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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Columbia Northwest Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01189812

First received: March 18, 2010

Last updated: August 22, 2011

Last verified: August 2011

History of Changes

Results First Received: March 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Major Depressive Disorder Dysthymia Depression Not Otherwise Specified Borderline Personality Disorder
Interventions:	Drug: Lithium Carbonate Drug: Placebo Drug: Citalopram

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Placebo (Sugar Pill)	Lithium
STARTED	40	40
COMPLETED	32	32
NOT COMPLETED	8	8
Withdrawal by Subject	2	3
Adverse Event	1	0
Out of Window	4	3
Moved out of State	1	2

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Placebo (Sugar Pill)	Lithium	Total
Number of Participants [units: participants]	40	40	80
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	39	39	78
>=65 years	1	1	2
Age [units: years] Mean ± Standard Deviation	38.5 ± 15.2	45.0 ± 11.6	41.8 ± 13.8
Gender [units: participants]
Female	25	19	44
Male	15	21	36
Region of Enrollment [units: participants]
United States	40	40	80

Outcome Measures

1. Primary:

Sheehan-Suicidality Tracking Scale (S-STS) [ Time Frame: 4 weeks; from Baseline to Week 4 ]

Show Outcome Measure 1

2. Secondary:

Beck Hopelessness Scale (BHS) [ Time Frame: 4 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Beck Scale for Suicide Ideation (BSS) [ Time Frame: 4 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

Hide Serious Adverse Events

Time Frame	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 Description	No text entered.

Reporting Groups

	Description
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.

Serious Adverse Events

	Placebo (Sugar Pill)	Lithium
Total, serious adverse events
# participants affected / at risk	1/40 (2.50%)	1/40 (2.50%)
Psychiatric disorders
Depression ^{* 1 [3]}
# participants affected / at risk	1/40 (2.50%)	0/40 (0.00%)
# events	1	0
Skin and subcutaneous tissue disorders
Psoriasis ^{* 1 [4]}
# participants affected / at risk	0/40 (0.00%)	1/40 (2.50%)
# events	0	1

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (11.1)
[3]	Patient reported that hospitalization post trial participation for worsening depression symptoms.
[4]	Patient was hospitalized for worsening psoriasis during the screening period of the trial.

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Director of Clinical Operations
Organization: Columbia Northwest Pharmaceuticals
phone: 425.453.0404
e-mail: jhobus@nwcrc.net

No publications provided

Responsible Party:	Columbia Northwest Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01189812 History of Changes
Other Study ID Numbers:	LP-DP-09201
Study First Received:	March 18, 2010
Results First Received:	March 28, 2011
Last Updated:	August 22, 2011
Health Authority:	United States: Food and Drug Administration

To Top