Treatment trials

The follow-up for subjects withdrawn from investigational product treatment/trial treatment. Should be decided in advance. 

Sudden Hearing Loss Mullicenter Treatment Trial (SSNHL)... 

Kemper CA, Kent G et al (1998) Mexiletine for HIV-infected patients with painful peripheral neuropathy a double-blind, placebo-controUed, crossover treatment trial. J Acquir Immune Defic Syndr Hum Retrovirol 19(4) 367-372... 

In 2004, the abciximab and rt-PA in Acute Ischemic Stroke Treatment trial treated hve patients with abciximab and half dose of rt-PA within 3 hours of symptom onset. The primary aim was to examine the frequency of SICH at 24 hours. This occurred in one of the five patients. The median NIHSS improvement was 6. 

Abciximab Emergent Stroke Treatment Trial Investigators. Emergency administration of abciximab for treatment of patients with acute ischemic stroke results of a randomized phase 2 trial. Stroke 2005 36 880-890. 

Stroke Trials Registry. Abciximab in Emergent Stroke Treatment Trial - 11. www. strokecenter.org/trials. Accessed on July 15, 2007. 

Many other ocular diseases have similar symptoms. Patients with suggestive symptoms without signs should be placed on a treatment trial. Repeated observations over time may be required for a clinical diagnosis. 

Rausch, J. L., Johnson, M. E. et al. (2002). Initial conditions of serotonin transporter kinetics and genotype influence on SSRI treatment trial outcome. Biol. Psychiatry, 51(9), 723-32. 

AP immunotherapy has been used in both prevention and treatment trials in mutant mice. Both Ap immunization (with Freund s adjuvant) and passive transfer of Ap antibodies reduce levels of AP and plaque burden in... 

Before starting testosterone replacement, patients 40 years and older should be screened for benign prostatic hyperplasia and prostate cancer. To ensure an adequate treatment trial, the patient should continue treatment for 2 to 3 months. 

Commercially viable systems for the decolorisation of spent dyebaths can be based on hydrogen peroxide treatment initiated by UV radiation. A representative selection of six disulphonated monoazo acid dyes and two disazo disulphonated types was exposed for various times in a pilot-scale photochemical reactor of this kind. The controlling parameters were dye structure, pH, peroxide dosage and UV light intensity [39]. In a wider survey of the response of various classes of dyes to the combination of UV radiation and hydrogen peroxide, viable candidates for further in-plant treatment trials were the water-soluble reactive, direct, acid and basic classes. On the other hand, water-insoluble colorants such as disperse and vat dyes did not appear to be viable [40]. 

While a full discussion of treatment planning procedures is beyond the scope of this chapter (for additional discussion, see Chapters 31, 32, and 33 in this volume), several important principles merit elaboration insofar as they apply to combining drug and psychosocial interventions. The discussion here is primarily clinical in orientation. A seminal discussion of methodological issues that arise in comparative treatment trials can be found in a series of articles describing the MTA study (Arnold et ak, 1997a Hinshaw et ak, 1997 Greenhill et ak, 1998 Wells, in press). 

Much of the time, treatment-extant literature doesn t provide much guidance when the patient has multiple comorbidities or already has failed best-practice initial interventions. The few available comparative treatment trials that include both medication and psychotherapy all focus on acute treatment or, less commonly, the heroic management of treatment-refractory patients. This leaves out the majority of patients for whom combined treatment is appropriate if not de rigueur, namely those who are partial responders to initial treatment and/or who require a combination of treatments because of comorbidity. Furthermore, for many clinically important decisions, it is unlikely that there will ever be randomized evidence. For example, how many SSRI trials should precede a clomipramine trial in the partially responsive child with OCD Flow long does one wait before adding a SSRI when treating a child with OCD who is not particularly responsive to weekly CBT ... 

Hundreds of controlled treatment trials of stimulants in children with ADHD have documented efficacy in treating ADHD, as well as improvement of interactions and academic performance. Stimulants have been... 

Frazier, J.A., Biederman, J., Token, M., Feldman, P.D., Jacobs, T.G., Toma, V., Rater, M.A., Tarazi, R.A., Kim, G.S., Garfield, S.B., Sohma, M., Gonzalez-Heydrich, J., Risser, R.C., and Nowlin, Z.M.A. (2001) Prospective open-label treatment trial of olanzapine monotherapy in children and adolescents with bipolar disorder./ Child Adolesc Psychopharmacol 11 239—250. 

Jensen, P.S., Vitiello, B., Leonard, H., and Laughren, T.P. (1994) Design and methodology issues for clinical treatment trials in children and adolescents. Psychopharmacol Bull 30 3-8. 

The results of 40 panic treatment trials conducted between 1975 and 1995 were reviewed. This included studies evaluating TCAs, SRIs, benzodiazepines, anticonvulsants, and propranolol. Three studies report efficacy rates by... 

Because many antidepressant compounds are also effective in panic disorder, we performed a trial of inositol in panic (Benjamin et al. 1995). Twenty-one patients with panic disorder with or without agoraphobia completed a double-blind, random assignment crossover treatment trial of inositol 12 g/ day versus placebo, with 4 weeks in each treatment phase. Frequency of panic attacks and severity of panic disorder and of agoraphobia declined significantly more on inositol than on placebo the effect was comparable to that of imipramine in previous studies. Side effects were minimal. 

Traditional cross-sectional treatment trials infrequently exceeded 4-6 weeks in length. Although trials have grown longer during the past decade and many now often approximate 8-12 weeks, even this length does not provide an adequate time frame for assessment of relapses (months and years are required). 

The parallel-group, double-blind, placebo-controlled study design represents the golden standard of acute treatment trials of depression, mania and anxiety disorders. This design is intended to limit bias, in particular selection and measurement bias. Trials based on this design are expected to provide information about the effect size of a new compound and its side-effect profile. 

Blackburn, I.M., Bishop, S., Glen, A.I.M., Whalley, L.J., Christie, J.E. The efficacy of cognitive therapy in depression a treatment trial using cognitive therapy and pharmacotherapy, each alone and in combination. Br. J. Psvchiatrv 139, 181-189, 1981. 

TABLE 5-23. Benzodiazepines (type/dose range) used in controlled treatment trials of schizophrenia... 

Spiegel DA, Bruce TJ. Benzodiazepines and exposure-based cognitive behavior therapies for panic disorder conclusions from combined treatment trials. Am J Psychiatry 1997 154 773-781. 

Sargent DJ, Conley BA, Allegra C et al. Clinical trial designs for predietive marker validation in eaneer treatment trials. JC// Oncol 2005 23 2020-2027. 

Ross SD, Allen IE, Connelly JE, et al. Clinical outcomes in statin treatment trials a meta-analysis. Arch Intern Med. 1999 159 1793-1802. 

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