Open-label studies

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... 

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... 

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%,... 

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. 

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. 

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. 

Finally, Shafran et al. [52] presented recently an open-label study on the efficacy and safety of rifaximin 600 mg/ day for 16 weeks in the treatment of mildly to moderately active CD. At the end of the study, 59% of patients were in remission (as defined by a Crohn s Disease Activity Index, CDAI, <150) with a significant reduction of the... 

Lukas M, Konecny M, Zboril V Rifaximin in patients with mild to moderate activity of ulcerative colitis An open label study. Gastroenterology 2002 122(suppl 1) A434. 

Study Design Treatment, randomized, open label, active control, parallel assignment, safety/efficacy study Official Title A Phase III, Randomized, Open-Label Study of Lopina-vir/Ritonavir Tablets 800/200mg Once-Daily Versus 400/100mg Twice-Daily When Co-administered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced, HIV-1 Infected Subjects Primary Outcome Measures ... 

Atypical Antidepressants. Preliminary open label studies suggested that ven-lafaxine and trazodone might be effective for OCD. However, controlled studies have not yet been completed for venlafaxine, and a controlled study of trazodone (100-200 mg/day) did not find it an effective treatment for OCD. 

L-Tryptophan. Open label studies suggest that tryptophan, the amino acid precursor to serotonin, administered at 500-2000mg/day, may be effective for OCD. This has not been tested in controlled studies. Furthermore, the clinical utility of tryptophan snpplementation has been limited by the association of one batch of tryptophan with the eosinophilia myalgia syndrome. Therefore, we cannot recommend the rontine nse of tryptophan supplementation for OCD. 

Atypical Antidepressants. Initial open label studies of nefazodone and mir-tazapine have been conducted and offer promise, though one negative controlled study with the former has been reported. Further studies are needed. 

Monoamine Oxidase Inhibitors (MAOIs). Early studies also evaluated the effectiveness of the MAOl phenelzine. Phenelzine, relative to TCAs, provided greater benefit for PTSD however, its usefulness is limited by its potential for drug and food interactions. A recent open label study suggests that the reversible MAOI moclobemide might be helpful for PTSD. It is not available in the United States. 

Other agents, clonidine and guanfacine, reduce norepinephrine activity by reducing its release. Open label studies suggest these agents might be helpful for the impulsivity that often accompanies PTSD, but the lone controlled study did not find guanfacine to be effective. 

Anticonvulsants. Several antiseizure medicines have been studied in the treatment of PTSD, and some results have been encouraging. Open label studies, first with carbamazepine (800-1200 mg/day) and later with valproate (500-2000 mg/ day), demonstrated overall improvement in PTSD patients, though not for intrusive recollections per se. Recent open label studies of gabapentin, lamotrigine, tiagabine, and topiramate have suggested these anticonvulsants might also be helpful for some PTSD symptoms. 

With regard to the specific action of antidepressants on the dopaminergic system, there is evidence that buproprion (not marketed in most countries in Western Europe as an antidepressant but available in North America), amineptine and nomifensin (withdrawn because of the rare occurrence of haemolysis) owed their antidepressant efficacy to their ability to increase central dopaminergic function. There are also open label studies to suggest... 

Jacobi A, Braentigam M, Mahler V, Schultz E, Hertl M. (2008) Pimecrolimus 1% cream in the treatment of facial psoriasis A 16-week open-label study. Dermatology 216 133-136. 

There is much controversy over the use of open or open-label studies. It is a golden rule of clinical trial design that, wherever practicable and possible, open studies should not be conducted, but there are circumstances when they can or must be used (see Box 6.2). 

Changes in height (children) In open-label studies, children and adolescents had height increases that were less than expected based on data from age- and sex-matched peers. The difference between observed and expected growth rates was larger for children younger than 12 years of age than for adolescents older than 12 years of age. 

Bolaman Z, Kadikoylu G, Yukselen V, Yavasoglu I, Barutca S, Senturk T. Oral versus intramuscular cobal-amin treatment in megaloblastic anemia a singlecenter, prospective, randomized, open-label study. Clin Ther 2003 25 3124-34. 

Nefazodone is not approved by the FDA for use in children, and the literature on its efficacy in the pediatric population is limited. A small case study of children and adolescents who suffered from treatment-refractory depressive disorders (n = 7 mean age of 12.4) were treated with a mean daily dose of 357 151 mg (3.4 mg/kg) for 13 8 weeks. Over half of the subjects (4/7) were judged to be much to very much improved as rated by the Clinical Global Impression (CGI) (Wilens et al., 1997). More recently, an open-label study of nefazodone in children and adolescents (n = 28) with depression yielded significant improvement in depressive symptoms as measured by the Children s Depression Rating Scale, Revised (Findling et al., 2000). 

Kumra S., Jacobsen, L.K., Lenane, M., Karp, B.I., Frazier, J.A., Smith, A.K., Bedwell, J., Lee, R, Malanga, C.J., Hamburger, S., and Rapoport, J.L. (1998) Childhood-onset schizophrenia an open-label study of olanzapine in adolescents. / Am Acad Child Adolesc Psychiatry 37 377-385. 

McDougle, C.J., Holmes, J.P., Bronson, M.R., Anderson, G.M., Volkmar, F.R., Price, L.H., and Cohen, D.J. (1997) Risperidone treatment of children and adolescents with pervasive developmental disorders a prospective, open-label study. / Am Acad Child Adolesc Psychiatry 36 685-693. 

While some anecdotal evidence has suggested possible benefit from buspirone in children (Zwier and Rao, 1994), in the study by Pfeffer (1997), only 3 of the 19 children who completed the study continued on buspirone after the study. The benefits of buspirone in children with anxiety disorders continue to be unproven. However, open-label studies have demonstrated reductions in anxiety in children with pervasive developmental disorders (Buitelaar et al., 1998). 

Buitelaar, J.K., van der Gaag, R.J., and van der Hoeven, J. (1998) Buspirone in the management of anxiety and irritability in children with pervasive developmental disorder results of an open-label study. / Clm Psychiatry 59 56—59. 

Venlafaxine. Venlafaxine (Effexor) possesses both SSRI and TCA properties (noradrenergic and serotonergic) and is chemically unrelated to other antidepressants. Several open-label studies of adults with ADHD (N = 61) (Adler, et al. 1995 Hornig-Rohan and Amsterdam, 1995 Reimherr et al., 1995 Findling et al., 1996) and one such study of children (Luh et al., 1996) have all shown promising results and support further investigation through controlled trials. 

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