Las personas con el VIH corren un mayor riesgo de padecer algunas enfermedades de salud mental que las personas que no tienen el virus. Los problemas de salud mental se pueden tratar y las personas con estos tipos de problemas se pueden recuperar. La mala salud mental no es lo mismo que la enfermedad mental. Una persona puede tener mala salud mental y no tener una enfermedad mental diagnosticada. Cualquier persona puede tener problemas de salud mental.
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Print Download. Examples: Cancer AND drug name. Pneumonia AND sponsor name. How to search [pdf]. For these items you should use the filters and not add them to your search terms in the text field. Print Download Summary. Review by the Competent Authority or Ethics Committee in the country concerned.
As of 1. EU Clinical Trials Register. Search tools. Select Date Range: to. Select Rare Disease:. IMP with orphan designation in the indication.
Orphan Designation Number:. Results Status: Trials with results Trials without results. Clear advanced search filters. Date on which this record was first entered in the EudraCT database:.
Title of the trial for lay people, in easily understood, i. The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy.
Migraine and major depressive disorder MDD. To evaluate the efficacy of monthly mg sc fremanezumab in adult patients with migraine and MDD. The patient is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in this protocol. The patient is male or female and 18 to 70 years of age, inclusive. Prior to the screening visit V1 , the patient has a month history of either: -migraine according to ICHD-3 criteria or -headache consistent with migraine ie, migraine diagnosis not better accounted for by another ICHD-3 diagnosis e.
The patient agrees not to initiate any migraine preventive medications during the study. Patients may take a single medication prescribed for the treatment of depression as long as the dose of that medication has been stable for at least 8 weeks prior to the screening visit V1 and expects to remain at the stable dose throughout the study.
The patient has a PHQ-9 score of at least 10 at the screening visit V1. The patient has a Mini Mental State Examination score of at least 26 points at the screening visit V1. The patient is in good health in the opinion of the investigator as determined by medical evaluation, including medical and psychiatric history, physical examination, laboratory tests, and cardiac monitoring. Women may be included only if they have a negative serum beta-human chorionic gonadotropin test at the screening visit V1 , are sterile or postmenopausal, and are not lactating not applicable for patients participating in safety follow-up only.
Women of child-bearing potential whose male partners are potentially fertile ie, no vasectomy must use highly effective birth control methods for the duration of the study and for 6 months after discontinuation of IMP. For the purpose of this study, vasectomized men must use a condom if their partners are of child-bearing potential.
The patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study, and to return to the clinic for the follow-up evaluations, as specified in this protocol.
El paciente es capaz de dar consentimiento informado por escrito con firma que incluya cumplimiento de los requisitos y restricciones indicadas en el protocolo. The patient uses medications containing opioids incl. The patient has failed 4 or more different medication classes to treat depression.
The patient has used electroconvulsive therapy at any time. The patient has clinically significant disease e. The patient has a history of hypersensitivity reactions to injected proteins, incl. The patient has participated in a clinical study of a new chemical entity or a prescription medicine within 2 months of the screening visit V1 or 3 months in case of biologics if the half-life of the biologics is unknown or 5 half-lives, whichever is longer, or is currently participating in another study of an IMP or a medical device.
The patient has failed treatment with any monoclonal antibodies targeting the CGRP pathway or have taken the medications within 5 half-lives of the screening visit or take them during the study. The patient has any finding in the baseline lead electrocardiogram considered clinically significant in the judgment of the investigator. The patient has any finding that, in the judgment of the investigator, is a clinically significant abnormality, incl.
The patient has any disorder that may interfere with the absorption, distribution, metabolism, or excretion of IMP. The patient is vulnerable. The patient previously participated in this study.
El paciente ha utilizado terapia electroconvulsiva. El paciente es vulnerable z. El paciente ha participado anteriormente en este estudio aa. Mean change in the monthly average number of migraine days from the day baseline period during the week period after the first dose of study drug.
The week double-blind treatment phase is followed by a week open-label extension phase. The trial involves single site in the Member State concerned. Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial. Plans for treatment or care after the subject has ended the participation in the trial if it is different from the expected normal treatment of that condition.
Vivir con el VIH