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PubMed1981

The osmotic component of swelling under extended wear soft contact lenses.

Swelling of the cornea during sleep when wearing an extended wear contact lens has a osmotic and hypoxic component. The normal swelling of the cornea during sleep, caused by the change from hypertonic tears of the open eye to the isotonic tears of the closed eye, is about 3%. Under an extended-wear contact lens, there is an additional 6 to 8% swelling of the cornea in the closed eye because the cornea under the contact lens is at an oxygen tension substantially below that present in the palpebral conjunctiva. Data on human subjects wearing extended wear contact lenses are consistent with this allocation of the 8 to 12% total corneal swelling observed upon awakening.

Contact Lenses, Hydrophilic↗

PubMed1999

Klebsiella pneumoniae with extended spectrum beta-lactamase activity associated with a necrotizing enterocolitis outbreak.

BACKGROUND: Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency in newborn infants, affecting primarily premature neonates. Clustering of cases in epidemics is well-described; many are associated with an identifiable pathogen. PATIENTS AND METHODS: Case reports are presented of six neonates seen with NEC during a 2-month period in 1998. All bacterial isolates were subjected to antibiotic testing, determination of MIC and molecular fingerprinting. RESULTS: Klebsiella pneumoniae with extended spectrum beta-lactamase production was isolated from blood cultures of all six patients. In five patients the isolate appeared to be a single clone. The onset of NEC in the patients was earlier, more rapid and more severe than usual. Four of the six required surgery and five required mechanical ventilation. Two of the six patients died, but only one was directly related to a complication of NEC. All of the patients developed severe thrombocytopenia (platelet count <20 x 10(9)/l), and three developed hepatitis. The K. pneumoniae proved difficult to eradicate. Extended courses of multiple antibiotics were administered and measures were introduced to reduce overcrowding and improve infection control. CONCLUSION: The isolation of a single clone of K. pneumoniae with extended spectrum of beta-lactamase activity during an NEC outbreak highlights the need for strict infection control. This organism caused significant morbidity and was difficult to treat.

Anti-Bacterial Agents↗

PubMed1982

The effect of hypothermia and tissue perfusion on extended myocutaneous flap viability.

The salutary effect of hypothermia and tissue perfusion on extending the ischemic tolerance of the canine latissimus dorsi myocutaneous flap was demonstrated in this experimental study. A total of 175 flaps from 89 adult mongrel dogs were elevated with one-half the flaps perfused with iced Collins renal preservation solution. With the exception of control flaps kept at ambient temperature, the remaining flaps were stored at 4 degrees C for periods ranging from 24 to 192 hours followed by transplantation into the groins of recipient dogs, with anastomosis of the thoracodorsal artery and vein in an end-to-side manner to the femoral artery and vein, respectively. The study was divided into two distinct sections. The acute phase involved the transplantation of 77 flaps into random recipient dogs, and following a 3-hour period of systemic perfusion, the flaps were removed, weighed, and sectioned for later histologic study. Progressive increase in flap weight was observed up to 96 hours of hypothermia with a sharp decline in weight at 120 hours of hypothermia. The increase in flap weight in the nonperfused flaps was significantly greater than the previously perfused flaps. Histologically, at 120 hours of hypothermia, loss of vascular integrity was noted, suggestive of a no-reflow phenomenon. In the second, or extended-flap, study, 98 flaps were transplanted into the groins of the original donor animal and allowed to remain in situ for a 2-week period. The flaps were then carefully observed for viability, removed, and sectioned for histologic study. Hypothermic support of up to 96 hours extended viability in both perfused and nonperfused flaps, although beyond this hypothermic period viability was seen only in previously perfused flaps. The clinical implications of this study include hypothermic perfusion of a major-extremity amputation prior to replantation or the temporary storage of a free myocutaneous flap.

Animals↗

PubMed1991

The extended pectoralis major myocutaneous flap: uses and indications.

The vascular territory of the pectoralis major muscle and overlying skin was studied by selective intraarterial dye injections in fresh cadavers. The area of skin overlying the anterior chest and abdominal wall beyond the limits of the pectoralis major muscle that can be elevated as an extended myocutaneous flap was determined. The cadaver injections were evaluated to determine the size and shape of the skin island used to reconstruct defects of the head, neck, and upper trunk with an extended skin paddle off the pectoralis major muscle. Pectoralis muscle flaps with variously shaped skin paddles, some extending beyond the limits of the muscle, were used in 27 patients to cover large soft-tissue defects of the upper thorax, face, and floor of the mouth and as a skin tube to reconstruct the cervical esophagus. The size of the skin paddle ranged from 5 x 7 cm to 26 x 16 cm. All flaps survived completely, and there were no major donor-site complications.

Adult↗

PubMed1999

A new extended external oblique musculocutaneous flap for reconstruction of large chest-wall defects.

A new extended external oblique musculocutaneous flap utilized in the reconstruction of chest-wall defects is described. The flap is drawn as a V-Y rotation flap on the ipsilateral abdominal wall. It is laterally based, and its pedicle coincides with the five lowest costal insertions of the external oblique. The flap extends above the transiliac line, from the posterior axillary line to the linea alba, and includes the dynamic territory of the external oblique muscle. Vascular supply is provided by the musculocutaneous perforating arteries of the intercostal vessels and their subcutaneous branches. The flap is raised medially and includes the anterior sheath of the rectus. Undermining continues between the external and the internal oblique muscles as far as the posterior axillary line. The donor site on the abdominal wall is reinforced by the plication of the internal oblique sheath. This flap was used in 13 patients with major anterior chest-wall excisional defects. The mean chest-wall defect was about 390 cm2. Marginal necrosis with distal skin loss was observed in one patient. All other flaps healed without complications. The extended external oblique musculocutaneous flap differs from other external oblique flaps already described in several aspects that allow it to obtain better functional and aesthetic results.

Aged↗

PubMed1998

Staging and extended resection for pancreatic cancer.

Extended surgery is being widely performed to treat pancreatic cancer in Japan, but it has not been evaluated in the same way as in other countries. We, therefore, compared the Japanese Stage Classification (JPN-SC) with the Union Internationale Contre le Cancer Stage Classification (UICC-SC) in the surgical cases of pancreatic cancer treated in our department and then assessed the results of extended resection and associated problems. Problems existed in the resection rates and actuarial survival rates in stages II and III in the UICC-SC, and the JPN-SC was found to reflect more accurately the outcome. On the other hand, although improvements in curative resection and actuarial survival rate have been achieved as a result of extended resection in Japan, the outcome in JPN-SC surgical stage IVb and highly advanced cases in which these resections proved to be noncurative even though they were classified as surgical stage IVa was extremely poor. In the future, it will be necessary to decide on a single-stage classification that is accepted throughout the world and to conduct prospective studies matched to the degree of tumor progression.

Humans↗

PubMed2002

Is severity of necrotizing pancreatitis increased in extended necrosis and infected necrosis?

INTRODUCTION: We previously reported that organ failure occurs in 50% of patients with necrotizing pancreatitis, that extended pancreatic necrosis (greater than 50% necrosis) is not associated with an increased prevalence of organ failure or infected necrosis, and that the prevalence of organ failure is similar in sterile necrosis and infected necrosis. AIMS To analyze these relations in a larger group of patients and to evaluate other factors that might have prognostic significance. METHODOLOGY: We reviewed 1,110 consecutive cases of acute pancreatitis between January 1, 1995, and January 1, 2000. Necrosis was documented by contrast-enhanced CT. A value less than 0.05 was considered significant. RESULTS: Ninety-nine patients (9%) had necrotizing pancreatitis; 52% had organ failure. Patients with extended pancreatic necrosis did not have increased prevalence of organ failure or infected necrosis but did have an increased need for intubation and an increased mortality rate associated with multiple organ failure. Patients with infected necrosis did not have an increased prevalence of organ failure but did have a marginally increased prevalence of multiple organ failure and increased need for intubation. Overall mortality was 14% and was markedly increased among patients with organ failure at admission (47%) and among patients who had multiple organ failure during the hospitalization (49%). CONCLUSION: Although severity of necrotizing pancreatitis was somewhat increased in extended pancreatic necrosis and infected necrosis, mortality was more strongly linked to organ failure at admission and multiple organ failure during hospitalization.

Female↗

PubMed2003

Variant human pancreas: aberrant uncinate process or an extended mesenteric process.

Variations in the morphology of pancreas are not very common. We observed a rare variant of the uncinate process of the pancreas that extended in the mesentery of the small intestine. After its origin from the lower part of the head of the pancreas, the mesenteric process (MP) passed over the third part of the duodenum to enter the mesentery of the jejunum and ileum and extended up to the level of the pelvic brim. The branches of the superior mesenteric vessels were embedded in the extended MP of the pancreas. This aberrant extension of the pancreas was drained by a narrow duct, which joined the main pancreatic duct inside the head. We did not observe a separate uncinate process arising from the head. On histology normal acini and endocrine cells were observed in the extension. This variant is important as symptoms of pancreatic disease from such extensions may be confused with other commonly encountered acute or chronic abdominal conditions.

Cadaver↗

PubMed1987

Sequential intravenous and twice-daily oral acyclovir for extended prophylaxis of herpes simplex virus infection in marrow transplant patients.

To define an effective and convenient means for providing extended prophylaxis of herpes simplex virus (HSV) infection to chronically immunocompromised patients, we studied a two-part regimen of intravenous, followed by oral, acyclovir after marrow transplantation. Seropositive patients were first given intravenous acyclovir until day 30 after transplant. Intravenous acyclovir (250 mgm/m2) given twice daily to 34 patients during this period was 90% virologically effective among those completing the prophylactic course. A randomized, double-blind comparison of twice-daily oral acyclovir (800 mg) and placebo was then conducted from day 31 to day 75 after transplant in 51 patients. Oral acyclovir significantly delayed the median time to first excretion of HSV when compared with placebo (greater than 100 vs. 70 days after transplant, P = 0.0006) and was completely effective in all patients for the duration of drug administration. Patients receiving extended prophylaxis appeared to have less-severe HSV infection when later recurrences did occur. Sequential intravenous and oral acyclovir given twice daily is an effective and convenient regimen for extended prophylaxis of HSV infection following marrow transplantation, and should be useful in other transplant patients or other chronically immunosuppressed patients as well.

Acyclovir↗

PubMed1990

The impact of extended preservation on clinical liver transplantation.

The introduction of UW solution into clinical transplantation has permitted extended cold storage preservation of the liver. Over a 46-month period, we have performed 308 orthotopic liver transplants (266 primary, 42 retransplants) in 266 recipients. Our experience is divided into cold-storage preservation in Eurocollins (163 transplants in 140 recipients) and UW (145 transplants in 131 recipients) solutions. Donor and recipient factors were comparable between the two groups. The use of UW solution has permitted an increase in the mean preservation time from 5.2 +/- 1.0 [EC] to 12.8 +/- 4.3 [UW] hr (P less than 0.001). The mean total operating time was reduced but intraoperative blood loss was unchanged with UW preservation. The number of transplants performed during the daytime hours has increased dramatically (21.5% [EC] vs. 71% [UW], P less than 0.001). The incidence of primary nonfunction, hepatic artery thrombosis, 1-month graft survival, and early retransplantation were similar in the 2 groups. Initial allograft function as determined by bile production, histology, and clinical assessment were likewise similar. Mean serum bilirubin, transaminase, and prothrombin levels were virtually identical by 5 days posttransplant. The enhanced margin of safety afforded by extended preservation has increased the capability for distant organ procurement and sharing, minimized organ wastage, and improved the efficiency of organ retrieval. With the relaxation of logistical constraints, our rate of liver import has nearly doubled (20.9% [EC] vs. 39.3% [UW], P less than 0.001). Extended preservation has permitted the development of reduced-size liver grafting (n = 12), resulting in a significant reduction in the number of deaths occurring while awaiting transplantation. Therefore, we advocate the use of UW solution with selective extension of preservation based not only on donor and recipient factors but also on manpower, resource, and logistical considerations.

Adenosine↗

PubMed1997

Value of an extended monoethylglycinexylidide formation test and other dynamic liver function tests in liver transplant donors.

Measuring monoethylglycinexylidide (MEGX) formation after intravenous administration of lidocaine in potential organ donors (MEGX test) has been advocated as a useful test to select donor livers for transplantation, but some groups have demonstrated a low test efficacy. We, therefore, investigated the value of an extended MEGX formation test and the value of other dynamic liver function tests, in selecting suitable human donor livers. In 51 human multi-organ donors, we measured elimination of galactose, indocyanine green, and lidocaine, as well as formation of MEGX, at 15, 30, and 60 min after administration of the test substances. In the early postoperative period, the function of the transplanted liver was then classified as good or poor, as defined by a prothrombin time above or below 65% by day 4 and fibrinogen concentration above or below 300 mg/dl by day 7. Donor characteristics and preservation modalities were very similar between the two groups. Galactose, indocyanine green, and lidocaine metabolism failed to predict good or poor graft function in the early postoperative period. MEGX serum concentrations, however, were significantly higher in the group of donors whose organs functioned well in the recipients, as compared with donors whose organs functioned poorly in the recipients. This was true for MEGX concentrations at 15 min (117+/-9 vs. 90+/-9 ng/ml; P=0.03), 30 min (108+/-8 vs. 86+/-8 ng/ml; P=0.04), and 60 min (100+/-6 vs. 73+/-5 ng/ml; P=0.006). Extending the MEGX formation test from 15 to 60 min improved test efficacy. Maximal MEGX concentration in 9 or up to 12 consecutive blood samples, drawn between 3 and 120 min after lidocaine infusion, was also significantly higher in donors whose organs functioned well, than in donors whose organs functioned poorly (129+/-10 vs. 101+/-10 ng/ml; P=0.03). Although the groups with good and poor organ function differed significantly with respect to their MEGX serum concentrations, and although efficacy of the MEGX test was improved by extending the test from 15 to 60 min, the overlap in individual MEGX serum concentrations was still so wide that it is virtually impossible to predict early graft function only on the basis of the MEGX test in the donor. Therefore, the MEGX test, although of potential scientific interest, does not predict early graft function with an accuracy necessary for clinical use.

Adult↗

PubMed2004

Old friends, new ways: revisiting extended lymphadenectomy and neoadjuvant chemotherapy to improve outcomes.

PURPOSE OF REVIEW: Standard therapy for muscle-invasive bladder cancer is radical cystectomy and pelvic-lymph-node dissection. Because 50% of patients will die at 5 years as a result of micrometastases, improvements have been sought to increase the survival rates. Two specific approaches include administration of neoadjuvant chemotherapy or extending the boundaries of the lymph-node dissection. We reviewed the current literature to define present trends and studies that involve these adjunct treatments. RECENT FINDINGS: The benefits of extended lymphadenectomy have been demonstrated by several groups. These include mapping nodal metastatic sites and defining the requisite number of nodes removed to optimize survival. Though not universal, it is frequently concluded that increasing the number of nodes removed improves survival without worse morbidity. Neoadjuvant chemotherapy has been proposed to eliminate occult cancer cells outside the margins of resection. Results have been variable and modest, though emerging data from the Southwest Oncology Group may further support such an approach and improve organ preservation. SUMMARY: Extended lymphadenectomy has consistently shown benefit with minimal morbidity and should be considered--especially in cystectomy patients that are T3. The results from neoadjuvant chemotherapy are more modest. Further studies await further elucidation to confirm this.

Chemotherapy, Adjuvant↗

PubMed2004

Extended middle fossa approach to the petroclival junction and anterior cerebellopontine angle.

OBJECTIVES: This article seeks to demonstrate the use of the extended middle cranial fossa approach in the treatment of tumors arising in the anterior cerebellopontine angle and petroclival region. STUDY DESIGN: We conducted a retrospective chart review. SETTING: Tertiary referral center. PATIENTS: : Ten-year retrospective chart review of over 800 skull base surgical cases demonstrated 16 cases in which the senior author used the extended middle cranial fossa as the sole approach to access the posterior cranial fossa, petroclival junction, or the anterior cerebellopontine angle. There were five males and 11 females, 13 meningiomas, 2 trigeminal schwannomas, and 1 brainstem glioma. Presenting symptoms were dependent on extent of brainstem compression and involvement of surrounding cranial nerves. The symptoms are broken down as follows: hydrocephalus, one; balance disturbance, three; diplopia, five; trigeminal neuralgia, two; hemifacial numbness, one; seizures, one; expressive aphasia, one; and hearing loss, two. RESULTS: Of the 16 patients in this study, one patient needed postoperative care in a skilled nursing facility. Postoperative facial nerve weakness was not experienced in any patient. One patient developed a transient cerebrospinal fluid leak that resolved spontaneously. One patient developed a pseudomeningocele secondary to postoperative hydrocephalus. This was corrected with wound exploration and placement of a ventricular peritoneal shunt. Hearing was not maintained in one patient. Two patients developed new fourth nerve paresis and two patients developed new sixth nerve palsies. There were no postoperative infections and no deaths. CONCLUSIONS: The extended middle cranial fossa approach provides excellent access and exposure to tumors in the anterior cerebellopontine angle and petroclival junction. The approach allows more direct access to the area anterior to the internal auditory canal. The key to the approach is adequate bone removal of the petrous apex to provide exposure down to the inferior petrosal sinus and anteriorly to Meckel's cave and the petroclival junction. Extradural elevation of the temporal lobe with suitable brain relaxation minimizes postoperative complications.

Adult↗

PubMed2004

Ethanol-induced Fos immunoreactivity in the extended amygdala and hypothalamus of the rat brain: focus on cholinergic interneurons of the nucleus accumbens.

BACKGROUND: The primary goal of this study was to investigate the effects of varying doses of ethanol on cellular activation, as measured by Fos immunoreactivity, in brain areas that have been implicated in the reinforcing and anxiolytic effects of substance abuse and dependence, namely, the extended amygdala and hypothalamus. Specific regions examined included the central nucleus of the amygdala, bed nucleus of the stria terminalis, substantia innominata, and nucleus accumbens of the extended amygdala, as well as the paraventricular nucleus of the hypothalamus. The cholinergic interneurons of the nucleus accumbens were of particular interest, because these cells have recently been reported to play a pivotal role in substance abuse. METHODS: Adult Sprague-Dawley rats underwent 10 days of handling and 5 days of habituation. Animals then received an injection of saline or 0.5, 1, or 2 g/kg of ethanol. Rats were perfused 2 hr after the injections, and brain sections were processed for single Fos or dual Fos/choline acetyltransferase immunolabeling procedures. The number of Fos-positive neurons was calculated from a 0.45-mm sample area from each of the brain regions examined. RESULTS: A dose of 2 g/kg of ethanol significantly increased the number of Fos-immunoreactive neurons in the central nucleus of the amygdala by 149%, in the shell nucleus accumbens by 80%, and in the paraventricular nucleus of the hypothalamus by 321%. Additionally, 1 g/kg of ethanol significantly increased the percentage of Fos-immunoreactive cholinergic neurons in the nucleus accumbens by 59%. CONCLUSIONS: The findings reported in this study reveal region-specific and dose-dependent changes in Fos immunoreactivity in the extended amygdala and hypothalamus and, more specifically, an increase in neuronal activation of cholinergic cells in the shell nucleus accumbens. These findings contribute to our current knowledge of the brain areas and cellular microcircuits involved in the underlying basis of substance abuse and dependence.

Amygdala↗

PubMed2005

Extended regimens of the contraceptive vaginal ring: a randomized trial.

OBJECTIVE: To compare the bleeding patterns and tolerability of 3 different extended ring regimens with those of the standard 28-day cycle with 21 days of contraceptive vaginal ring use followed by 7 ring-free days. METHODS: Following a run-in 28-day ring cycle, women were randomized to 1 of 4 regimens: monthly (28-day cycle), every other month (49-day cycle), every third month (91-day cycle), or continuous (364-day cycle). Treatment duration was 1 year. Daily bleeding diary, interval visit questionnaire, and examination data were collected. RESULTS: A total of 561 women were enrolled, 429 were subsequently randomized, and 289 (67.4%) women completed the entire year. All schedules were well tolerated and acceptable to women, but study completion rates were higher for the shorter cycles. Bleeding days were reduced with postponement of the withdrawal bleeding (ring-free) week, but spotting days increased. For example, women using the continuous or 364-day ring cycle reported a median of zero bleeding days but 10-12 days of spotting during the first 3 months of extended use. Unscheduled bleeding during ring use was the lowest with the traditional 28-day cycle. Adverse events, blood pressure, body weight, and laboratory findings were comparable over the 4 treatment groups. CONCLUSION: The combination vaginal contraceptive ring can be used for extended cycles to alter the bleeding schedule. Women willing to tolerate some spotting might choose the longer extensions to have fewer menstrual periods. LEVEL OF EVIDENCE: I.

Adult↗

PubMed2003

Extended trochanteric osteotomy via the direct lateral approach in revision hip arthroplasty.

A review of the results of the extended trochanteric osteotomy through a modified direct lateral approach in revision total hip arthroplasty was done. We reviewed 44 patients (45 procedures) at a minimum of 2 years followup (mean, 3.8 years; range, 2.1-7.2 years). There were 26 men and 18 women with a mean age at the time of surgery of 70.8 years (range, 36.9-90.4 years). Indications for use of the trochanteric osteotomy included facilitation of cement removal (25 procedures), proximal femoral varus deformity (14 procedures), trochanteric malposition (five procedures), and previous trochanteric osteotomies with significant bony overgrowth (three procedures). The mean length of the osteotomy was 133.9 mm. The mean migration of the osteotomized fragment was 2.1 mm (range, 0-20 mm) with significantly more proximal migration seen with the use of cerclage wires when compared with cables. There were two cases of trochanteric escape, for which the patients required repeat open reduction internal fixation. There were two late fractures of the greater trochanter. One femoral component had early subsidence for which the patient required re-revision with a further extended trochanteric osteotomy. The mean time to union of the remaining 40 hips was 10.3 months (range, 6-24 months). There only was one dislocation postoperatively. The extended trochanteric osteotomy through the modified direct lateral approach in revision total hip arthroplasty is a reproducible and reliable technique with a lower dislocation rate but a higher incidence of trochanteric fracture and escape than previously described with its use in the posterior approach.

Adult↗

PubMed2007

Margin-free spondylectomy for extended malignant spine tumors: surgical technique and outcome of 13 cases.

STUDY DESIGN: Description of surgical technique and retrospective review of 13 cases. OBJECTIVES: To describe the surgical technique of margin-free spondylectomy and the outcome of 13 cases and to discuss the advantages and limitations of the procedure. SUMMARY OF BACKGROUND DATA: Recently, spondylectomy became a standard procedure by several pioneers. For extended malignant spine tumors involving pedicles or epidural space, however, performing an "en bloc" resection with a tumor-free margin remains a challenge. METHODS: Our procedure consists of a combined anterior and posterior procedure with one or two stages. In the anterior procedure, tumor vertebrae are covered by the pleura or psoas muscles as a barrier. The posterior procedure includes decompression through the intact posterior elements, coverage of the tumor with all possible soft tissue barriers, and en bloc extirpation by rotating the tumor vertebrae around the spinal cord. We performed this procedure in 13 cases: 3 chondrosarcoma, 3 giant cell tumor, 1 osteosarcoma, 1 chordoma, and 5 metastases. RESULTS: Neurologic status and pain improved in all cases except asymptomatic cases. There was no local recurrence, except in 2 cases (chondrosarcoma with extirpation of 5 vertebrae, chordoma with multiple previous surgeries). Two cases of chondrosarcoma were disease-free 14 years and 13 years after surgery, respectively. CONCLUSION: Although the best chance for a cure in extended malignant tumors of the spine is realized through wide resection, the procedure is not yet standardized. Margin-free spondylectomy is technically demanding, but the procedure can be used with a confidence as a more radical surgery for tumors extending to the epidural space and the unilateral pedicle. A key to success is the surgical technique, including a 360 degree dissection around the tumor vertebrae, instrumentation, and removal of the lesion with all possible soft tissues maintained intact to function as a barrier, like the dura mater.

Adolescent↗

PubMed2006

A randomized, double-blind, placebo-controlled trial of augmentation with an extended release formulation of methylphenidate in outpatients with treatment-resistant depression.

We examined the efficacy and tolerability of augmentation with an extended release formulation of methylphenidate (OROS MPH, Concerta) in patients with major depression who were nonresponders or partial responders to antidepressants. Sixty subjects with treatment-resistant depression (TRD) participated in a 4-week, randomized, double-blind, placebo-controlled study of augmentation with methylphenidate (18-54 mg/d). The preexisting antidepressant dose was unchanged. The primary efficacy measure was change in the 21-item Hamilton Depression Rating Scale from randomization to end of treatment. Data were analyzed with intent-to-treat with last observation carried forward approach. There were no statistically significant differences between the methylphenidate (n = 30) and placebo (n = 30) groups in reduction in 21-item Hamilton Depression Rating Scale scores (drug, -6.9; placebo, -4.7) from baseline to end of treatment (F1,47 = 1.24, P = 0.22), although responders were numerically higher in the extended-release methylphenidate group (40.0%) than in the placebo group (23.3%). On the secondary efficacy measures of changes in Clinical Global Impression-Improvement and Severity scores and Beck Depression Inventory-Second Edition, the drug failed to separate from placebo, although the proportion of responders in the drug group were numerically higher than placebo. There were no significant differences in weight, heart rate, and blood pressure changes between the 2 groups. The common adverse events were loss of appetite, nausea, headache, and anxiety. The mean dose of drug was 34.2 mg/d. The study did not demonstrate a statistically significant benefit for augmentation with methylphenidate in TRD. Combination of methylphenidate with antidepressants was well tolerated. Adequately powered, randomized, controlled trials are necessary to fully evaluate the efficacy of extended-release methylphenidate in TRD.

Adolescent↗