Combination of citalopram and nortriptyline in the treatment of moderate to severe major depression: a double-blind placebo-controlled trial
| ISRCTN | ISRCTN13406737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13406737 |
| Secondary identifying numbers | 110 |
- Submission date
- 08/06/2005
- Registration date
- 20/06/2005
- Last edited
- 06/11/2009
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Firoozeh Raisi
Scientific
Scientific
Roozbeh Psychiatric Hospital
Tehran
13185
Iran
| Phone | +98 21 5412222 |
|---|---|
| Raisi_f@yahoo.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Depression Project |
| Study objectives | Depression is one of the most common psychiatric disorders, which can be categorized as mild to severe. Combination therapy may rapidly reduce depressive symptoms in patients with moderate to severe depression and is more effective than monotherapy, but it is controversial. In fact, serotonergic and noradrenergic enhancement may be synergistic and more effective than serotonergic enhancement alone in treating depression. The object of this double-blind study was to compare the efficacy and safety of selective serotonin reuptake inhibitor (SSRI)-tricyclic antidepressant (TCA) combination with SSRI alone in patients with moderate to severe depression. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | All patients gave a complete medical and psychiatric history and were given a physical examination before entry into the study. Then 19 subjects were assigned in a random fashion to nortriptyline 50 mg/day plus citalopram 40 mg/day (group 1) and 19 subjects to placebo plus citalopram 40 mg/day (group 2) for an 8 week, double-blind, placebo-controlled study. The dosage of citalopram (in both groups) was titrated up to 40 mg/day over three days and the dosage of nortriptyline (in group 1) was titrated up to 50 mg/day over three days. Patients didn't receive other psychopharmacological drugs during the trial and they were not permitted to have psychotherapy. At each scheduled visit, patients were assessed by a resident of psychiatry, using a standardized protocol for the HAM-D at baseline and after 2, 4, 6 and 8 weeks after medication was started. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Citalopram and nortriptyline |
| Primary outcome measure | The principal measure of the outcome was the 17-item HAM-D. The mean decrease in HAM-D score from baseline was used as the main outcome measure of response of depression to treatment. |
| Secondary outcome measures | Side-effects were systematically recorded throughout the study and were assessed using a checklist administered by a resident of psychiatry on week 2, 4, 6 and 8. |
| Overall study start date | 01/01/2003 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 45 |
| Key inclusion criteria | After giving informed consent and discontinuing all psychotropic medications for 2 weeks, 45 outpatients (28 female and 17 male) between 18 and 54 years of age were enrolled in the study. Seven subjects dropped out after the first week of treatment due to noncompliance (3 subjects from group 1 and 4 subjects from group 2) leaving 38 patients (24 female and 14 male) who completed the trial. All subjects met the Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria for major depressive disorder (MDD), based on the structured clinical interview for DSM-IV and had a baseline Hamilton Rating scale for depression (HAM-D, 17 item) score of at least 20. The HAM-D is, the most widely used physician-administrated rating scale for depression, summates 17 individual item scores to provide a total score indicative of the severity of depression. |
| Key exclusion criteria | Patients with a history of other psychiatric disorders, history of bipolar disorder, personality disorder, anxiety disorder, substance abuse, alcoholism, and organic brain disorders were excluded. Also patients were excluded if they were psychotic or posed a significant risk of suicide at any time during participation. Pregnant or lactating women were excluded. All patients were free of unstable medical disorders including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or hematological illnesses. |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- Iran
Study participating centre
Roozbeh Psychiatric Hospital
Tehran
13185
Iran
13185
Iran
Sponsor information
Tehran University of Medical Sciences (Iran)
University/education
University/education
Roozbeh Psychiatric Hospital
Tehran University of Medical Sciences
South Kargar Ave.
Tehran
13185
Iran
| Phone | +98 21 5412222 |
|---|---|
| raisi_f@yahoo.com | |
"ROR" |
https://ror.org/01c4pz451 |
Funders
Funder type
University/education
Tehran University of Medical Sciences (Iran) (ref: 110)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
