Condition category
Mental and Behavioural Disorders
Date applied
08/06/2005
Date assigned
20/06/2005
Last edited
06/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Firoozeh Raisi

ORCID ID

Contact details

Roozbeh Psychiatric Hospital
Tehran
13185
Iran
+98 21 5412222
Raisi_f@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

110

Study information

Scientific title

Acronym

Depression Project

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Citalopram and nortriptyline

Primary outcome measures

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 trial start date

01/01/2003

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45

Participant 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.

Recruitment start date

01/01/2003

Recruitment end date

01/01/2005

Locations

Countries of recruitment

Iran

Trial participating centre

Roozbeh Psychiatric Hospital
Tehran
13185
Iran

Sponsor information

Organisation

Tehran University of Medical Sciences (Iran)

Sponsor details

Roozbeh Psychiatric Hospital
Tehran University of Medical Sciences
South Kargar Ave.
Tehran
13185
Iran
+98 21 5412222
raisi_f@yahoo.com

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Tehran University of Medical Sciences (Iran) (ref: 110)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes