Comparing the Effect of Sodium valproate with Lithium carbonate on Suicidal Ideation of Patients with Bipolar Disorder in Manic Phase with Mediation of Interoception

Investigation and Comparison of the Effects of Lithium and Valproate on Bodily Awareness in Bipolar Patients During the Manic Phase and the Relationship with Suicidal Thoughts in Bipolar Patients During the Manic Phase

Clinical Trial with Control Group, with Parallel Groups, Double-Blind, Randomized according to the Block Method, Phase 2 on 40 Patients. the Website: www.randomization.com is used for randomization.

Patients Admitted to the emergency department of Ibn-e- Sina Psychiatric Hospital in Mashhad after the Initial Diagnosis Based on Bipolar Disorder in the Mania Phase are considered (by the Psychiatry Resident on Duty).After Confirming the Diagnosis by the psychiatrist, after completing the informed consent form the Patient's Legal Guardian, the Patient is given the questionnaires mentioned above, and according to the Block Randomization Method, the Patients are divided into Two Groups Using Sodium valproate (with a Dose of 20 mg per Kilogram of Body Weight) and Lithium carbonate (to create Blood Level of 0.9 to 1.2 Mili equivalents) are divided by a Psychiatrist that the Psychiatry Resident and Analyser are not Aware. After 2, 4, 6 and 8 Weeks of Hospitalization, the Questionnaires will be repeated.

Patients Aged 18 to 60 years with Bipolar 1 Disorder in the First Acute Manic Episode

Intervention Group: Patients Using Lithium carbonate Medication Control Group: Patients Using Sodium valproate Medication In both Groups in the Beginning of Admission and after 2, 4, 6 and 8 Weeks of Admission the Three Questionnaires of Beck's Suicidal Thoughts, Young Mania Scale and Body Awareness are filled by the Patients.

Effect of Sodium valproate and Lithium on Interoception and Suicidal Idea of Bipolar Patients

Block Randomization Method will be used to generate a Sequence of Random Numbers. In this Method, 5 Blocks of Size 4 and 10 Blocks of Size 2 will be randomly selected from Combinations of Letters A and B with a Table of Random Numbers. The List of Blocks with Size 2 Includes: 1: AB and 2: BA. The List of Blocks with Size 4 includes: 1: ABBA, 2: AABB, 3: BBAA, 4: BAAB, 5: BABA and 6: ABAB. To Select Blocks of Size 2, 10 Numbers will be randomly chosen from the Table of Random Numbers, then if the Number is between 0 and 4, the First Block will be chosen; and if the Number is between 5 and 9, the Second Block will be chosen. For Selecting Blocks of Size 4, 5 Numbers between 1 and 6 will be randomly chosen from the Table of Random Numbers. Then, if the chosen number is 1, the First Block of Size 4 will be selected; if the chosen Number is 2, the Second Block will be selected, and so on for the rest of the Blocks. The Table of Random Numbers is available Using this site: www.randomization.com. The Generated Allocation Sequence will be placed in Sealed Envelopes and will be revealed to Participants upon their Entry into the Study.

In this study, the Psychiatric Resident who is in Charge of Conducting the Psychological Tests does not know about the Medication taken by the Patients, and the Hospitalized Patients are visited by a separate Psychiatrist. Also, the Data Analyst has no Information about the Medication taken by the Patients.

Participant Data file: except the demographic characteristics of the Patients, other Data can be shared. The Study Protocol can be shared. The Map of Statistical Analysis can be shared as a Summary.

The access period starts 1 year after the results are published.

Researchers working in Academic and Scientific Institutions

A detailed explanation of the reason for the data request by the person in question and the acceptance of this issue by all the people responsible for this study

Through the E-mail: kianas.72@gmail.com refer to Kiana Sedighi

First, his/her email is read and evaluated by the responsible person. After that, other people responsible for this study will be informed, and if all people agree, after approximately 1 month, the answer to the applicant's email will be given in the form of sending a scan of the documents.