Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: a pilot double-blind randomised trial
| ISRCTN | ISRCTN45683816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45683816 |
| Protocol serial number | 555 |
| Sponsor | Roozbeh Psychiatric Hospital (Iran) |
| Funder | Tehran University of Medical Sciences (Iran) |
- Submission date
- 26/08/2004
- Registration date
- 31/08/2004
- Last edited
- 09/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Shahin Akhondzadeh
Scientific
Scientific
Roozbeh Psychiatric Hospital
Tehran
13337
Iran
| Phone | +98 21 5412222 |
|---|---|
| sakhond@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Saffron Project |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Major depression |
| Intervention | In this double-blind, single-centre trial, patients were randomly assigned to receive capsule of saffron 30 mg/day (10 mg three times a day [TDS]) (Group 1) and capsule of imipramine 100 mg/day (33.3 mg TDS) (Group 2) for a 6-week study. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Crocus sativus L., imipramine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) for major depression based on the structured clinical interview for DSM IV participated in the trial 2. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/02/2004 |
Locations
Countries of recruitment
- Iran
Study participating centre
Roozbeh Psychiatric Hospital
Tehran
13337
Iran
13337
Iran
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 02/09/2004 | Yes | No |
