Evaluation of the Effectiveness of Antidepressant Agents, Venlafaxine Versus Sertraline in Patients with Epilepsy and Depression

Comparing therapeutic effects of venlafaxine and sertraline on depressive symptoms, the number of seizures, and quality of life in patients with epilepsy

Two arm parallel group, concealed, randomized clinical trial. Each parallel group includes 15 patients with epilepsy and associated depression. rand function will be used on excel for randomization. It is a phase 2 trial.

A hospital clinic has been chosen for the selection, treatment allocation of patients, and before and after evaluation procedures. These steps will be conducted using a screening questionnaire, clinical interview based on the Hamilton depression scale, and allocation to one of the two parallel treatment groups.

18 to 75 years old patients with a definite diagnosis of epilepsy by a certified neurologist who acquire the clinical diagnostic criteria of depression based on the NDDI-E questionnaire and Hamilton depression clinical scale

This study has two intervention groups (1 and 2), including patients with epilepsy and in whom the symptoms of depression have been evaluated. Group 1 will be given venlafaxine at a specific dose and gradually increasing the dose to 37.5, 75, and 150 ml for the first, second, and subsequent weeks, respectively. Group 2 will also be given sertraline at a specific dose and gradually increasing the dose to 25, 50, and 100 ml for the first, second, and subsequent weeks, respectively

Evaluation of changes in signs and symptoms of depression associated with epilepsy; Changes in the number of seizures following possible control of depression; Evaluation of changes in quality of life with the possible reduction of depressive symptoms following the effectiveness of drug treatment

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)

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.