WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
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DEXTROSTAT SUMMARY
DEXTROSTAT® CII Dextroamphetamine Sulfate Tablets, USP Rx Only
DextroStat® (dextroamphetamine sulfate) is the dextro isomer of the compound
d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group.
Dextroamphetamine sulfate tablets are indicated:
- In Narcolepsy.
- In Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
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NEWS HIGHLIGHTS
Published Studies Related to Dextrostat (Dextroamphetamine)
A randomized, placebo-controlled trial of sustained-release dextroamphetamine for treatment of methamphetamine addiction. [2011.02] Sixty treatment-seeking individuals with methamphetamine (MA) dependence entered a randomized, placebo-controlled, double-blind clinical trial of oral dextroamphetamine (d-AMP) as a replacement therapy for MA dependence. The subjects took 60 mg sustained-release d-AMP for 8 weeks, during which time they received eight 50-min sessions of individual psychotherapy...
Minocycline attenuates subjective rewarding effects of dextroamphetamine in humans. [2011.01] RATIONALE: Minocycline, a tetracycline antibiotic, interacts with brain glutamate and dopamine neurotransmission. In preclinical studies, minocycline attenuated amphetamine-induced acute dopamine release and subsequent behavioral sensitization. The goal of this study was to determine minocycline's effects on the acute physiological, behavioral, and subjective responses to dextroamphetamine (DAMP) in healthy volunteers... CONCLUSIONS: These findings warrant further studies examining the potential use of minocycline for stimulant addiction.
A randomized, placebo-controlled trial of sustained-release dextroamphetamine for
treatment of methamphetamine addiction. [2011] Sixty treatment-seeking individuals with methamphetamine (MA) dependence entered
a randomized, placebo-controlled, double-blind clinical trial of oral
dextroamphetamine (d-AMP) as a replacement therapy for MA dependence. The
subjects took 60 mg sustained-release d-AMP for 8 weeks, during which time they
received eight 50-min sessions of individual psychotherapy...
Double-blind study of dextroamphetamine versus caffeine augmentation for treatment-resistant obsessive-compulsive disorder. [2009.11] CONCLUSIONS: Larger, double-blind, placebo-controlled trials of both d-amphetamine and caffeine augmentation are needed in OCD subjects inadequately responsive to adequate doses of an SSRI or SNRI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00363298. Copyright 2009 Physicians Postgraduate Press, Inc.
Sustaining executive functions during sleep deprivation: A comparison of caffeine, dextroamphetamine, and modafinil. [2009.02.01] OBJECTIVES: Stimulant medications appear effective at restoring simple alertness and psychomotor vigilance in sleep deprived individuals, but it is not clear whether these medications are effective at restoring higher order complex cognitive capacities such as planning, sequencing, and decision making... CONCLUSIONS: Although comparisons across tasks cannot be made due to the different times of administration, within-task comparisons suggest that, at the doses tested here, each stimulant may produce differential advantages depending on the cognitive demands of the task.
Clinical Trials Related to Dextrostat (Dextroamphetamine)
Dextroamphetamine and tDCS to Improve the Fluency [Recruiting]
The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine
(Dexedrine) and transcranial direct current stimulation with melodic intonation therapy for
treatment of aphasia after stroke. The target population is patients with chronic speech
deficits due to a left hemisphere non-hemorrhagic stroke. Findings from this proposed
project will help in the design of future larger studies. The safety phase will use
cross-over, placebo controlled and single-blinded design. 10 participants with post stroke
chronic non-fluent aphasia will undergo two experiments. To study the safety and effect of
combined dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups,
randomized, sham and placebo controlled, and double-blinded design in which 48 participants
with post stroke chronic non-fluent aphasia will be randomly assigned to receive either 1)
dextroamphetamine therapy with active stimulation, 2) placebo medication with active
stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication
with sham stimulation for the same duration.
Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System Compared to Placebo in Children & Adolescents With ADHD [Completed]
This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the
treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.
Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression [Terminated]
This pilot study will assess the efficacy of several sequential pharmacological treatments
for patients with Refractory Depression.
Dextroamphetamine-Cocaine Behavioral Intervention - 5 [Completed]
Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD [Completed]
The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on
neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD
within a double-blind cross-over design over six weeks. The assessment of ADHD followed
formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A
neuropsychological testbattery and four behavioral questionnaires were selected as efficacy
variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory
control, motor activity), Score (auditory attention), Stroop Test (processing speed,
inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on
each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed
by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by
the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed
by a parent and a teacher Monday till Friday through every week), Test Performance
Questionnaire (completed by the child immediately after each of the three test sessions).
Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will
provide better results than a trial including only Met. a)Met and Dex are efficient as
treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to
Met. b)At an individual level some of the participants will show positive response to one
type of stimulants and no response, mixed response or adverse response to the other type of
stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in
agreement but also add unique information in the assessment of the effect of stimulants.
d)Qb-test is sensitive and valid as a measure of the effect of stimulants.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Dextrostat has an overall score of 10. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| Dextrostat review by 40 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | Mild Side Effects | | Treatment Info |
Condition / reason: | | ADD |
Dosage & duration: | | 20 mg taken once daily for the period of 4 months so far |
Other conditions: | | mild seasonal depression |
Other drugs taken: | | effexor | | Reported Results |
Benefits: | | increased concentration, additional energy, able to complete projects, more patient with my children and now volunteer in my spare time helping children. |
Side effects: | | none |
Comments: | | Was started on 2.5 mg daily and was increased slowly. I never finished school, back then we didnt have add/adhd just lazy students. I wanted to finish school for twenty four years and never could.. I recently took my GED and passed. I am now looking into college courses. I do feel I could benefit from a slight increase in my dose or a longer acting does as I lose concentration around early evening (study time) |
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Page last updated: 2013-02-10
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