Trial Outcomes & Findings for Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms (NCT NCT01189812)

Last Updated: 2011-08-24

Results Overview

The S-STS is an 14 item clinician administered prospective rating scale that scores both treatment-emergent suicidal ideations and suicidal behaviors with scores ranging from 0-40 points. Patients scoring a 0 are experiencing no suicidal thoughts, ideations, or attempts, while a score of 40 indicates a fatal, completed suicide. Comparison was made between the citalopram with lithium and the citalopram with placebo treatment groups. Outcome measures are expressed as change scores from the baseline visit to week 4.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

4 weeks; from Baseline to Week 4

Results posted on

2011-08-24

Participant Flow

There were 93 patients screened to meet the enrollment target of 80 randomized subjects into this study. Subjects were recruited from two clinical research centers beginning in March 2010. One site was located in Bellevue, WA, and the other in San Diego, CA. The last patient was screened in December 2010.

After a patients enrolled in the study, the washout period for any excluded concomitant medications was kept to a minimum to avoid potential risk to this severely ill population.

Participant milestones

Participant milestones
Measure	Placebo (Sugar Pill) Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.	Lithium Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
Overall Study STARTED	40	40
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (Sugar Pill) Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.	Lithium Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
Overall Study Withdrawal by Subject	2	3
Overall Study Adverse Event	1	0
Overall Study Out of Window	4	3
Overall Study Moved out of State	1	2

Baseline Characteristics

Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (Sugar Pill) n=40 Participants Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.	Lithium n=40 Participants Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	38.5 years STANDARD_DEVIATION 15.2 • n=5 Participants	45.0 years STANDARD_DEVIATION 11.6 • n=7 Participants	41.8 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	19 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks; from Baseline to Week 4

Population: The ITT population consisted of 80 patients randomized to lithium (n=40)or placebo (n=40).

Outcome measures

Outcome measures
Measure	Placebo (Sugar Pill) n=40 Suicidality scales Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.	Lithium n=40 Suicidality scales Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
Sheehan-Suicidality Tracking Scale (S-STS)	4.8 Scores on a Scale (S-STSS) Standard Deviation 5.5	5.0 Scores on a Scale (S-STSS) Standard Deviation 5.1

SECONDARY outcome

Timeframe: 4 weeks

The BHS measures the extent of negative attitudes about the future. It has particular utility as an indirect indicator of suicidal risk in depressed examinees or individuals who have made suicide attempts. Comparison between citalopram and lithium and citalopram and placebo groups in the BHS will be made from baseline to week 4

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

The BSS is a 21-item slef-report instrument used to detect ans measure the severity of suicidal ideation in adults. It measures a broad spectrum of attitudes and behaviors for assessing patient suicide risk, as well as reveals specific suicidal characteristics which require greater scrutiny. Comparison between citalopram and lithium and citalopram and placebo groups in the BSS will be made from baseline to week 4

Outcome measures

Outcome data not reported

Adverse Events

Placebo (Sugar Pill)

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Lithium

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (Sugar Pill) n=40 participants at risk Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.	Lithium n=40 participants at risk Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
Psychiatric disorders Depression	2.5% 1/40 • Number of events 1 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	0.00% 0/40 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/40 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	2.5% 1/40 • Number of events 1 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.

Other adverse events

Other adverse events
Measure	Placebo (Sugar Pill) n=40 participants at risk Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.	Lithium n=40 participants at risk Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
Nervous system disorders Somnolence	17.5% 7/40 • Number of events 8 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	15.0% 6/40 • Number of events 6 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
Gastrointestinal disorders Nausea	12.5% 5/40 • Number of events 5 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	10.0% 4/40 • Number of events 4 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
Nervous system disorders Headaches	2.5% 1/40 • Number of events 2 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	22.5% 9/40 • Number of events 11 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
Nervous system disorders Dizziness	5.0% 2/40 • Number of events 2 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	5.0% 2/40 • Number of events 2 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
Gastrointestinal disorders Vomiting	2.5% 1/40 • Number of events 1 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	5.0% 2/40 • Number of events 2 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
Nervous system disorders Decreased Appetite	5.0% 2/40 • Number of events 2 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	5.0% 2/40 • Number of events 2 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
Psychiatric disorders Anxiousness	5.0% 2/40 • Number of events 2 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	7.5% 3/40 • Number of events 3 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
Nervous system disorders Restlessness	5.0% 2/40 • Number of events 2 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	0.00% 0/40 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
Infections and infestations Common Cold	5.0% 2/40 • Number of events 2 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	5.0% 2/40 • Number of events 2 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/40 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	7.5% 3/40 • Number of events 3 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
Respiratory, thoracic and mediastinal disorders Upper Respitory Infection	7.5% 3/40 • Number of events 3 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.	0.00% 0/40 • Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.

Additional Information

Director of Clinical Operations

Columbia Northwest Pharmaceuticals

Phone: 425.453.0404

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place