Last updated: 11/04/2018 04:35:53

Prevention of Seasonal Affective Disorder

GSK study ID

AK130930

See study documents

Clinicaltrials.gov ID

NCT00046241

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Study complete

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

Official title: A 7 Month, Multicenter, Randomized, Double-blind, Placebo-controlled comparison of 150-300mg/day of extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Affective Disorder in subjects with a history of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase

Trial description: This is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).

Primary purpose:

Treatment

Trial design:

Parallel Assignment

Masking:

Not applicable

Allocation:

Randomized

Primary outcomes:

Not applicable

Secondary outcomes:

Not applicable

Interventions:

Drug: Extended-release bupropion hydrochloride

Enrollment:

300

Primary completion date:

2003-30-06

Observational study model:

Not applicable

Time perspective:

Not applicable

Clinical publications:

Collins DM, Crown J, O'Donovan N, Devery A, O'Sullivan F, O'Driscoll L, Clynes M, O'Connor R. Tyrosine kinase inhibitors potentiate the cytotoxicity of MDR-substrate anticancer agents independent of growth factor receptor status in lung cancer cell lines. Invest New Drugs. 2009;

E Benjamin, R Khanna, A Schilling, JJ Flanagan, LJ Pellegrino, N Brignol, Yi Lun, D Guillen, BE Ranes, M Frascella, R Soska, J Feng, L Dungan, B Young, DJ Lockhart, KJ. Valenzano. Co-administration of AT1001 with Recombinant alpha-Gal A Leads to Greater Enzyme Uptake and Substrate Reduction in Fabry Patient-derived Cells and GLA Knockout Mice . Mol Ther. 2012;20(4):717-726.

Goffinet C, Allespach I, Oberbremer L, et al. Pharmacovirological impact of an integrase inhibitor on human immunodeficiency virus type 1 cDNA species in vivo. J Virol. 2009;83(15):7706-7717.

Havaleshko DM, Smith SC, Cho HJ, Cheon S, Owens CR, Lee JK, Liotta LA, Espina V, Wulfkuhle JD, Petricoin EF, Theodorescu D. Comparison of Global versus EGFR pathway profiling for prediction of Lapatinib sensitivity in bladder cancer . Neoplasia. 2009;11(11):1185-1193.

Hightower K, Wang R, Deanda F, et al. Dolutegravir (S/GSK1349572) exhibits significantly slower dissociation than raltegravir and elvitegravir from wild type and integrase inhibitor-resistant HIV-1 integrase-DNA complexes. Antimicrob Agents Chemother. 2011;55(10):4552-4559.

Hongliang Sun, Ying Tsai, Irena Nowak, Jane Liesveld, Yuhchyau Chen. Eltrombopag, a thrombopoietin receptor agonist, enhances human umbilical cord blood hematopoietic stem/primitive progenitor cell expansion and promotes multi-lineage hematopoiesis . Stem Cell Res. 2012;2:77-86.

Johns BA, Kawasuji T, Weatherhead JG, et al. Combining symmetry elements results in potent naphthyridinone (NTD) HIV-1 integrase inhibitors. Bioorg Med Chem Lett. 2011;21(21):6461-6164.

José Ignacio Manzano, Luis Carvalho, José M. Pérez-Victoria, Santiago Castanys* and Francisco Gamarro*. Increased glycolytic ATP synthesis is associated with resistance to Tafenoquine in Leishmania. Antimicrobial Agents and Chemotherapy. 2011;55:1045-52.

Kawasuji T, Johns BA, Yoshida H, et al. Carbamoyl pyridone HIV-1 integrase inhibitors. 1. Molecular design and establishment of an advanced two-metal binding pharmacophore. J Med Chem. 2012;55(20):8735-8744.

Kim HP, Yoon, YK, Kim JW, Han SW, Hur HS, Park J, Lee JH, Oh DY, Im SA, Bang YJ, Kim TY. Lapatinib, a Dual EGFR and HER2 Tyrosine Kinase Inhibitor, Downregulates Thymidylate Synthase by Inhibiting the Nuclear Translocation of EGFR and HER2. PLoS Med. 2009;4(6):e5933.

Luis Carvalho1, Juan Román Luque-Ortega2, José Ignacio Manzano1, Santiago Castanys1, Luis Rivas2*, Francisco Gamarro1*. Tafenoquine, an anti-plasmodial 8-aminoquinoline, targets Leishmania respiratory Complex III and induces apoptosis. Antimicrobial Agents and Chemotherapy. 2010;54:5344-51.

Mayer IA, Arteaga CL. Does Lapatinib Work against HER2-negative Breast Cancers?. Clin. Cancer Res. 2010;16(5):1355-1357.

Modell JG, Rosenthal NE, Harriett AE, Krishen A, Asgharian A, Foster VJ, Metz A, Rockett CB, Wightman DS. Seasonal affective disorder in North America and its prevention by anticipatory treatment with bupropion XL. Biol Psychiatry, 2005; 58:658-667.

Modell, JG, Rosenthal NE. Once-Daily Bupropion XL for the prevention of seasonal major depressive episodes. 43rd Annual Meeting of the American College of Neuropsychopharmacology, San Juan, Puerto Rico, 12-16 December, 2004.

Rhodes MC, Laffan S, Genell C, et al. Assessing a theoretical risk of dolutegravir-induced developmental immunotoxicity in juvenile rats. Toxicol Sci. 2012;130(1): 70-81.

Strecker TE, Qiang S, Zhang Y, Hill JL, Li Yuxin, Wang C, Kim HT, Gilmer TM, Sexton KR, Hilsenbeck SG, Osborne CK, Brown PH. Effect of lapatinib on the development of estrogen receptor-negative mammary tumors in mice. J Natl Cancer Inst. 2009;101(2):107-113.

Tanizaki J, Okamoto I, Takezawa K, Tsukioka S, Uchida J, Kiniwa M, Fukuoka M, Nakagawa K. Synergistic Antitumor Effect of S-1 and HER2-Targeting Agents in Gastric Cancer with HER2 Amplification. Mol Cancer Ther. 2010;9(5):1198-1207.

Vavro C, Hasan S, Madsen H, et al. Prevalent polymorphisms in wild-type HIV-1 integrase are unlikely to engender drug resistance to dolutegravir (DTG, S/GSK1349572). Antimicrob Agents Chemother. 2013;57(3):1379-1384.

Wainberg ZA, Anghel A, Desai AJ, Ayala R, Luo T, Safran B, Fejzo MS, Hecht JR, Slamon DJ, Finn RS. Lapatinib, a Dual EGFR and HER2 Kinase Inhibitor, Selectively Inhibits HER2-Amplified Human Gastric Cancer Cells and is Synergistic with Trastuzumab In vitro and In vivo. Clin Cancer Res. 2010;16(5):1509-1519.

Medical condition

Seasonal Affective Disorder

Product

bupropion

Collaborators

Not applicable

Study date(s)

September 2002 to June 2003

Type

Interventional

Phase

Participation criteria

Sex

Female & Male

Age

18+ years

Accepts healthy volunteers

Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern.

Patient has a current or past history of seizure disorder or brain injury.
Patient has a history or current diagnosis of anorexia nervosa or bulimia.