Open-label

Using a primary-care model of treatment, O Malley et al. (2003) initially treated alcohol-dependent patients with open-label naltrexone for 10 weeks, in combination with either CBT or primary care management (PCM), a less intensive, supportive approach. They found no effect of psychosocial treatment on response to treatment, although CBT was associated with a lower risk of drinking. Treatment responders from this study were then randomly assigned to one of two placebo-controlled 24-week continuation studies in... 

J Clin Psychopharmacol 23 294-304, 2003a Kranzler HR, Pierucci-Lagha A, Feinn R, et al Effects of ondansetron in early- vs late-onset alcoholics a prospective, open-label study. Alcohol Clin Exp Res 27 1150-1155, 2003b... 

Somoza EC, Winhusen TM, Bridge TP, et al An open-label pilot study of methylpheni-date in the treatment of cocaine-dependent patients with adult attention deficit/ hyperactivity disorder. J Addict Dis 23 77—92, 2004 Sora 1, Wichems C, Takahashi N, et al Cocaine reward models conditioned place preference can be established in dopamine- and in serotonin-transporter knockout mice. Proc Natl Acad Sci U S A 95 7699-7704, 1998 Soral, Hall FS, Andrews AM, etal Molecular mechanisms of cocaine reward combined dopamine and serotonin transporter knockouts eliminate cocaine place preference. Proc Nad Acad Sci U S A 98 5300-5305, 2001 Spear J, Alderton D Psychosis associated with prescribed dexamphetamine use 0etter). 

Brief interventions have been applied in pharmacotherapy trials with alcohol-dependent individuals as well (Bohn et al. 1994 Kranzler et al. 1997 Kranz-ler et al. 2003 Naranjo et al. 1995 O Connor et al. 1997). In an open-label... 

Stein DS, Fish DG, Bilello JA, Preston SL, Martineau GL, Drusano GL (1996) A 24-week open-label phase I/II evaluation of the HIV protease inhibitor MK-639 (indinavir). AIDS 10 485 92... 

Gorbakov W, Kim H, Gronsky B, Lang W (2005) HCV RNA results from a Phase II, randomized, open-labeled study of omega interferon (IFN) with or without ribavirin in IFN-naive genotype 1 chronic HCV patients. Hepatology 42 705A... 

Kozlowski A, Charles SA, Harris JM (2001) Development of pegylated interferons for the treatment of chronic hepatitis C. BioDrugs 15 419 29 Krown SE, AeppU D, Balfour HH Jr (1999) Phase II, randomized, open-label, community-based trial to compare the safety and activity of combination therapy with recombinant interferon-alpha2b and zidovudine versus zidovudine alone in patients with asymptomatic to mildly symptomatic HIV infection. J Acquir Immune Defic Syndr Hum Retrovirol 20 245-254 LaFleur DW, NardeUi B, Tsareva T, Mather D, Feng P, Semenuk M, Taylor K, Buergin M, Chinchilla D, Roshke V, Chen G, Ruben SM, Pitha PM, Coleman TA, Moore PA (2001) Interferon-kappa, a novel type I interferon expressed in human keratinocytes. J Biol Chem 276 39765-39771... 

The only study conducted in the UK (Forder et al, 1996) employed a retrospective, quasi-experimental design in which patients from an open-label study of sertraline were compared with age- and gender-matched patients prescribed TCAs in a primary care setting. The study found that sertraline was more effective than TCAs (87% versus 74%,... 

Jeste DV, Klausner M, Brecher M, et al (1996). A clinical evaluation of risperidone in the treatment of schizophrenia a ten week open label multicentre trial. Psychopharmacology... 

Dorfman D, Dalton A et al (1999) Treatment of painful distal sensory polyneuropathy in HIV-infected patients with a topical agent results of an open-label trial of 5% lidocaine gel. AIDS 13(12) 1589-1590... 

The current use of IV rt-PA for acute stroke thrombolysis is based on the NINDS rt-PA study, a two-part randomized, double blind, placebo-controlled trial. " This trial was preceded by two open-label, dose-escalation safety studies that suggested that treatment within 180 minutes of stroke onset, and rt-PA dosages no higher than 0.95 mg/kg, was safe and effective. ... 

In a prospective, open-label study, Hill et al. assessed the feasibility of a bridging approach using full-dose IV rt-PA. Following IV infusion of 0.9 mg/kg rt-PA, six patients underwent lAT with rt-PA (maximum dose 20 mg) and one underwent intracranial angioplasty. TIMI 2 or 3 recanalization was achieved in three of these patients. There were no symptomatic ICHs. 

The Interventional Management of Stroke (IMS I) Study was a multicenter, open-labeled, single-arm pilot study in which 80 patients (median NIHSS 18) were enrolled to receive IV rt-PA (0.6 mg/kg, 60 mg maximum, 15% of the dose as a bolus with the remainder administered over 30 minutes) within 3 hours of stroke onset (median time to initiation 140 minutes). " Additional rt-PA was subsequently administered via a microcatheter at the site of the thrombus in 62 of the 80 patients, up to a total dose of 22 mg over 2 hours of infusion or until complete recanalization. Primary comparisons were with similar subsets of the placebo and rt-PA-treated subjects from the NINDS rt-PA Stroke Trial. The 3-month mortality in IMS I subjects (16%) was numerically lower but not statistically different than the mortality of the placebo (24%) or rt-PA-treated subjects (21%) in the NINDS rt-PA Stroke Trial. The rate of symptomatic ICH (6.3%) in IMS I subjects was similar to that of the rt-PA-treated subjects (6.6%) but higher than the rate in the... 

Qureshi Al, Harris-Lane P, Kirmani IF, Janjua N, Divani AA, Mohammad YM, Suarez Jl, Montgomery MO. Intra-arterial reteplase and intravenous abciximab in patients with acute ischemic stroke an open-label, dose-ranging, phase I study. Neurosurgery 2006 59 789-796 [discussion 796-787]. 

Other therapeutic uses of cannabinoid agonists have been reported. The potential of cannabinoids as a treatment for asthma is supported experimentally. A CBi agonist, (i )-methanandamide (21), inhibited nerve growth factor (NGF)-induced airway hyperresponsiveness in vivo [251]. The antipruritic effect of cannabinoids has been reported, the action being mediated by both CBi and CB2 pathways [252]. Treatment with cannabis extract improved urinary tract symptoms of multiple sclerosis patients significantly in an open-label pilot study [253]. 

Si, T. M. Shu, L. (2006). Open-label study the effects of venlafaxine-XR in the treatment of depression. Chinese Journal of Nervous and Mental Diseases, 32(1), 69-71. 

Si, T. M., Shu, L., Yu, X. et al. (2005a). The efficacy and safety of citalopram in treatment of depression a multi-center open-label study. Chinese Journal of Psychiatry, 38(4), 222-6. 

An open-label study of paroxetine and fluoxetine (Alonso et al, 1997) in depressed Hispanic (Mexican descent, n = 13) and non-Hispanic females (n = 13) showed no differences in response rates. At variance with the tricyclic data, Hispanic subjects complained of fewer side effects (2.2 2.0 vs. 5.1 2.5 p < 0.005), but twice as many terminated participation prior to study completion due to non-compliance, intolerable side effects or pregnancy. 

Ferrando et al. (1999) conducted an open-label trial of fluoxetine or sertraline in 30 depressed HIV-positive women (including 16 of Puerto Rican or Dominican descent). No differences in treatment response or adverse effects were found between groups. 

The results from an open-label, pilot study evaluating the efficacy of fluvoxamine for hypochondriasis were recently published (Fallon et al, 2003). The study sample included six Hispanics (subgroup unknown). Significant improvement (57.1%) was noted for the intent-to-treat group (eight out of fourteen) based on physicianrated and self-rated scales. The sample size was too small to identify differences in response or adverse effects by ethnicity. 

A large open-label flexible dose study (Sanchez-Lacay etal, 2001) utilizing nefa-zodone in the treatment of major depression in a predominantly monolingual, Hispanic Caribbean population (Dominican Republic, Puerto Rico, and Cuba) revealed similar response rates and an endpoint mean dosage when compared to previous nefazodone trials with non-Hispanic patients. No serious adverse events were reported, but 42% of the subjects did not complete the study for various reasons including side effects, family, or work responsibilities. 

Alonso, M., Val, E. Rapaport, M. H. (1997). An open-label study of SSRI treatment in depressed Hispanic and non-Hispanic women. /. Clin. Psychiatry, 58, 31. 

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