- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial completion date, Trial primary completion date: Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders (clinicaltrials.gov) - Aug 18, 2020
P2, N=32, Recruiting,
N=33 --> 0 | Trial completion date: Mar 2020 --> Aug 2020 | Not yet recruiting --> Withdrawn | Trial primary completion date: Mar 2020 --> Aug 2020 Trial completion date: Aug 2021 --> Feb 2026 | Trial primary completion date: Aug 2020 --> Feb 2025
- |||||||||| aripiprazole / Generic mfg., Intuniv (guanfacine XR) / Shionogi, Takeda
Clinical, Journal: The Pharmacoepidemiology of Psychotropic Medication Use in Canadian Children from 2012 to 2016. (Pubmed Central) - Aug 13, 2020
Within the second-generation antipsychotics, written prescriptions for aripiprazole increased. Several factors may be involved in stabilization and small decrease in antipsychotic use in recent years, including physician and patient awareness of adverse effects related to antipsychotic use, knowledge implementation strategies advocating short-term and judicious use of antipsychotics in children, and the approval of guanfacine extended release for use in Canada for ADHD in 2013.
- |||||||||| risperidone / Generic mfg., Egis
Clinical, Journal, HEOR: Treatment Patterns, Health Care Resource Utilization, and Health Care Cost Associated with Atypical Antipsychotics or Guanfacine Extended Release in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder in Quebec, Canada. (Pubmed Central) - Aug 13, 2020
In children and adolescents with ADHD who used AAPs or GXR after stimulants, secondary treatment changes were similar with both treatments after 1 year, but discontinuation rates were significantly lower with GXR than with AAPs in the second year. The greater increase in prescription cost with GXR was balanced by a greater increase in overall medical costs with AAPs, resulting in no overall difference in total health care cost between the two treatments.
- |||||||||| Vyvanse (lisdexamfetamine) / Shionogi, Takeda, Intuniv (guanfacine XR) / Shionogi, Takeda
Trial completion date, Trial primary completion date: An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD (clinicaltrials.gov) - Jul 21, 2020
P=N/A, N=160, Recruiting,
The greater increase in prescription cost with GXR was balanced by a greater increase in overall medical costs with AAPs, resulting in no overall difference in total health care cost between the two treatments. Trial completion date: Jul 2020 --> Sep 2022 | Trial primary completion date: Jul 2020 --> Sep 2021
- |||||||||| methylphenidate tablet / Generic mfg.
[VIRTUAL] Review of psychotropic drugs approved for ADHD in Spain (All Screens in Poster Area) - Feb 20, 2020 - Abstract #EPA2020EPA_2207;
In Spain: - Within the group of psychostimulants the short-acting dextroamphetamine is not approved. -In the group of non-psychostimulants, long-acting clonidine is not approved.I Both drugs do not have an official data sheet and there is no evidence that they are pending approval by the Spanish agency of the drug for use in the treatment of ADHD.
- |||||||||| Chantix (varenicline) / Pfizer
Trial initiation date: Combining Varenicline and Guanfacine for Smoking Cessation (clinicaltrials.gov) - Jan 27, 2020
P2, N=140, Not yet recruiting,
As the prominent metabolites in plasma were glucuronide and sulfate of hydroxyguanfacine, which have no associated toxicity concerns, further toxicity studies of the metabolites, for example in animals, were not deemed necessary. Initiation date: Jan 2020 --> Jul 2020
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial completion date, Trial primary completion date: Guanfacine Clinical Trial for Smoking Cessation (clinicaltrials.gov) - Jan 8, 2020
P2, N=250, Active, not recruiting,
Initiation date: Jan 2020 --> Jul 2020 Trial completion date: Nov 2019 --> Nov 2020 | Trial primary completion date: Nov 2019 --> Nov 2020
- |||||||||| guanfacine once-daily (SPD-547) / Takeda
Guanfacine-Extended Release for Treatment of Adults with Adhd (Exhibit Hall C) - Dec 12, 2019 - Abstract #APSARD2020APSARD_25;
GXR may be useful for adults to address ADHD-related impairments such as difficulty in falling asleep, excessive irritability or impulsivity with or without concurrent stimulants. More research is needed to explore the use of GXR for adults with ADHD.
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Guanfacine Extended Release and Mindfulness Skills Therapy (clinicaltrials.gov) - Dec 9, 2019
P4, N=1, Terminated,
More research is needed to explore the use of GXR for adults with ADHD. N=20 --> 1 | Trial completion date: May 2022 --> Dec 2019 | Recruiting --> Terminated | Trial primary completion date: May 2020 --> Dec 2019; Contract terminated
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Clinical, Journal: Distinguishing the efficacy and sedative effects of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. (Pubmed Central) - Aug 28, 2019
In addition, GXR was associated with significant improvements in both inattentive and hyperactive-impulsive symptoms, as assessed by the ADHD-RS-IV subscale scores (nominal p < 0.001) and by the ADHD-RS-IV total score in participants with different ADHD subtypes (nominal p < 0.05). Thus, the efficacy of GXR in children and adolescents with ADHD is not primarily due to sedation, although some contribution to symptom reduction cannot be excluded, especially early in treatment when rates of sedative TEAEs are at their highest.
- |||||||||| Tenex (guanfacine immediate release tablet) / Dr. Reddy's, Intuniv (guanfacine XR) / Shionogi, Takeda
Trial completion date, Trial primary completion date: Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) - Aug 14, 2019
P=N/A, N=120, Recruiting,
Thus, the efficacy of GXR in children and adolescents with ADHD is not primarily due to sedation, although some contribution to symptom reduction cannot be excluded, especially early in treatment when rates of sedative TEAEs are at their highest. Trial completion date: Dec 2019 --> Dec 2021 | Trial primary completion date: Dec 2018 --> Dec 2020
- |||||||||| Tenex (guanfacine immediate release tablet) / Dr. Reddy's, Intuniv (guanfacine XR) / Shionogi, Takeda
Trial completion date, Trial primary completion date: Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance (clinicaltrials.gov) - Aug 14, 2019
P4, N=200, Recruiting,
Trial completion date: Dec 2019 --> Dec 2021 | Trial primary completion date: Dec 2018 --> Dec 2020 Trial completion date: Mar 2019 --> Mar 2021 | Trial primary completion date: Dec 2018 --> Dec 2020
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial primary completion date: ADAPT: ADHD Medication and Predictors of Treatment Outcome (clinicaltrials.gov) - Jul 9, 2019
P=N/A, N=2000, Enrolling by invitation,
Modest changes in pulse rate and blood pressure were not considered by investigators to be clinically meaningful Trial primary completion date: Mar 2019 --> Dec 2020
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Enrollment open, Trial completion date, Trial primary completion date: Noradrenergic Add-on Therapy With Guanfacine (clinicaltrials.gov) - Jun 13, 2019
P3, N=160, Recruiting,
In Part 1 of this 2 part review we discuss the epidemiology and natural history of ADHD, describe the pharmacology of drugs used to treat ADHD, and discuss in detail studies assessing the effects of ADHD drugs on blood pressure, heart or pulse rate and electrocardiographic indices of ventricular repolarization. Not yet recruiting --> Recruiting | Trial completion date: Sep 2019 --> Mar 2021 | Trial primary completion date: Sep 2019 --> Mar 2021
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Enrollment open, Trial initiation date, Trial primary completion date: Guanfacine Extended Release and Mindfulness Skills Therapy (clinicaltrials.gov) - Mar 19, 2019
P4, N=20, Recruiting,
Adversely, BUP has the highest incidence rate of withdrawals and the second highest probability of causing adverse effects as well as lack of efficacy; therefore it should not be recommended as a treatment for ADHD. Not yet recruiting --> Recruiting | Initiation date: Dec 2018 --> Mar 2019 | Trial primary completion date: May 2019 --> May 2020
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial completion date, Trial primary completion date: Guanfacine Clinical Trial for Smoking Cessation (clinicaltrials.gov) - Dec 4, 2018
P2, N=250, Active, not recruiting,
Not yet recruiting --> Recruiting Trial completion date: Apr 2019 --> Nov 2019 | Trial primary completion date: Nov 2018 --> Nov 2019
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial initiation date: Guanfacine Extended Release and Mindfulness Skills Therapy (clinicaltrials.gov) - Oct 15, 2018
P4, N=20, Not yet recruiting,
Trial completion date: Apr 2019 --> Nov 2019 | Trial primary completion date: Nov 2018 --> Nov 2019 Initiation date: Jul 2018 --> Dec 2018
- |||||||||| Vyvanse (lisdexamfetamine) / Shionogi, Takeda, Intuniv (guanfacine XR) / Shionogi, Takeda
Enrollment change, Trial completion date, Trial primary completion date: An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD (clinicaltrials.gov) - Oct 12, 2018
P=N/A, N=160, Recruiting,
Initiation date: Jul 2018 --> Dec 2018 N=30 --> 160 | Trial completion date: Jul 2018 --> Jul 2020 | Trial primary completion date: Jul 2018 --> Jul 2020
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial initiation date: Noradrenergic Add-on Therapy With Guanfacine (clinicaltrials.gov) - Aug 25, 2018
P3, N=160, Not yet recruiting,
N=30 --> 160 | Trial completion date: Jul 2018 --> Jul 2020 | Trial primary completion date: Jul 2018 --> Jul 2020 Initiation date: Sep 2017 --> Sep 2018
- |||||||||| Vyvanse (lisdexamfetamine) / Shionogi, Takeda, Intuniv (guanfacine XR) / Shionogi, Takeda
Enrollment closed, Trial completion date, Trial primary completion date: The Effectiveness of Aerobic Exercise in the Treatment of Adults With Attention Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - Aug 15, 2018
P=N/A, N=70, Active, not recruiting,
Initiation date: Sep 2017 --> Sep 2018 Recruiting --> Active, not recruiting | Trial completion date: Jun 2018 --> Dec 2018 | Trial primary completion date: Jun 2018 --> Dec 2018
- |||||||||| Tenex (guanfacine immediate release tablet) / Dr. Reddy's, Intuniv (guanfacine XR) / Shionogi, Takeda
Trial completion date, Trial primary completion date: Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance (clinicaltrials.gov) - Jun 13, 2018
P4, N=200, Recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Jun 2018 --> Dec 2018 | Trial primary completion date: Jun 2018 --> Dec 2018 Trial completion date: Dec 2018 --> Mar 2019 | Trial primary completion date: Jul 2018 --> Dec 2018
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial initiation date: Guanfacine Extended Release and Mindfulness Skills Therapy (clinicaltrials.gov) - May 4, 2018
P4, N=20, Not yet recruiting,
Trial completion date: Dec 2018 --> Mar 2019 | Trial primary completion date: Jul 2018 --> Dec 2018 Initiation date: Mar 2018 --> Jul 2018
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial completion: PK/PD Comparison of Guanfacine ER and IR (clinicaltrials.gov) - Apr 23, 2018
P2, N=5, Completed,
Initiation date: Mar 2018 --> Jul 2018 Active, not recruiting --> Completed
- |||||||||| Tenex (guanfacine immediate release tablet) / Dr. Reddy's, Intuniv (guanfacine XR) / Shionogi, Takeda
Trial completion date, Trial primary completion date: Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) - Mar 22, 2018
P=N/A, N=120, Recruiting,
Active, not recruiting --> Completed Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2017 --> Dec 2018
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial completion date, Trial primary completion date: PK/PD Comparison of Guanfacine ER and IR (clinicaltrials.gov) - Feb 22, 2018
P2, N=8, Active, not recruiting,
Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2017 --> Dec 2018 Trial primary completion date: Dec 2017 --> Mar 2018 | Trial completion date: Dec 2017 --> Mar 2018
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial initiation date: Guanfacine Extended Release and Mindfulness Skills Therapy (clinicaltrials.gov) - Jan 11, 2018
P4, N=20, Not yet recruiting,
Trial primary completion date: Dec 2017 --> Mar 2018 | Trial completion date: Dec 2017 --> Mar 2018 Initiation date: Nov 2017 --> Mar 2018
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial primary completion date: PK/PD Comparison of Guanfacine ER and IR (clinicaltrials.gov) - Nov 9, 2017
P2, N=8, Active, not recruiting,
Initiation date: Nov 2017 --> Mar 2018 Trial primary completion date: Jul 2017 --> Dec 2017
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Enrollment closed, Trial primary completion date: Guanfacine Clinical Trial for Smoking Cessation (clinicaltrials.gov) - Nov 9, 2017
P2, N=250, Active, not recruiting,
Trial primary completion date: Jul 2017 --> Dec 2017 Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2017 --> Nov 2018
- |||||||||| Intuniv (guanfacine XR) / Shionogi, Takeda
Trial initiation date: Guanfacine Extended Release and Mindfulness Skills Therapy (clinicaltrials.gov) - Nov 1, 2017
P4, N=20, Not yet recruiting,
Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2017 --> Nov 2018 Initiation date: Aug 2017 --> Nov 2017
- |||||||||| Vyvanse (lisdexamfetamine) / Shionogi, Takeda, Intuniv (guanfacine XR) / Shionogi, Takeda
Trial primary completion date: An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD (clinicaltrials.gov) - Sep 15, 2017
P=N/A, N=30, Recruiting,
Initiation date: Aug 2017 --> Nov 2017 Trial primary completion date: Jul 2017 --> Jul 2018
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