This digital document is an article from Clinical Psychiatry News, published by International Medical News Group on September 1, 2003. The length of the article is 576 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: Methylphenidate appears to increase motivation: ADHD patients' concentration improves. (attention-deficit hyperactivity disorder).(Adult Psychiatry)
Author: Kerri Wachter
Publication: Clinical Psychiatry News (Magazine/Journal)
Date: September 1, 2003
Publisher: International Medical News Group
Volume: 31 Issue: 9 Page: 22(1)

Article Type: Product/Service Evaluation

Distributed by Thomson Gale

Objective:

To determine the single-dose pharmacokinetics of 60 mg NWP06, a novel extended-release (ER) liquid formulation of methylphenidate (MPH) compared with 30 mg immediate-release (IR) liquid MPH, dosed at Hours 0 and 6, in adults.

Methods:

After institutional review board approval, 30 healthy subjects aged 18 to 68 years were enrolled in this open-label, crossover study and randomly assigned to receive NWP06/IR MPH after an overnight fast. Blood samples were collected prior to dose at Hour 0 and at post-dose hours 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 4, 5, 6, 6.5, 7, 7.33, 7.67, 8, 8.5, 9, 10, 12, 14, 16, 24, and 36. Plasma concentrations of d- and l-MPH were determined and pharmacokinetic parameters were calculated. Safety assessments included vital signs, electrocardiogram, laboratory evaluations, adverse event (AE) collection, and suicidality assessment.

Results:

Twenty-eight subjects completed the study. The AUC0-∞ of d-MPH for NWP06 and IR MPH were 143.65 and 153.31 ng-hr/mL, respectively. The peak plasma concentration, Cmax (ng/mL), was 13.61 for NWP06 and 20.94 for IR MPH. The half-life of NWP06 was 5.65 hours and Tmax was 5 hours. For IR MPH, the half-life was 3.74 hours and Tmax was 7.33 hours. Vital sign changes were in the expected range for MPH and there were no clinically significant laboratory or ECG changes. The most common AEs reported were headache, dizziness, palpitations, nausea, and nervousness.

Conclusions:

A single dose of 60 mg NWP06 is equally bioavailable to two 30-mg doses of IR MPH. NWP06 has a lower peak concentration than IR MPH. Both study treatments were well tolerated, as all AEs were rated as mild in this healthy adult population.

Original Publication Date: September 2010

Objective:

To determine the single-dose pharmacokinetics of 60 mg NWP06, a novel extended-release (ER) liquid formulation of methylphenidate (MPH) compared with 30 mg immediate-release (IR) liquid MPH, dosed at Hours 0 and 6, in adults.

Methods:

After institutional review board approval, 30 healthy subjects aged 18 to 68 years were enrolled in this open-label, crossover study and randomly assigned to receive NWP06/IR MPH after an overnight fast. Blood samples were collected prior to dose at Hour 0 and at post-dose hours 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 4, 5, 6, 6.5, 7, 7.33, 7.67, 8, 8.5, 9, 10, 12, 14, 16, 24, and 36. Plasma concentrations of d- and l-MPH were determined and pharmacokinetic parameters were calculated. Safety assessments included vital signs, electrocardiogram, laboratory evaluations, adverse event (AE) collection, and suicidality assessment.

Results:

Twenty-eight subjects completed the study. The AUC0-∞ of d-MPH for NWP06 and IR MPH were 143.65 and 153.31 ng-hr/mL, respectively. The peak plasma concentration, Cmax (ng/mL), was 13.61 for NWP06 and 20.94 for IR MPH. The half-life of NWP06 was 5.65 hours and Tmax was 5 hours. For IR MPH, the half-life was 3.74 hours and Tmax was 7.33 hours. Vital sign changes were in the expected range for MPH and there were no clinically significant laboratory or ECG changes. The most common AEs reported were headache, dizziness, palpitations, nausea, and nervousness.

Conclusions:

A single dose of 60 mg NWP06 is equally bioavailable to two 30-mg doses of IR MPH. NWP06 has a lower peak concentration than IR MPH. Both study treatments were well tolerated, as all AEs were rated as mild in this healthy adult population.

Original Publication Date: September 2010

This digital document is an article from Clinical Psychiatry News, published by International Medical News Group on November 1, 2004. The length of the article is 682 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: ADHD comparison favors methylphenidate.(Child/Adolescent Psychiatry)(Attention-deficit hyperactivity disorder)
Author: Mitchel L. Zoler
Publication: Clinical Psychiatry News (Magazine/Journal)
Date: November 1, 2004
Publisher: International Medical News Group
Volume: 32 Issue: 11 Page: 33(1)

Distributed by Thomson Gale

This digital document is an article from Clinical Psychiatry News, published by Thomson Gale on December 1, 2006. The length of the article is 549 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: Concerta effective for ADHD plus epilepsy in small study.(attention deficit hyperactivity disorder)(use of osmotic release oral system methylphenidate )
Author: Doug Brunk
Publication: Clinical Psychiatry News (Magazine/Journal)
Date: December 1, 2006
Publisher: Thomson Gale
Volume: 34 Issue: 12 Page: 30(1)

Distributed by Thomson Gale

This digital document is an article from Clinical Psychiatry News, published by International Medical News Group on December 1, 2001. The length of the article is 757 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: Data on Extended-Release Methylphenidate Grow. (Side Effects Related to Dose).
Author: Sherry Boschert
Publication: Clinical Psychiatry News (Magazine/Journal)
Date: December 1, 2001
Publisher: International Medical News Group
Volume: 29 Issue: 12 Page: 14(2)

Article Type: Product/Service Evaluation

Distributed by Thomson Gale

Methylphenidate (MPH) is one of the most commonly prescribed drugs in the United States. MPH is a psychostimulant that inhibits the dopamine (DA) and norepinephrine (NE) transporters to increase extracellular monoamines. Abuse rates of MPH are increasing as prescription rates increase, but the effects of high-dose, chronic MPH exposure have not been well defined. In particular, the effects of MPH on serotonin (5-HT) systems have not been well investigated. While MPH itself does not have affinity for the 5-HT transporter, DA and 5-HT systems have many points of interaction, particularly in the mesolimbic DA system, an area associated with the rewarding and reinforcing properties of drugs. Thus, our studies focused on the interactions of DA and 5-HT systems at the level of the ventral tegmental area (VTA) and nucleus accumbens (NAc) following chronic MPH treatment in mice. The experiments utilized locomotor activity measures, conditioned place preference, single and dual probe in vivo microdialysis, radioligand binding, and behavioral tests for depressive like behaviors to examine the effects of chronic MPH. Our studies showed that chronic MPH alters DA/5-HT system interactions in the mesolimbic DA system. The alterations are such that elevations in 5-HT produced a stronger influence over DA neuron firing. Specifically, we found that the serotonin agonist fluoxetine increased DA in the NAc and produced place preference in MPH treated animals. Further investigations traced these changes to the VTA, where increasing 5-HT in the VTA produced increased DA cell firing when stimulated. Our studies subsequently examined which 5-HT receptors are responsible for this change. Of the five 5-HT receptors examined using locomotor activity, conditioned place preference, and in vivo microdialysis, the 5-HT1A and 1B receptors showed sensitization, and it appears that alterations in these receptors are primarily responsible for the influence of 5-HT over the DA system following MPH exposure. Finally, these studies have determined that chronic MPH produced depressive-like effects during withdrawal, and behavioral and neurochemical sensitization following exposure. Taken together, the investigations conducted in this thesis showed novel effects of MPH on 5-HT/DA interactions, with implications for the consequences of MPH abuse in humans.

This digital document is an article from Clinical Psychiatry News, published by International Medical News Group on June 1, 2002. The length of the article is 427 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: Effects of once-daily methylphenidate appear to last throughout school day. (Rapid Onset Plus Sufficient Duration).(Brief Article)
Author: Mary Ann Moon
Publication: Clinical Psychiatry News (Magazine/Journal)
Date: June 1, 2002
Publisher: International Medical News Group
Volume: 30 Issue: 6 Page: 10(1)

Article Type: Brief Article

Distributed by Thomson Gale

Objectives:

To explore the clinical and health-related quality of life (HRQoL) outcomes in children/adolescents with attention-deficit/hyperactivity disorder (ADHD) who required a therapy switch from immediate-release (IR) methylphenidate (MPH) and were initiated on Osmotic Release Oral System (OROS®) MPH.

Methods:

Prospective, noninterventional study including patients (aged 6–18 years) with a confirmed diagnosis of ADHD who transitioned from IR MPH to OROS® MPH based on medical needs. Patients were transitioned to OROS® MPH and were followed for 12 weeks. Attention-deficit/hyperactivity disorder symptoms, functional outcomes, HRQoL, and tolerability were assessed throughout the study.

Results:

598 patients entered the intention-to-treat analysis. The mean OROS® MPH starting dose was 29.5 ± 12.0 mg/day, increasing slightly to 33.5 ± 13.2 mg/day at final visit. Compared with baseline, there were significant (all P < 0.0001) symptomatic, functional, and HRQoL improvements after transitioning from IR MPH to OROS® MPH as assessed by the Conners’ Parent Rating Scale (from 29.0 ± 10.5 to 19.5 ± 11.1), Children’s Global Assessment Scale (by 11.0 ± 13.3), and Inventory for Assessing Quality of Life (ILC) LQ0–28 scores (parents’ rating from 17.2 ± 3.9 to 19.4 ± 4.0; patients’ rating from 18.7 ± 4.0 to 20.5 ± 3.9). Overall, no significant changes in quality of sleep or appetite were observed. More than 70% of parents and physicians rated the effectiveness of OROS® MPH as at least “good” and were at least “satisfied” with OROS® MPH. The most common treatment-emergent adverse events were insomnia and anorexia. No clinically relevant changes in body weight or vital signs were observed.

Conclusions:

this naturalistic setting, transitioning from IR MPH to OROS® MPH, in patients who showed previously insufficient response and/or poor tolerability, was successful. Patients’ and parents’ HRQoL as well as burden of disease showed a clinically relevant improvement. OROS® MPH was generally safe and well tolerated.

Objectives:

To explore the clinical and health-related quality of life (HRQoL) outcomes in children/adolescents with attention-deficit/hyperactivity disorder (ADHD) who required a therapy switch from immediate-release (IR) methylphenidate (MPH) and were initiated on Osmotic Release Oral System (OROS®) MPH.

Methods:

Prospective, noninterventional study including patients (aged 6–18 years) with a confirmed diagnosis of ADHD who transitioned from IR MPH to OROS® MPH based on medical needs. Patients were transitioned to OROS® MPH and were followed for 12 weeks. Attention-deficit/hyperactivity disorder symptoms, functional outcomes, HRQoL, and tolerability were assessed throughout the study.

Results:

598 patients entered the intention-to-treat analysis. The mean OROS® MPH starting dose was 29.5 ± 12.0 mg/day, increasing slightly to 33.5 ± 13.2 mg/day at final visit. Compared with baseline, there were significant (all P < 0.0001) symptomatic, functional, and HRQoL improvements after transitioning from IR MPH to OROS® MPH as assessed by the Conners’ Parent Rating Scale (from 29.0 ± 10.5 to 19.5 ± 11.1), Children’s Global Assessment Scale (by 11.0 ± 13.3), and Inventory for Assessing Quality of Life (ILC) LQ0–28 scores (parents’ rating from 17.2 ± 3.9 to 19.4 ± 4.0; patients’ rating from 18.7 ± 4.0 to 20.5 ± 3.9). Overall, no significant changes in quality of sleep or appetite were observed. More than 70% of parents and physicians rated the effectiveness of OROS® MPH as at least “good” and were at least “satisfied” with OROS® MPH. The most common treatment-emergent adverse events were insomnia and anorexia. No clinically relevant changes in body weight or vital signs were observed.

Conclusions:

this naturalistic setting, transitioning from IR MPH to OROS® MPH, in patients who showed previously insufficient response and/or poor tolerability, was successful. Patients’ and parents’ HRQoL as well as burden of disease showed a clinically relevant improvement. OROS® MPH was generally safe and well tolerated.