, Then Placebo8.804.805.355.105.155.204.655.005.155.055.08

Parent Targeted Visual Analog Scale (PTSVAS) - Scale 2

"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-17.754.505.855.005.005.355.505.153.804.905.15
rhIGF-1 First, Then Placebo6.355.255.955.405.457.105.855.005.134.955.20

Parent Targeted Visual Analog Scale (PTSVAS) - Scale 3

"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-17.854.705.654.155.006.204.804.854.604.134.55
rhIGF-1 First, Then Placebo5.705.005.205.355.105.354.955.155.254.555.10

Parental Global Impression - Improvement (PGI-I)

"As part of each visit after the study intervention was initiated, the parent/caregiver was asked to compare the patient's overall clinical condition to the score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-14.003.003.003.004.003.003.003.003.003.00
rhIGF-1 First, Then Placebo4.004.004.003.003.003.003.003.003.003.00

Parental Global Impression - Severity (PGI-S)

"The PGI-S is the parent version of the CGI-S. Parents/caregivers/LAR are asked to rate the severity of their child's symptoms at baseline on a 7-point scale from not at all impaired to the most impaired. The parents/caregivers/LAR will complete the PGI-S at each study visit.~The scores that correspond to each possible grouping are as follows:~1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-14.004.004.004.004.004.004.004.004.004.004.00
rhIGF-1 First, Then Placebo6.004.004.004.004.004.004.006.006.005.004.00

Quantitative Measures of Respiration: Apnea Index

"Respiratory data was collected using non-invasive respiratory inductance plethysmography from a BioCapture® recording device. BioCapture® is a child-friendly measurement device that can record from 1 to 12 physiological signal transducers in a time-locked manner. It can be configured with the pediatric chest and abdominal plethysmography bands and the 3 lead ECG signals we plan to use for monitoring cardiac safety throughout the study. Each transducer is placed on the patient independently to provide a customized fit that yields the highest signal quality for each patient irrespective of body shape and proportion. The transducer signals captured by the BioCapture® are transmitted wirelessly to a laptop computer where all signals are displayed in real-time.~The apnea index is given as apneas/hour. Data on apneas greater than or equal to 10 seconds are displayed below. The higher the frequency of apnea, the more severe the breathing abnormality." (NCT01777542)
Timeframe: Every 10 weeks during each of the two 20-week treatment periods

,
InterventionApneas/Hour (Median)
Visit 1 - First Intervention: Apnea IndexVisit 3 - First Intervention: Apnea IndexVisit 5 - First Intervention: Apnea IndexVisit 6 - Second Intervention: Apnea IndexVisit 8 - Second Intervention: Apnea IndexVisit 10 - Second Intervention: Apnea Index
Placebo First, Then rhIGF-17.584.806.937.907.288.91
rhIGF-1 First, Then Placebo4.053.483.073.625.555.56

Rett Syndrome Behavior Questionnaire (RSBQ)

"The RSBQ is a parent-completed measure of abnormal behaviors typically observed in individuals with RTT. Each item, grouped into eight subscales, is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of each subscale is reported. The higher the score, the more severe the symptoms of that subscale in the participant.~The range for each subscale is as follows:~General Mood: 0-16 Body rocking and expressionless face: 0-14 Hand behaviors: 0-12 Breathing Problems: 0-10 Repetitive Face Movements: 0-8 Night-time behaviors: 0-6 Walking Standing: 0-4~The fear/anxiety subscale was used as a primary outcome measure in this study and results can be found in that section." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1- First Intervention: General MoodVisit 2- First Intervention: General MoodVisit 3- First Intervention: General MoodVisit 4- First Intervention: General MoodVisit 5- First Intervention: General MoodVisit 6- Second Intervention: General MoodVisit 7- Second Intervention: General MoodVisit 8- Second Intervention: General MoodVisit 9- Second Intervention: General MoodVisit 10- Second Intervention: General MoodFollow-up: General MoodVisit 1- First Intervention: Body RockingVisit 2- First Intervention: Body RockingVisit 3- First Intervention: Body RockingVisit 4- First Intervention: Body RockingVisit 5- First Intervention: Body RockingVisit 6- Second Intervention: Body RockingVisit 7- Second Intervention: Body RockingVisit 8- Second Intervention: Body RockingVisit 9- Second Intervention: Body RockingVisit 10- Second Intervention: Body RockingFollowup: Body RockingVisit 1- First Intervention: Hand BehaviorsVisit 2- First Intervention: Hand BehaviorsVisit 3- First Intervention: Hand BehaviorsVisit 4- First Intervention: Hand BehaviorsVisit 5- First Intervention: Hand BehaviorsVisit 6- Second Intervention: Hand BehaviorsVisit 7- Second Intervention: Hand BehaviorsVisit 8- Second Intervention: Hand BehaviorsVisit 9- Second Intervention: Hand BehaviorsVisit 10- Second Intervention: Hand BehaviorsFollow-up: Hand BehaviorsVisit 1- First Intervention: Breathing ProblemsVisit 2- First Intervention: Breathing ProblemsVisit 3- First Intervention: Breathing ProblemsVisit 4- First Intervention: Breathing ProblemsVisit 5- First Intervention: Breathing ProblemsVisit 6- Second Intervention: Breathing ProblemsVisit 7- Second Intervention: Breathing ProblemsVisit 8- Second Intervention: Breathing ProblemsVisit 9- Second Intervention: Breathing ProblemsVisit 10- Second Intervention: Breathing ProblemsFollow-up: Breathing ProblemsVisit 1- First Intervention: Repetitive Face MovemVisit 2- First Intervention: Repetitive Face MovemVisit 3- First Intervention: Repetitive Face MovemVisit 4- First Intervention: Repetitive Face MovemVisit 5- First Intervention: Repetitive Face MovemVisit 6- Second Intervention: Repetitive Face MovVisit 7- Second Intervention: Repetitive Face MovVisit 8- Second Intervention: Repetitive Face MovVisit 9- Second Intervention: Repetitive Face MovVisit 10- Second Intervention: Repetitive Face MovFollow-up: Repetitive Face MovementsVisit 1- First Intervention: Night time BehaviorsVisit 2- First Intervention: Night time BehaviorsVisit 3- First Intervention: Night time BehaviorsVisit 4- First Intervention: Night time BehaviorsVisit 5- First Intervention: Night time BehaviorsVisit 6- Second Intervention: Night time BehaviorVisit 7- Second Intervention: Night time BehaviorVisit 8- Second Intervention: Night time BehaviorVisit 9- Second Intervention: Night time BehaviorVisit 10- Second Intervention: Night time BehaviorFollow-up: Night time BehaviorsVisit 1- First Intervention: Walking/StandingVisit 2- First Intervention: Walking/StandingVisit 3- First Intervention: Walking/StandingVisit 4- First Intervention: Walking/StandingVisit 5- First Intervention: Walking/StandingVisit 6- Second Intervention: Walking/StandingVisit 7- Second Intervention: Walking/StandingVisit 8- Second Intervention: Walking/StandingVisit 9- Second Intervention: Walking/StandingVisit 10- Second Intervention: Walking/StandingFollow-up: Walking/Standing
Placebo First, Then rhIGF-17.005.006.005.005.004.005.505.006.004.005.506.005.005.006.005.004.005.005.004.005.004.508.009.008.008.008.009.008.008.008.007.007.506.004.005.005.005.006.004.506.005.006.005.002.002.003.002.003.003.003.003.003.003.002.000.000.000.000.000.000.000.001.000.000.000.002.002.002.002.002.002.002.002.003.001.502.00
rhIGF-1 First, Then Placebo4.003.002.002.003.004.002.002.001.002.502.004.004.003.004.004.004.003.004.003.004.004.008.008.008.009.009.008.009.009.007.009.008.504.004.004.005.004.004.003.003.003.004.003.002.002.003.002.002.003.002.002.002.001.502.001.001.000.000.001.001.000.000.000.000.000.002.002.002.002.002.002.002.002.002.002.002.00

Rett Syndrome Behavior Questionnaire (RSBQ) - Fear/Anxiety Subscale

"The RSBQ is an informant/parent-completed measure of abnormal behaviors typically observed in individuals with RTT, which is completed by a parent/caregiver/LAR. Each item, grouped into eight domains/factors: General mood, Breathing problems, Body rocking and expressionless face, Hand behaviors, Repetitive face movements, Night-time behaviors, Fear/anxiety and Walking/standing), is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of items in each subscale is reported.~For the fear/anxiety subscale, the sum total could be between 0-8. The higher the sum total score, the greater the frequency of fear/anxiety behaviors." (NCT01777542)
Timeframe: Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends

,
Interventionunits on a scale (Median)
Visit 1 - First InterventionVisit 2 - First InterventionVisit 3 - First InterventionVisit 4 - First InterventionVisit 5 - First InterventionVisit 6 - Second InterventionVisit 7 - Second InterventionVisit 8 - Second InterventionVisit 9 - Second InterventionVisit 10 - Second InterventionFollow-up
Placebo First, Then rhIGF-14.005.004.004.003.004.004.003.003.004.003.50
rhIGF-1 First, Then Placebo5.003.003.003.003.004.003.004.003.003.003.50

Vineland Adaptive Behavior Scales, Second Edition (VABS-II)

"The VABS-II is a survey designed to assess personal and social functioning. Within each domain (Communication, Daily Living Skills, Socialization, and Motor Skills), items can given a score of 2 if the participant successfully performs the activity usually; a 1 if the participant successfully performs the activity sometimes, or needs reminders; a 0 if the participant never performs the activity, and a DK if the parent/caregiver is unsure of the participant's ability for an item.~The raw scores in each sub-domain are reported and the ranges for these are as follows: [Communication Domain], Receptive Language=0-40, Expressive Language=0-108, Written Language=0-50; [Daily Living Skills Domain], Personal=0-82, Domestic=0-48, Community=0-88; [Socialization Domain], Interpersonal Relationships=0-76, Play and Leisure Time=0-62, Coping Skills=0-60; [Motor Skills Domain]: Gross Motor Skills=0-80, Fine Motor Skills=0-72.~A higher score indicates more advanced abilities." (NCT01777542)
Timeframe: At the start and end of each 20-week treatment period

,
Interventionunits on a scale (Median)
Visit 1 - First Intervention: ReceptiveVisit 5 - First Intervention: ReceptiveVisit 6 - Second Intervention: Receptive LanguageVisit 10 - Second Intervention: Receptive LanguageVisit 1 - First Intervention: ExpressiveVisit 5 - First Intervention: ExpressiveVisit 6 - Second Intervention: Expressive Lang.Visit 10 - Second Intervention: Expressive Lang.Visit 1 - First Intervention: WrittenVisit 5 - First Intervention: WrittenVisit 6: - Second Intervention Written LanguageVisit 10 - Second Intervention: Written LanguageVisit 1 - First Intervention: PersonalVisit 5 - First Intervention: PersonalVisit 6 - Second Intervention: PersonalVisit 10 - Second Intervention: PersonalVisit 1 - First Intervention: DomesticVisit 5 - First Intervention: DomesticVisit 6 - Second Intervention: DomesticVisit 10 - Second Intervention: DomesticVisit 1 - First Intervention: CommunityVisit 5 - First Intervention: CommunityVisit 6 - Second Intervention: CommunityVisit 10 - Second Intervention: CommunityVisit 1 - First Intervention: Interpersonal Rel.Visit 5 - First Intervention: Interpersonal Rel.Visit 6 - Second Intervention: Interpersonal Rel.Visit 10 - Second Intervention: Interpersonal Rel.Visit 1 - First Intervention: Play and LeisureVisit 5 - First Intervention: Play and LeisureVisit 6 - Second Intervention: Play and LeisureVisit 10 - Second Intervention: Play and LeisureVisit 1 - First Intervention: Coping SkillsVisit 5 - First Intervention: Coping SkillsVisit 6 - Second Intervention: Coping SkillsVisit 10 - Second Intervention: Coping SkillsVisit 1 - First Intervention: Gross MotorVisit 5 - First Intervention: Gross MotorVisit 6 - Second Intervention: Gross MotorVisit 10 - Second Intervention: Gross MotorVisit 1 - First Intervention: Fine MotorVisit 5 - First Intervention: Fine MotorVisit 6 - Second Intervention: Fine MotorVisit 10 - Second Intervention: Fine Motor
Placebo First, Then rhIGF-113.0015.0018.0020.0016.0017.0018.0020.000.000.004.006.009.0010.009.0010.000.000.000.000.000.001.001.002.0018.0018.0019.0020.008.0011.0012.0011.003.002.003.004.0031.0034.0027.0027.006.006.007.005.00
rhIGF-1 First, Then Placebo18.0021.0022.0024.5018.0022.0025.0024.004.005.007.007.008.009.008.509.500.000.000.000.003.003.005.005.0021.0022.0021.0022.5013.0012.0013.0012.503.004.006.004.5010.0010.0011.5010.502.003.004.004.00

Reviews

1 review available for dextroamphetamine and Chronic Insomnia

ArticleYear
Lisdexamfetamine for treatment of attention-deficit/hyperactivity disorder.
    The Annals of pharmacotherapy, 2009, Volume: 43, Issue:4

    Topics: Animals; Attention Deficit Disorder with Hyperactivity; Dextroamphetamine; Humans; Lisdexamfetamine

2009

Trials

12 trials available for dextroamphetamine and Chronic Insomnia

ArticleYear
Long-term effectiveness and safety of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder.
    CNS spectrums, 2008, Volume: 13, Issue:7

    Topics: Administration, Oral; Appetite; Attention Deficit Disorder with Hyperactivity; Child; Dextroamphetam

2008
Lisdexamfetamine in the treatment of attention-deficit/hyperactivity disorder in adults.
    Current psychiatry reports, 2009, Volume: 11, Issue:5

    Topics: Adolescent; Adult; Attention Deficit Disorder with Hyperactivity; Blood Pressure; Central Nervous Sy

2009
Impact of stimulant pharmacotherapy on sleep quality: post hoc analyses of 2 large, double-blind, randomized, placebo-controlled trials.
    The Journal of clinical psychiatry, 2011, Volume: 72, Issue:7

    Topics: Adult; Amphetamines; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulant

2011
Impact of stimulant pharmacotherapy on sleep quality: post hoc analyses of 2 large, double-blind, randomized, placebo-controlled trials.
    The Journal of clinical psychiatry, 2011, Volume: 72, Issue:7

    Topics: Adult; Amphetamines; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulant

2011
Impact of stimulant pharmacotherapy on sleep quality: post hoc analyses of 2 large, double-blind, randomized, placebo-controlled trials.
    The Journal of clinical psychiatry, 2011, Volume: 72, Issue:7

    Topics: Adult; Amphetamines; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulant

2011
Impact of stimulant pharmacotherapy on sleep quality: post hoc analyses of 2 large, double-blind, randomized, placebo-controlled trials.
    The Journal of clinical psychiatry, 2011, Volume: 72, Issue:7

    Topics: Adult; Amphetamines; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulant

2011
Side effects of dexedrine in hyperactive children: operationalization and quantification in a short-term trial.
    Progress in neuro-psychopharmacology & biological psychiatry, 1982, Volume: 6, Issue:2

    Topics: Anorexia; Attention Deficit Disorder with Hyperactivity; Body Weight; Child; Dextroamphetamine; Dose

1982
Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial.
    Pediatrics, 1997, Volume: 100, Issue:4

    Topics: Adolescent; Appetite; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulan

1997
Fenfluramine in the treatment of obesity.
    Lancet (London, England), 1973, Mar-10, Volume: 1, Issue:7802

    Topics: Adult; Appetite Depressants; Body Weight; Clinical Trials as Topic; Constipation; Dextroamphetamine;

1973
Levo(-) amphetamine and dextro(+) amphetamine in the treatment of narcolepsy.
    Journal of neurology, neurosurgery, and psychiatry, 1973, Volume: 36, Issue:6

    Topics: Adult; Amphetamine; Antidepressive Agents; Cataplexy; Dextroamphetamine; Electroencephalography; Eva

1973
Symposium: behavior modification by drugs. II. Psychological effects of stimulant drugs in children with minimal brain dysfunction.
    Pediatrics, 1972, Volume: 49, Issue:5

    Topics: Achievement; Attention Deficit Disorder with Hyperactivity; Bender-Gestalt Test; Brain Damage, Chron

1972
Magnesium pemoline and dextroamphetamine: a controlled study in children with minimal brain dysfunction.
    Psychopharmacologia, 1972, Volume: 26, Issue:4

    Topics: Analysis of Variance; Anxiety; Attention; Attention Deficit Disorder with Hyperactivity; Child; Dext

1972
Effects of dextroamphetamine, chlorpromazine, and hydroxyzine on behavior and performance in hyperactive children.
    The American journal of psychiatry, 1972, Volume: 129, Issue:5

    Topics: Child; Chlorpromazine; Clinical Trials as Topic; Depression; Dextroamphetamine; Dose-Response Relati

1972
Levoamphetamine and dextroamphetamine: comparative efficacy in the hyperkinetic syndrome. Assessment by target symptoms.
    Archives of general psychiatry, 1972, Volume: 27, Issue:6

    Topics: Aggression; Amphetamine; Attention; Body Weight; Child; Clinical Trials as Topic; Dextroamphetamine;

1972
Studies on the hyperactive child. V. The effects of dextroamphetamine and chlorpromazine on behaviour and intellectual functioning.
    Journal of child psychology and psychiatry, and allied disciplines, 1968, Volume: 9, Issue:3

    Topics: Aggression; Child; Child Behavior Disorders; Chlorpromazine; Clinical Trials as Topic; Dextroampheta

1968

Other Studies

11 other studies available for dextroamphetamine and Chronic Insomnia

ArticleYear
Adults with ADHD-without insomnia history have subclinical sleep disturbance but not circadian delay: an ADHD phenotype?
    Journal of attention disorders, 2013, Volume: 17, Issue:7

    Topics: Adult; Aged; Attention Deficit Disorder with Hyperactivity; Dextroamphetamine; Female; Humans; Male;

2013
The effects of dextro-amphetamine on behavioral deficits produced by sleep loss in humans.
    The Journal of pharmacology and experimental therapeutics, 1959, Volume: 127

    Topics: Amphetamine; Amphetamines; Dextroamphetamine; Humans; Sleep; Sleep Initiation and Maintenance Disord

1959
Side effects of dextroamphetamine and methylphenidate in hyperactive children--a brief review.
    Progress in neuro-psychopharmacology & biological psychiatry, 1984, Volume: 8, Issue:1

    Topics: Anorexia; Attention Deficit Disorder with Hyperactivity; Body Weight; Child; Dextroamphetamine; Grow

1984
Clonidine for stimulant-related sleep problems.
    Journal of the American Academy of Child and Adolescent Psychiatry, 1994, Volume: 33, Issue:2

    Topics: Attention Deficit Disorder with Hyperactivity; Child; Clonidine; Dextroamphetamine; Drug Therapy, Co

1994
A possible clonidine-trazodone-dextroamphetamine interaction in a 12-year-old boy.
    Journal of child and adolescent psychopharmacology, 1996,Fall, Volume: 6, Issue:3

    Topics: Antihypertensive Agents; Bradycardia; Central Nervous System Stimulants; Child; Clonidine; Conscious

1996
A prescription refill causes a problem.
    The American journal of nursing, 1998, Volume: 98, Issue:1

    Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Delayed-Act

1998
Psychological medicine. Sleep difficulties.
    British medical journal, 1975, Mar-08, Volume: 1, Issue:5957

    Topics: Aging; Beverages; Dextroamphetamine; Dreams; Female; Humans; Hypnotics and Sedatives; Male; Mental D

1975
Dextroamphetamine for epilepsy.
    JAMA, 1975, Jul-21, Volume: 233, Issue:3

    Topics: Adolescent; Adult; Anorexia; Capsules; Child; Child, Preschool; Dextroamphetamine; Drug Evaluation;

1975
Symposium: behavior modification by drugs. 3. The clinical use of stimulant drugs in children.
    Pediatrics, 1972, Volume: 49, Issue:5

    Topics: Adolescent; Attention Deficit Disorder with Hyperactivity; Child; Dextroamphetamine; Feeding and Eat

1972
Amphetamine-type drugs for hyperactive children.
    The Medical letter on drugs and therapeutics, 1972, Mar-31, Volume: 14, Issue:7

    Topics: Appetite; Attention Deficit Disorder with Hyperactivity; Body Weight; Brain; Child; Dextroamphetamin

1972
On the treatment of narcolepsy.
    The Medical clinics of North America, 1968, Volume: 52, Issue:4

    Topics: Dextroamphetamine; Feeding and Eating Disorders; Humans; Methamphetamine; Methylphenidate; Narcoleps

1968