venlafaxine extended release / Generic mfg. - LARVOL DELTA

Clinical relevance of venlafaxine ER for generalized anxiety disorder. (PubMed, Psychiatry Clin Neurosci) - "Methodological factors-including the exclusion of placebo responders, the inclusion of participants with comorbid depressive disorders, and a higher rate of discontinuation due to adverse events-further diminish the clinical significance of the findings. Overall, although venlafaxine achieved statistical efficacy, it may lack a clinically meaningful risk-benefit balance."

Clinical • Journal • CNS Disorders • Depression • General Anxiety Disorder • Mood Disorders • Psychiatry

Zydus Lifesciences has received approval from the National Medical Products Administration (NMPA), China for Venlafaxine Extended-Release (ER) Capsules, 75 mg and 150 mg. (Business Standard) - "Venlafaxine ER Capsules are indicated for the treatment of Major Depressive Disorder (MDD), Generalised Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD)."

China approval • Depression • General Anxiety Disorder • Major Depressive Disorder • Social Anxiety Disorder

Evaluation of the Efficacy and Safety of Crisugabalin Capsules versus Placebo and Venlafaxine Extended-Release (XR) Capsules in Chinese Patients with Generalized Anxiety Disorder: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled Clinical Trial (CEASE-GAD). (ChiCTR) - P4 | N=216 | Not yet recruiting | Sponsor: The first affiliated hospital of anhui medical university; The first affiliated hospital of anhui medical university

New P4 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

Multiple Ascending Dose Phase 1 Study of ALA-3000 (clinicaltrials.gov) - P1 | N=44 | Active, not recruiting | Sponsor: Alar Pharmaceuticals Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Mood Disorders • Psychiatry

A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release in Japanese patients with generalized anxiety disorder. (PubMed, Psychiatry Clin Neurosci) - "Venlafaxine ER has a favorable benefit-risk profile in adult Japanese patients with GAD, indicating its potential to improve GAD symptoms as well as patients' function and exert superior anxiolytic effects over placebo without any new safety concern."

Clinical • Journal • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

Comparative Effectiveness Research Trial for Antidepressant Incomplete and Nonresponders With Treatment Resistant Depression (ASCERTAIN-TRD): Effect of Aripiprazole or Repetitive Transcranial Magnetic Stimulation Augmentation Versus Switching to the Antidepressant Venlafaxine on Quality of Life. (PubMed, J Clin Psychiatry) - P4 | "Objective: This study compared the effects of augmenting antidepressants with aripiprazole or repetitive transcranial magnetic stimulation (rTMS) versus switching to venlafaxine XR/duloxetine on quality of life (QoL) among patients with treatment resistant depression (TRD). However, a much smaller than expected sample size for the rTMS group may explain the lack of statistical significance rendering the latter finding of indeterminate nature. Trial Registration: ClinicalTrials.gov identifier: NCT02977299."

HEOR • Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

MDMA-assisted therapy and current treatment options for chronic, treatment-resistant, moderate or higher severity post-traumatic stress disorder: Systematic literature review. (PubMed, PLoS One) - "This systematic review suggests current treatments for PTSD are associated with heterogeneous evidence and the majority do not demonstrate sustained effects. Results from MDMA-AT showed consistent improvements in CAPS, BDI and LOD."

Journal • Review • CNS Disorders • Depression • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Effect of augmentation with aripiprazole or augmentation with repetitive transcranial magnetic stimulation versus switching to the antidepressant venlafaxine extended release/duloxetine on cognition: A comparative effectiveness research trial for antidepressant incomplete and non-responders with treatment-resistant depression (ASCERTAIN-TRD). (PubMed, J Affect Disord) - "Although rTMS augmentation did not reach a statistically significant difference in subjective cognitive improvement, it showed a larger effect size compared to aripiprazole augmentation. Our findings signal that rTMS augmentation may offer a well-tolerated strategy for improving cognition in TRD."

HEOR • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Feasibility Trial of Tele-IPT and Tele-Pharmacotherapy for Patients With Depression and Non-Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=20 | Suspended | Sponsor: New York State Psychiatric Institute | Active, not recruiting ➔ Suspended

Trial suspension • Breast Cancer • CNS Disorders • Depression • Major Depressive Disorder • Oncology • Psychiatry • Solid Tumor

Multiple Ascending Dose Phase 1 Study of ALA-3000 (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Alar Pharmaceuticals Inc.

New P1 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder (clinicaltrials.gov) - P=N/A | N=84 | Completed | Sponsor: First Affiliated Hospital of Zhejiang University | Recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Pharmacological Treatment of Neuropsychiatric Symptoms in Huntington's Disease: A Systematic Review. (PubMed, Mov Disord Clin Pract) - "We conclude that although NPS in HD are common, hardly any clinical trials have addressed their treatment. As a result, convincing evidence that could guide clinical practice is lacking. More focused, and larger, multicenter trials focusing on NPS are urgently needed to generate the knowledge necessary to support the development of evidence-based clinical treatment guidelines."

Journal • Review • CNS Disorders • Depression • Huntington's Disease • Mood Disorders • Movement Disorders • Psychiatry

Feasibility Trial of Tele-IPT and Tele-Pharmacotherapy for Patients With Depression and Non-Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=20 | Active, not recruiting | Sponsor: New York State Psychiatric Institute | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Oncology • Psychiatry • Solid Tumor

A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD (clinicaltrials.gov) - P4 | N=300 | Recruiting | Sponsor: University of Pennsylvania | Trial completion date: Feb 2026 ➔ Jul 2026 | Trial primary completion date: Feb 2026 ➔ Jul 2026

Trial completion date • Trial primary completion date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Study on the spatiotemporal brain network regulation mechanism and efficacy prediction of acupuncture treatment for comorbid depression in migraines based on Granger causality (ChiCTR) - P=N/A | N=216 | Recruiting | Sponsor: Hospital of Chengdu University of Traditional Chinese Medicine/ Chengdu University of Traditional Chinese Medicine; Chengdu University of Traditional

New trial • CNS Disorders • Depression • Migraine • Mood Disorders • Pain • Psychiatry

Pharmacokinetic Bioequivalence and Safety Assessment of Two Venlafaxine Hydrochloride Extended-Release Capsules in Healthy Chinese Subjects Under Fed Conditions: A Randomized, Open-Label, Single-Dose, Crossover Study. (PubMed, Drugs R D) - "Both the test and reference venlafaxine hydrochloride ER capsules were bioequivalent and showed a similar safety and tolerability profile in the population studied."

Journal • PK/PD data • CNS Disorders • Depression • Mood Disorders • Psychiatry

Ten years of maintenance treatment of severe melancholic depression in an adult woman including discontinuation experiences. (PubMed, Fortschr Neurol Psychiatr) - "In this case, high-dose venlafaxine has a particular relapse-preventive (and "recurrence-preventive") effect with good long-term tolerability."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: First Affiliated Hospital of Zhejiang University | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Psilocybin - Are we there yet? (APA 2024) - "Her medication regimen included venlafaxine ER 375 mg daily, bupropion XL 450 mg daily, and lorazepam 1 mg bid and psilocybin use at an unknown dose four times weekly...The patient had previously tolerated venlafaxine ER 300 mg daily, bupropion XL 450 mg daily and trazodone 200 mg nightly without side effects both with and without psilocybin use...Currently, there are not well-established benefits or side effects to the use of psilocybin, especially in an unmonitored setting and in combination with other pharmacotherapies. These cases demonstrate the potential for psilocybin to contribute to serotonin syndrome in the setting of other serotonergic agents and the potential for inducing rather than reducing suicidality in an unmonitored setting."

CNS Disorders • Depression • General Anxiety Disorder • Insomnia • Major Depressive Disorder • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry • Sleep Disorder • Suicidal Ideation

Incident Pain Relief with Esketamine for Depression: Sustained Benefit in Fibromyalgia and Migraine (APA 2024) - "Racemic ketamine, approved for anesthetic and analgesic use for over 50 years, has been used intravenously (IV) off-label for the treatment of major depressive disorder (MDD) for two decades...Her antidepressant regimen at the start of esketamine treatment was bupropion extended-release (XL) 450 mg and venlafaxine extended-release (XR) 225 mg daily...On two occasions when schedules required a longer interval of 11 and then 9 days between doses, the patient rated her breakthrough pain as 6-7 out of 10 in the days beyond the usual one-week interval. Our observations in this case and in our migraine patient noted above have led us to ask whether certain comorbid pain syndromes might favor earlier use of esketamine in some TRD patients."

Anesthesia • Back Pain • CNS Disorders • Depression • Diabetic Neuropathy • Fibromyalgia • Gastrointestinal Disorder • Insomnia • Major Depressive Disorder • Migraine • Mood Disorders • Musculoskeletal Pain • Pain • Peripheral Neuropathic Pain • Psychiatry • Rheumatology • Sleep Disorder

Unexplained recurrent high fever observed in a depressed adolescent. (PubMed, BMC Psychiatry) - "Depression should be considered a potential cause of unexplained recurrent fevers in adolescents, even when the temperature is significantly outside the normal range."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

A Systematic Literature Review of Quality-of-Life Outcomes in Posttraumatic Stress Disorder (PTSD) (ISPOR 2024) - "Sertraline and paroxetine are FDA-approved agents for PTSD, while the APA suggests fluoxetine and venlafaxine as supplementary treatment options. This SLR highlights the compelling impact of FDA-approved or APA-recommended treatments, particularly fluoxetine, venlafaxine ER, and sertraline on enhancing the QoL of PTSD patients."

HEOR • Review • CNS Disorders • Mental Retardation • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Citric acid cross-linking of a hydrogel from Aloe vera (Aloe barbadensis M.) engenders a pH-responsive, superporous, and smart material for drug delivery. (PubMed, RSC Adv) - "Tablets were prepared from CL-ALH as a release retarding agent demonstrating the sustained release of venlafaxine hydrochloride (VFX) for 8 h. Whereas, VFX was released within 4 h from the ALH-based tablet formulation (un-cross-linked material) indicating the prolonged and sustained release behavior of CL-ALH...The CL-ALH-based tablet safely passed through the stomach of a stray dog without any significant erosion and then disintegrated in the small intestine and colon. These findings confirmed that the CL-ALH is an effective excipient for designing a sustained-release drug delivery system for the small intestine and colon."

Journal

Comparative effectiveness research trial for antidepressant incomplete and non-responders with treatment resistant depression (ASCERTAIN-TRD) a randomized clinical trial. (PubMed, Mol Psychiatry) - P4 | "The objective of this study was to compare the effectiveness of augmentation with aripiprazole or repetitive transcranial magnetic stimulation versus switching to the antidepressant venlafaxine XR (or duloxetine for those not eligible to receive venlafaxine) for treatment-resistant depression. Repetitive transcranial magnetic stimulation augmentation was shown to be more effective than switching antidepressants in treatment-resistant depression on the study primary measure. In light of these findings, clinicians should consider repetitive transcranial magnetic stimulation augmentation early-on for treatment-resistant depression.Trial registration: ClinicalTrials.gov, NCT02977299."

Clinical • HEOR • Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder (clinicaltrials.gov) - P=N/A | N=80 | Not yet recruiting | Sponsor: First Affiliated Hospital of Zhejiang University

New trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry