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IRCT20210608051515N2 IRCT 2021-07-18 Tehran University of Medical Sciences Comparison of Venlafaxine and Sertraline Therapeutic Effects on Depression in Patients with Epilepsy Evaluation of the Effectiveness of Antidepressant Agents, Venlafaxine Versus Sertraline in Patients with Epilepsy and Depression 2021-07-21 anticipated 30 Complete https://irct.ir/trial/56779 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in accordance with allocation concealment will be done by generating random codes - consisting of three characters of English letters and numbers - generated using a web resource (here at random.org), then printing the codes on a card, and placing each card in a sealed envelope. (SNOSE method). (The list of these codes will be available only to the investigator who will not intervene in any other part of the study.) Fifteen codes will be generated for intervention group 1 (Venlafaxine) and another fifteen codes for intervention group 2 (Sertraline). These codes are written on the cards to be inserted into the envelopes. Each code is placed in an opaque envelope with an aluminum inner lining; then, the envelope lid will be completely sealed. (All of the above arrangements will be made by the same person who has the list of codes and is responsible for transferring the drugs into the envelope-shaped drug container - in the same shape, color, and containing the same number of tablets for intervention group 1 and 2 - which is used to deliver the drug to patients). Sealed envelopes containing coded cards will be shuffled; each will be numbered from 1 to 30 and placed in a box handed over to another researcher responsible for delivering the drugs to the participants. Finally, the patients who will be referred to the order will be given a numbered envelope out of the box; the envelope seal will be is broken, the drug number 1 or 2 envelope-like container (anonymous for both the researcher and the patient) will be delivered to the patient according to the code on the card, his details are written on the envelope also in a separate list. In that list, each patients' name will be written in front of their envelope code. Thus, in subsequent visits (weeks 3, 8, and 16), while assessing clinical changes, the delivery of paper envelope-like containers including the first or second intervention drug (venlafaxine or sertraline) is done based on the patient's code. The researcher delivers drugs to the patients, and the patient does not know the type of intervention. (It is emphasized that the production of codes and the allocation of half of the codes to intervention 1 and the other half to intervention 2 is done by another researcher who has no responsibility in this or other stages of the study), Blinding description: Study participants will all be unaware of the group they will be allocated to (intervention 1 or intervention 2). However, they are aware that they will participate in a study that they will be given either venlafaxine or sertraline. Also, due to the coded label and the same specifications on the envelope containing drugs 1 and 2, blinding is done as much as possible. However, because the two drugs used in the study will not be the same in terms of color, odor, shape, and size (due to the impossibility of this task to us), blinding will not be completely feasible. Clinical caregivers, researchers, and physicians responsible for diagnosis and treatment will all be unaware of the treatment assigned to the person being examined. Those responsible for evaluating the results will also evaluate and analyze the statistical analysis of the data through coding done for patients, without knowing the patient group - Drug 1 or Drug 2. The Data Safety and Monitoring Committee also monitors the identities of people who have received the drug or placebo and their identities and only monitors the above in accordance with blinding, concealment, and data collection protocols. 2-3 Condition 1: Depressive Disorders. Condition 2: Epilepsy. Intervention 1: Intervention group 1: venlafaxine; Drug therapy started with 37.5 mg in the first week, reached 75 mg in the second week and finally reached 150 mg in the third week to the sixteenth week. Intervention 2: Intervention group 2: Sertraline; Drug therapy in this group starts with 25 mg in the first week, reaches 50 mg in the second week, and is finally 100 mg in the third week to the sixteenth week. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available.
public Seyyed Reza Ebadi
No. 7, 3rd Block, Maahtaab Ave., Aftaab Ave., Khodammi Ave., Vanak.,
Tehran Iran (Islamic Republic of) 1994964811 +98 21 8821 2409 seyyedrezae@gmail.com Tehran University of Medical Sciences scientific Abbas Tafakhori
Qadr Ave., North Karegar Ave., Enqelab Sq., Tehran, Tehran
Tehran Iran (Islamic Republic of) 1415983111 +98 21 6687 9867 abbas.tafakhori@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Definite Diagnosis of Epilepsy based on Clinical Findings and Neurologist View Positive Evaluation of Depression based on NDDI-E Questionnaire Clinical Diagnosis of Moderate to Severe Depression Using Hamilton Depression Scale 18 years 75 years Both Suicide Attempt in Recent Year Alcohol or Substance Abuse History of a Complex Mood Disorder e.g. Bipolar Disorder Other Accompanying Neurological Disease Evidence of Hypersensitivity to SSRIs Hypertension Major Kidney or Liver Dysfunction Active Hemorrhage Pregnancy and Breast-feeding F06.31 G40 Mood disorder due to known physiological condition with depressive features Epilepsy and recurrent seizures Treatment - Drugs Treatment - Drugs Intervention group 1: venlafaxine; Drug therapy started with 37.5 mg in the first week, reached 75 mg in the second week and finally reached 150 mg in the third week to the sixteenth week. Intervention group 2: Sertraline; Drug therapy in this group starts with 25 mg in the first week, reaches 50 mg in the second week, and is finally 100 mg in the third week to the sixteenth week. The severity of depression in patients with epilepsy participating in the study according to the Hamilton scale. Timepoint: Depression severity at the beginning of the study (before the intervention), the third, eighth, and sixteenth weeks after the intervention is evaluated. Method of measurement: Hamilton depression clinical scale (HAM-D). Number of seizures that occur during the week (if any). Timepoint: At the beginning of the study (before the intervention) and then the third, eighth, and sixteenth week after the intervention. Method of measurement: Counting the number of seizures per week based on history. Quality of Life in Epilepsy. Timepoint: Before initiating the therapy and after sixteen week of treatment. Method of measurement: Quality of Life in Epilepsy (31 Questions) Questionnaire. Pharmacological side effects. Timepoint: In the first week and then the third and eighth after the intervention. Method of measurement: Based on the history and a prepared form of drug side effects. Tehran University of Medical Sciences Approved 2021-06-13 Ethics Committee of Tehran University of Medical Sciences, Room 605، Secretariat of the Ethics Committee in University Biomedical Research، Vice Chancellor for Research and Technology, 6th Floor, Central University Organization, Corner of Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)