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PubMed2003

Initiating treatment with modafinil for control of excessive daytime sleepiness in patients switching from methylphenidate: an open-label safety study assessing three strategies.

RATIONALE: Modafinil is a first-line wake-promoting medication and a useful therapeutic alternative to psychostimulant medications for excessive daytime sleepiness. OBJECTIVE: This 5-week, randomized, open-label study evaluated three strategies for switching patients from methylphenidate, a commonly used psychostimulant, to modafinil. METHODS: Patients ( n=40) with excessive daytime sleepiness related to narcolepsy, who had received previous treatment with methylphenidate, were switched from methylphenidate to modafinil (200 mg/day followed by 400 mg/day) without a washout period between treatments, with a 2-day washout period between treatments, or by using a taper-down/titrate-up protocol. Adverse events were recorded throughout the study, and Epworth Sleepiness Scale scores were determined at the end of the study. RESULTS: The majority of patients (95%) were successfully switched to modafinil. At the study end point, mean Epworth Sleepiness Scale scores were <12 for each treatment group. All three switching strategies were well tolerated, with adverse events mild or moderate in nature. Adverse events most frequently reported during modafinil treatment were among those seen previously in large-scale, placebo-controlled studies. There were no meaningful differences among the treatment groups in the frequency or severity of adverse events or in their relationship to modafinil treatment. Only one patient discontinued modafinil treatment because of a treatment-related adverse event (i.e. moderate headache); another patient discontinued due to insufficient efficacy. CONCLUSIONS: Switching from methylphenidate to modafinil was well tolerated with or without a washout period or when the methylphenidate dose is gradually tapered during initiation of modafinil therapy. Daytime wakefulness was maintained in patients who have switched from methylphenidate to modafinil. These data suggest that patients with narcolepsy may be switched from methylphenidate to modafinil with few complications and inconveniences.

Adolescent↗
PubMed2003

Relative lack of cognitive effects of methylphenidate in elderly male volunteers.

RATIONALE: Methylphenidate, a dopaminergic and noradrenergic reuptake inhibitor, has been shown in young, healthy adult volunteers to produce pronounced effects on working memory and sustained attention. We were interested in assessing whether similar improvements could be conferred upon elderly volunteers in order to gain a more complete understanding of the effects of age on monoaminergic manipulations of working memory and attention, as well as to explore the potential for pharmacological intervention in attention and executive dysfunction disorders in this age group. OBJECTIVES: The main aim of the study was to characterise the dose-related effects of methylphenidate on a range of neuropsychological functions in elderly healthy volunteers. METHODS: Sixty healthy elderly adult male volunteers received either a single oral dose of placebo, 20 mg or 40 mg methylphenidate prior to performing a variety of tasks designed to assess memory, attention and executive function. A randomised double-blind, between-subjects design was used. RESULTS: Methylphenidate had significant cardiovascular and subjective effects. However, unlike in younger volunteers, no significant effects of drug on working memory (spatial span and spatial working memory), response inhibition (stop-signal) or sustained attention (rapid visual information processing) were seen. Subtle effects on latency similar to those in younger volunteers were identified: both doses of methylphenidate resulted in a slowing in response time during set-shifting and decision-making. CONCLUSIONS: The results of this study demonstrate that, in elderly subjects, the cognitive effects of methylphenidate are grossly attenuated and distinct from the profile previously described in younger volunteers. It is suggested that methylphenidate may not be appropriate as a pharmacological intervention in elderly patient groups, such as those reporting age-related cognitive decline.

Administration, Oral↗
PubMed2005

Methylphenidate increases cigarette smoking.

RATIONALE: Methylphenidate (Ritalin) and d-amphetamine (Dexedrine), stimulants commonly prescribed for behavioral problems associated with attention deficit hyperactivity disorder (ADHD), produce a similar constellation of behavioral effects. The results of previous studies suggest that d-amphetamine increases rates of smoking and the reinforcing effects of smoking. The effects of methylphenidate on smoking have not been assessed although it is the most commonly prescribed pharmacotherapy for ADHD and individuals with ADHD are at increased risk for smoking. OBJECTIVE: In this experiment the acute effects of a range of doses of methylphenidate (5, 10, 20, and 40 mg) and placebo were assessed in ten cigarette smokers who were not attempting to quit and were without ADHD or other Axis I psychiatric disorders. METHODS: Each dose of methylphenidate was tested once, whereas placebo was tested twice. One hour after ingesting drug, participants were allowed to smoke ad libitum for 4 h. Measures of smoking included total cigarettes smoked, total puffs, latency to the first cigarette, and carbon monoxide levels. Snacks and decaffeinated drinks were available ad libitum, and caloric intake during the 4-h smoking session was calculated. RESULTS: Methylphenidate dose dependently increased the total number of cigarettes smoked, number of puffs, and carbon monoxide levels. As expected, methylphenidate dose dependently decreased the number of food items consumed and caloric intake. CONCLUSIONS: The results of this experiment suggest that methylphenidate, like d-amphetamine, increases rates of cigarette smoking.

Adolescent↗
PubMed1999

Dopamine-transporter occupancy after intravenous doses of cocaine and methylphenidate in mice and humans.

OBJECTIVES: Recent studies using positron emission tomography (PET) have established the relationship between an intravenous dose of cocaine and the percentage occupancy of the dopamine transporter in humans, and have documented the requirement of more than 50% occupancy for perception of the "high". The present experiments were conducted to examine dose-occupancy and dose-effect relationships in mice for cocaine and also for methylphenidate, a dopamine uptake blocker used in pediatric psychiatry. METHODS: Percentage occupancies of the dopamine transporter by cocaine and methylphenidate were estimated after intravenous injection in mice from the displacement of in vivo binding of [(3)H]cocaine from the striatum. Locomotor activity was measured in a photocell apparatus. RESULTS: The relationship between drug doses (milligrams of hydrochloride salt per kilogram body weight) and percentage occupancy of the dopamine transporter was indistinguishable for cocaine and methylphenidate, and corresponded to about 50% occupancy at 0.25 mg/kg and about 80% at 1 mg/kg. This was similar to the relationship between drug dose and transporter occupancy, previously measured in human and baboons using [(11)C]cocaine or [(11)C]d-threo-methylphenidate and PET. Methylphenidate increased locomotor activity in the mice substantially more than cocaine at the same dose and the same degree of dopamine-transporter receptor occupancy. CONCLUSIONS: The range of dopamine-transporter occupancy required for behavioral activation in the mice was thus similar to that previously reported for experience of a cocaine- or methylphenidate-induced "high" in human subjects. Our results are consistent with other studies in which both cocaine and methylphenidate were evaluated in animal behavioral assays and were found to have very similar psychopharmacological properties.

Animals↗
PubMed1985

Place preference conditioning with methylphenidate and nomifensine.

The role of central catecholaminergic systems in place preference conditioning produced by methylphenidate and nomifensine was investigated. Several doses of either methylphenidate or nomifensine produced alterations in place preferences, while desipramine (10 mg/kg), a relatively selective noradrenergic uptake inhibitor, was ineffective, Haloperidol (0.15-0.5 mg/kg) did not attenuate place preferences induced with methylphenidate (2.5 and 5.0 mg/kg) or nomifensine (5.0 mg/kg), although conditioning with methylphenidate (5.0 mg/kg) was blocked after injections of a high dose of haloperidol (1.0 mg/kg). Intraventricular injections of 6-hydroxydopamine had no effect on methylphenidate (2.5 mg/kg) induced place preferences. In contrast, pretreatment with haloperidol (0.2 mg/kg) or intraventricular injections of 6-hydroxydopamine attenuated locomotor activity induced by methylphenidate (5.0 mg/kg). These results suggest that methylphenidate and nomifensine produce place preferences via mechanisms that are either qualitatively or quantitatively distinct from their catecholamine-dependent stimulant actions.

Animals↗
PubMed1996

Role of 5-HT1A receptors in the ability of mixed 5-HT1A receptor agonist/dopamine D2 receptor antagonists to inhibit methylphenidate-induced behaviors in rats.

Behavioral effects produced by the indirect-acting dopamine receptor agonist, methylphenidate (40 mg/kg i.p.) were examined in rats after administration of the 5-HT1A receptor agonists (+/-)-8-hydroxy-2-(di-n-propylamino)tetralin (8-OH-DPAT) and flesinoxan, the mixed 5-HT1A receptor agonist/dopamine D2 receptor antagonists buspirone and 1-[-4-fluorobenzoylamino)ethyl]-ethyl]-4-(7-methoxynaphthyl) piperazine (S 14506), the neuroleptics haloperidol and clozapine, and the sigma receptor ligand/partial 5-HT1A receptor agonist alpha-(4-fluorophenyl)-4-(5-fluoro-2-pyrimidinyl)-1-piperazine-butanol (BMY 14802). All of the compounds produced dose-related decreases in methylphenidate-induced stereotyped gnawing, and, as gnawing was inhibited, other methylphenidate-induced responses (i.e. sniffing, rearing and locomotion) appeared. Higher doses of haloperidol and buspirone, but none of the remaining compounds, inhibited these other responses, so that the behavior of the methyphenidate-treated animals became similar to that of normal controls. Pretreatment with the 5-HT1A receptor antagonist N-[2-4-(2-methoxyphenyl)-1-piperazinyl]-ethyl]-N-(2-pyridinyl)- cyclohexanecarboxamide (WAY-100635; 0.63 mg/kg s.c.) blocked the ability of 8-OH-DPAT, S 14506 and flesinoxan to inhibit methylphenidate-induced gnawing, demonstrating the involvement of 5-HT1A receptors in their ability to inhibit methylphenidate-induced behaviors. In contrast, pretreatment with WAY-100635 did not alter the ability of haloperidol, clozapine, buspirone, or BMY 14802 to inhibit methylphenidate-induced gnawing, or in the case of haloperidol and buspirone, to normalize behavior. The results indicate that mixed compounds with 5-HT1A receptor agonist and dopamine receptor antagonist properties can be differentiated on the basis of the ability of WAY-100635 to reverse their effects on methylphenidate-induced behaviors.

Analysis of Variance↗
PubMed1980

Effects of phencyclidine and methylphenidate on d-amphetamine-induced behaviors in reserpine pretreated rats.

The effects and interactions of phencyclidine (PCP), methylphenidate and d-amphetamine on locomotor activity, stereotyped behavior and ataxia in reserpine- and vehicle-pretreated rats were examined. The behaviors of rats receiving PCP alone or in combination with other drugs were quantified along three dimensions (locomotor activity, stereotyped behavior, and ataxia) on scales developed in this laboratory. The behaviors of groups receiving methylphenidate and/or d-amphetamine in treatment combinations other than those including PCP were quantified using a well known d-amphetamine behavioral rating scale. PCP, methylphenidate and d-amphetamine each induced significant increases in locomotor activity and stereotyped behavior when administered alone. Reserpine was found to antagonize PCP-induced locomotor activity and stereotyped behavior, and methylphenidate-induced stereotyped behavior at a dose which either potentiated or had no significant effect upon d-amphetamine-induced behavior (depending upon the scale used). Reserpine also potentiated PCP-induced ataxia. Whereas PCP potentiated the locomotor activity induced by d-amphetamine in both reserpine- and vehicle-pretreated subjects, methylphenidate marginally antagonized d-amphetamine-induced stereotypy in reserpine-pretreated subjects. PCP-induced ataxia in reserpine pretreated subjects appeared moderately reduced in subjects also receiving d-amphetamine. In general, the behavioral effects of PCP appear to be more similar to those of methylphenidate than to those of d-amphetamine, but differences are also found between PCP and methylphenidate. The results are discussed in relation to a behavioral model recently proposed as a method for differentiating indirect dopamine agonists on the basis of their neurochemical mechanisms of action.

Animals↗
PubMed2006

Acute methylphenidate treatments reduce sucrose intake in restricted-fed bingeing rats.

Recent evidence suggests that methylphenidate HCl may be effective at limiting the frequency and the amount of binge eating. The present study investigated if daily treatments with methylphenidate reduced the bingeing-like behavior observed in restricted-fed adult male rats. Three groups (n = 6) received peripheral injections of methylphenidate in doses of 1.5 or 0.75 mg/kg/day, or saline, 3 days prior and 7 days during a previously characterized intermittent feeding regimen that results in a gradual increase of sucrose and food intake. The higher, but not the lower, dose of methylphenidate reduced sucrose intake to an asymptotic level starting after 3 days of the feeding protocol and concurrently led to an increase in the intake of chow. The high dose methylphenidate group also had two-fold lower plasma insulin levels compared with the saline-treated animals at the time of sacrifice on the last day of the feeding regimen. Further histological assays revealed that the methylphenidate treatments, irrespective of the dose used, resulted in selectively higher dopamine transporter and D2-like receptor labeled bindings in the shell region of the nucleus accumbens. These results suggest that relatively low-dose methylphenidate treatments may be effective for the management of binge eating by reducing the intake of palatable foods and may not interfere with short-term regulation of energy balance. These findings further support the notion that the mesoaccumbens dopamine system plays an important role in restricted access-induced sucrose bingeing in this rat model.

Analysis of Variance↗
PubMed2006

Characterization of dopamine-dependent rewarding and locomotor stimulant effects of intravenously-administered methylphenidate in rats.

In general, psychostimulants are thought to exert rewarding and locomotor stimulating effects via increased dopamine transmission in the ventral striatum. However, little is known about the mechanisms underlying the effects of the stimulant drug methylphenidate. The present study examined the putative role of dopaminergic transmission in i.v. methylphenidate reward as measured by conditioned place preference. Rats were shown to exhibit conditioned place preference for i.v. methylphenidate (5 mg/kg, not 2 mg/kg). Administration of the dopamine receptor antagonist cis-flupenthixol (0.1-0.8 mg/kg i.p.), either during conditioning or on test day, dose-dependently attenuated the magnitude of the conditioned place preference. Finally, we examined the effects of bilateral 6-hydroxydopamine lesions of nucleus accumbens core, medial shell or anteromedial olfactory tubercle on the rewarding and locomotor stimulant effects of methylphenidate. Residual dopamine innervation, as assessed by radioligand binding to the dopamine transporter, revealed a significant association between core dopamine innervation and the locomotor stimulant effect of methylphenidate. However, neither core nor medial shell dopamine innervation was related to conditioned place preference magnitude. Instead, conditioned place preference magnitude was associated with dopamine innervation in the anteromedial olfactory tubercle. These results establish a role for dopaminergic transmission in both i.v. methylphenidate conditioned place preference and locomotor stimulation. As well, they suggest that different ventral striatal subregions mediate the rewarding (anteromedial olfactory tubercle) and locomotor stimulant (accumbens core) effects of methylphenidate.

Adrenergic Agents↗
PubMed2004

Behavioral reactivity to a noradrenergic challenge after chronic oral methylphenidate (ritalin) in rats.

Methylphenidate (Ritalin) is routinely used for the treatment of attention-deficit/hyperactivity disorder (ADHD). It is a psychomotor stimulant with pharmacodynamics similar to those established for cocaine and amphetamine with primary activation of the noradrenergic and dopaminergic systems. Long-term exposure to psychostimulants including methylphenidate (MPD) is believed to result in enduring functional changes along both these pathways and various behaviors mediated by these systems may be affected. In the present experiment, the effects of intermittent oral administration of methylphenidate (10 mg/kg) to rats over a 4-week period were subsequently (after a drug washout interval) assessed in three animal models sensitive to noradrenergic manipulation: the elevated plus-maze, predator odor avoidance, and social interaction tests. The behaviors of methylphenidate-experienced animals were compared with untreated controls. Thirty minutes prior to testing, half the animals with each of these histories received an injection of yohimbine hydrochloride (2.0 mg/kg), an alpha2-adrenoreceptor blocker intended to evoke noradrenergic system activation, while the remainder received a saline injection. Yohimbine was expected to reduce both exploration of novel stimuli and interaction with conspecifics, and it was predicted that methylphenidate would potentiate these effects. Relative to saline-tested controls, rats that received both the methylphenidate treatment and the yohimbine challenge exhibited the least exploration in the predator odor test and the lowest duration of interaction with an unfamiliar conspecific partner in the social interaction test. The behavior patterns observed in this group of rats suggest heightened emotionality and defensiveness that are typically seen when rats are administered drugs known to be anxiogenic in human subjects. In the plus-maze, exploratory locomotor activities remained unaltered by either drug while yohimbine decreased risk-assessment behaviors, an effect that remained uninfluenced by methylphenidate pretreatment.

Administration, Oral↗
PubMed2005

Dopamine transporter in attention-deficit hyperactivity disorder normalizes after cessation of methylphenidate.

Attention-deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder of childhood, which is frequently treated with methylphenidate. The short-term response to treatment with methylphenidate is a substantial decrease in dopamine transporter density, with improvement in neuropsychological tests. In this study, single-photon emission computed tomography was used to investigate possible long-term alterations in the cerebral dopamine system after cessation of treatment with methylphenidate in five children with ADHD. Three months after initiation of treatment with methylphenidate, a reduction of the dopamine transporter in the striatal system was observed. Methylphenidate was administered for a period of 9 to 20 months. Follow-up with single-photon emission computed tomography after withdrawal of methylphenidate medication disclosed an increase of dopamine transporter activity comparable with pretreatment values. The observed upregulation of dopamine transporter activity might support the assumption that methylphenidate does not lead to permanent damage of the nigrostriatal dopaminergic pathways.

Attention Deficit Disorder with Hyperactivity↗
PubMed1998

Dose-related effects of MK-801 on acute and chronic methylphenidate administration.

The non-competitive N-methyl-d-aspartate (NMDA) receptor antagonist MK-801 has been shown to modulate both the effects of stimulants, such as amphetamine and cocaine, in producing locomotion and the chronic effects of stimulants in producing sensitization. In this study, we examine the interactions between MK-801 and the stimulant methylphenidate. Three different doses of MK-801 were administered 60 min prior to methylphenidate injection (2.5 mg/kg) and the acute response to MK-801 alone and the coadministration with methylphenidate were characterized. MK-801 alone was found to produce dose-dependent locomotor activation. The 0.15 mg/kg dose of MK-801 had no effect on the response to methylphenidate, while the 0. 3 and 0.6 mg/kg doses augmented the methylphenidate response. The effect of pretreatment with MK-801 on subsequent repeated methylphenidate administration was assessed. For all three doses tested, MK-801 pretreatment blocked the progressive locomotor sensitization expected during repeated methylphenidate administration. These findings suggest that MK-801 may exert a long-lasting effect on learning and memory process that result in a blocking of the development of sensitization.

Animals↗
PubMed1988

An individual double-blind crossover trial for assessing methylphenidate response in children with attention deficit disorder.

To obtain more objective data on response to therapy and to overcome parents', teachers', psychologists', and physicians' concerns about potential overuse, I instituted individual double-blind crossover trials of methylphenidate for children with attention deficit disorder (ADD). Each child is given 0.3 mg/kg/dose twice daily for 2 weeks and placebo for 2 weeks in random order and in double-blind fashion. Parents and teachers record observations of behavior and academic performance. Analysis of 70 trials and follow-up clinical data demonstrated that (1) 51 children showed improvement in one of the 2-week periods and that period corresponded with methylphenidate therapy in 48 (69%); (2) 6 of the 22 who did not respond to methylphenidate experienced worsening of function while taking the drug; (3) history and physical findings were not helpful in predicting methylphenidate response; (4) there were no serious side effects during the trial; and (5) all but three of the responders took methylphenidate for at least 1 year with sustained improvement in behavioral function, academic function, or both. Individual double-blind crossover trials can be used in an office setting to identify objectively which children with ADD respond to treatment with methylphenidate. Because the trial demonstrates to parents, teachers, psychologists, and physicians that methylphenidate is or is not beneficial to a particular child, this clinical tool is associated with a high level of confidence that the drug is being appropriately prescribed.

Adolescent↗
PubMed2001

Assessing the abuse potential of methylphenidate in nonhuman and human subjects: a review.

Methylphenidate (MPH) is widely used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, adolescents, and adults. Methylphenidate is clearly effective for the treatment of ADHD, but there is controversy as to whether it has significant abuse potential like other psychostimulants (e.g., D-amphetamine and cocaine). In general, the drug is believed to be abused at rates much lower than those for other stimulants. The present review examines studies that investigated the behavioral pharmacological profile of methylphenidate and discusses how results from these studies address its abuse liability. Using MEDLINE search terms methylphenidate, drug discrimination, reinforcement, self-administration, subjective effects, subject-rated effects, abuse potential, and abuse liability, along with a review of the references from identified articles, 60 studies were located in which the reinforcing, discriminative-stimulus, or subjective effects of methylphenidate were directly assessed in nonhumans or humans. Forty-eight (80.0%) of the studies reviewed indicate that methylphenidate either functions in a manner similar to D-amphetamine or cocaine (e.g., functions as a reinforcer, substitutes fully in drug discrimination experiments), or produces a pattern of subjective effects suggestive of abuse potential. The results are discussed as they pertain to factors that may account for the apparent discrepancy in abuse rates between methylphenidate and other stimulants, including characterization of actual abuse rates, defining abuse and misuse, pharmacokinetic factors, and validity of abuse liability assays.

Animals↗
PubMed2002

Pretreatment with methylphenidate sensitizes rats to the reinforcing effects of cocaine.

Repeated administration of cocaine produces sensitization to its locomotor-activating effects and increases the rate at which cocaine self-administration behavior is acquired. Methylphenidate is administered clinically on a daily basis, predominantly to children and adolescents, for the treatment of attention-deficit hyperactivity disorder (ADHD). It has been demonstrated previously that pretreatment with methylphenidate administered to periadolescent rats decreased the latency to acquisition of cocaine self-administration. Since methylphenidate is often also administered to adults with ADHD, the present study was conducted to determine the effects of prior administration of methylphenidate (5 or 20 mg/kg/day for 9 days) to adult rats on the rate of acquisition for cocaine self-administration (0.25 mg/kg/infusion). The higher dose of methylphenidate significantly decreased the latency for acquisition of this behavior, suggesting that the rats were sensitized to the reinforcing effects of cocaine after treatment with methylphenidate. These findings add to the growing body of evidence suggesting cross-sensitization between the behavioral effects of psychostimulants. Further, insofar as self-administration is a reliable measure of abuse liability, these data suggest that a short-duration pretreatment with a high dose of methylphenidate to adults increases vulnerability to cocaine abuse.

Animals↗
PubMed2002

Role of dopamine in the therapeutic and reinforcing effects of methylphenidate in humans: results from imaging studies.

Methylphenidate is the most commonly prescribed drug for the treatment of ADHD. We have used positron emission tomography to assess the role that methylphenidate's effects in brain dopamine have on its therapeutic and reinforcing effects. We have documented that in the human brain therapeutic doses of methylphenidate block more than 50% of the dopamine transporters and significantly enhance extracellular DA, an effect that appears to be modulated by the rate of DA release. Thus, we postulate that methylphenidate's therapeutic effects are in part due to amplification of DA signals, that variability in responses is in part due to differences in DA tone and that methylphenidate's effects are context dependent. Methylphenidate-induced increases in DA are also associated with its reinforcing effects but only when this occurs rapidly, as with intravenous administration. Moreover, abuse of methylphenidate is constrained by its long half-life, which we postulate limits the frequency at which it can be administered.

Animals↗
PubMed2002

Prevalence of methylphenidate use and change over a two-year period: a nationwide study of 2- to 11-year-old Canadian children.

OBJECTIVE: To provide age- and sex-specific estimates of methylphenidate use and to determine use changes over a 2-year period. STUDY DESIGN: We examined the first and second data collection cycles of the National Longitudinal Survey of Children and Youth, a Canadian household survey of children. Participants were children aged 2 years to 11 years at both the first and second cycles whose mothers responded; thus, 16,798 (13,059) children were assessed for the first (second) cycle. Logit modeling was used to estimate prevalence of methylphenidate use, to determine sex and age effects on prevalence, and to examine use changes from cycle 1 to 2. RESULTS: Methylphenidate prevalence ranged from 0.09% to 3.89% across 2- to 11-year old children from the first cycle. Boys were 4.6 times more likely than girls to consume methylphenidate. Use was >4 times greater among 6- to 7-year-old children compared with 4- to 5-year-old children and almost 2 times greater among 8- to 9-year-old children compared with 6- to 7-year-old children. Methylphenidate prevalence increased by 36% from cycle 1 to 2. CONCLUSIONS: Methylphenidate prevalence was relatively low. Boys and school-age children had higher rates of methylphenidate use, and use among 2- to 11-year-old children appeared to be increasing over time.

Age Factors↗
PubMed1993

Side effects of methylphenidate and desipramine alone and in combination in children.

OBJECTIVE: To investigate side effects of methylphenidate and desipramine alone and in combination in hospitalized children with symptoms of attention-deficit hyperactivity disorder and depression. METHOD: A double-blind placebo controlled crossover design was used to investigate each medication alone and in combination. Side effect ratings and EKGs were done weekly. Pulse and blood pressure were monitored daily. RESULTS: Nausea, dry mouth, and tremor were present in at least twice as many children on combined methylphenidate and desipramine compared with any other condition. Nausea/vomiting, headaches, other aches, refusal of food, and feeling "tired" were significantly more frequent during the combined methylphenidate plus desipramine condition when compared with either methylphenidate alone or with baseline. Significantly higher ventricular heart rate was found on combined methylphenidate plus desipramine compared with desipramine alone, methylphenidate alone, and baseline. Prolonged PR interval and significantly higher heart rate occurred during desipramine alone compared with baseline. CONCLUSIONS: During the several-month duration of the study, there were more frequent side effects during combined methylphenidate plus desipramine treatment than with either medication alone. Clinically, side effects present during combined medication appeared to be similar to and no more serious than those associated with desipramine alone.

Adolescent↗