Assessment of additive effects of crocin in men with depression induced by amphetamine withdrawal

Additive effects of crocin on depression symptoms in men with moderate depression induced by amphetamine withdrawal admitted to Ibn-e-Sina Hospital, Mashhad

A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial Triple masking (Participant, Investigator, Outcomes Assessor and Statistician)

Patients referred to Ibn-e-sina hospital- Mashhad- Iran, after signing informed consent, will be randomly allocated to the following two groups. Placebo Group in which, patients (n=30) will receive placebo tablets and Crocin Group in which, patients (n=30) will receive Crocin 15 mg, daily, for 12 weeks. All subjects will receive the conventional depression therapy during study.

Inclusion criteria: (1) Men with moderate depression induced by amphetamine withdrawal, (2) Being 20-50 years old, (3) Patient consent to participate in the study, (4) Not having specific physical (e.g. cancer, Acquired immunodeficiency syndrome (AIDS), Multiple Sclerosis (MS)) or mental illness, (5) Not having allergic to saffron/crocin Exclusion criteria: Lack of patient cooperation in Crocin consumption Having allergic reaction or intolerable side effect caused by crocin

Placebo Group in which, patients (n=30) will receive placebo tablets and Crocin Group in which, patients (n=30) will receive Crocin 15 mg daily for 12 weeks.

Beck Depression Inventory (BDI) questionnaire and General Health Questionnaire (GHQ) will be completed before treatment (day 0) and at the end of weeks 4, 8 and 12 after starting treatment.

Simple randomization method (using https://www.Randomization.com-generated sequence). In this method, using website https://www.Randomization.com that generates the random number sequences, the random number sequences are determined for the required sample size (n=30 in each group). Following, after patients enter the study based on the inclusion criteria, according to the list of the random number sequences generated, individuals are assigned to one of the intervention and placebo groups, and this continues until the number of patients in each group is completed.

Drugs will be packed and labelled . No information on the randomization schedule or the contents of drug packs will be available to patients, investigators, care providers and outcomes assessors and they will be blinded. The patients will be blinded in the sense that they do not know whether they were receiving the placebo or crocin. They randomly assign to one of the two groups. The investigators doing the interventions will be blinded as to the contents of the drug using drugs labelling. Also care providers and outcomes assessors shall be blinded as to what group the patient belongs to. One person in the project who does not belong to any of the groups of patients, investigators, care providers and outcomes assessors, will oversee on blinding method.

Dr. Vahideh Ghorani is committed to presenting all the achievements of the project in accordance with the framework of Mashhad University of Medical Sciences.