Major Depressive DisorderPhase 2NCT01189812

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

A Phase 2 study testing Lithium Carbonate and Citalopram in people with Major Depressive Disorder and Dysthymia, run by Columbia Northwest Pharmaceuticals at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The investigators hypothesize that patients receiving citalopram in combination with lithium will have a greater reduction in depressive symptoms than patients receiving citalopram in combination with placebo. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified
What is being tested?: Lithium Carbonate and Citalopram
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 2 sitesUnited States
Study dates: Mar 2010to Jan 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18-75 years of age
Meets criteria for Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified or Borderline Personality Disorder
Ability to speak, read and understand the English Language and provide written informed consent

Who cannot join

Current, unstable and significant medical condition or illness
History of Thyroid disorder, seizure disorder, tumors or other CNS condition that predisposes the patient to risk of seizure
Pregnant or lactating females
Abnormal clinical laboratory test results
Intolerance or hypersensitivity to SSRIs or lithium
History or current diagnosis of bipolar mood disorder, psychosis, schizophrenia or dementia
Certain mediations my not be used prior or during the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Northwest Clinical Research Center
Bellevue, Washington, 98007
Artemis Institute for Clinical Research
San Diego, California, 92123

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Assess the Safety and Efficacy of Citalopram in Combination With Lithium or Placebo in the Treatment of Symptoms in Patients With Depressive Mood Disorders

Conditions: Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified, Borderline Personality Disorder
Being tested: Lithium Carbonate, Placebo, Citalopram
Keywords: hopelessness, alone, sad, troubled, depression
Medical subject headings: Depressive Disorder, Major, Dysthymic Disorder, Borderline Personality Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lithium CarbonateDrug
300 mg one time per day for 4 weeks
PlaceboDrug
Take one time daily for 4 weeks
CitalopramDrug
Also called Celexa
All patients will be administered Citalopram 20 mg to to be taken once daily, by mouth for the duration of the double-blind treatment phase (4 weeks)

Study groups in NCT01189812
Study group	Role	What they receive
sugar pill	Placebo comparator	Not described Receives: Drug: Placebo; Drug: Citalopram
Lithium	Active comparator	Not described Receives: Drug: Lithium Carbonate; Drug: Citalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

Sheehan-Suicidality Tracking Scale (S-STS)
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.
Measured: 4 weeks; from Baseline to Week 4

Secondary outcomes (2)

Beck Hopelessness Scale (BHS)
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
Measured: 4 weeks
Beck Scale for Suicide Ideation (BSS)
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
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Jan 2011

First posted27 Aug 2010 (estimated)
Study startMar 2010
Primary completionJan 2011
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01189812
Sponsor's protocol ID: LP-DP-09201
Status last verified: Aug 2011
First submitted: 18 Mar 2010
Last updated: 24 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Assess the Safety and Efficacy of Citalopram in Combination With Lithium or Placebo in the Treatment of Symptoms in Patients With Depressive Mood Disorders
ClinicalTrials.gov ID: NCT01189812
Acronym / sponsor ID: LP-DP-09201
Conditions: Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified, Borderline Personality Disorder
Keywords: hopelessness, alone, sad, troubled, depression
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Columbia Northwest PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 27 Aug 2010 (estimated)
Results: Posted 8 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
sugar pill	Placebo comparator	Drug: Placebo, Drug: Citalopram
Lithium	Active comparator	Drug: Lithium Carbonate, Drug: Citalopram

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18-75 years of age
Meets criteria for Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified or Borderline Personality Disorder
Ability to speak, read and understand the English Language and provide written informed consent

Key exclusion criteria (7 listed)

Current, unstable and significant medical condition or illness
History of Thyroid disorder, seizure disorder, tumors or other CNS condition that predisposes the patient to risk of seizure
Pregnant or lactating females
Abnormal clinical laboratory test results
Intolerance or hypersensitivity to SSRIs or lithium

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lithium Carbonate300 mg one time per day for 4 weeks	Drug	Lithium
PlaceboTake one time daily for 4 weeks	Drug	sugar pill
CitalopramAlso: CelexaAll patients will be administered Citalopram 20 mg to to be taken once daily, by mouth for the duration of the double-blind treatment phase (4 weeks)	Drug	Lithium, sugar pill

Primary outcome

Sheehan-Suicidality Tracking Scale (S-STS)
Time frame: 4 weeks; from Baseline to Week 4
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.

2 secondary outcomes

Beck Hopelessness Scale (BHS)
Time frame: 4 weeks
Beck Scale for Suicide Ideation (BSS)
Time frame: 4 weeks

Results and safety

Results posted to the registry on 8 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Sugar Pill)	40	32
Lithium	40	32

Primary outcome: Sheehan-Suicidality Tracking Scale (S-STS)

Time frame: 4 weeks; from Baseline to Week 4. Mean (Standard Deviation). Unit: Scores on a Scale (S-STSS)

Measure	Placebo (Sugar Pill) n = 40	Lithium n = 40
Value	4.8 (5.5)	5.0 (5.1)

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

2 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Sugar Pill)	1 of 40 (2.5%)	18 of 40 (45%)	Not reported
Lithium	1 of 40 (2.5%)	21 of 40 (52.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arifulla Khan, MD principal investigator

Northwest Clinical Research Center

Vishaal Mehra, MD principal investigator

Aretmis Institute for Clinical Research

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lithium Carbonate and Citalopram in people with Major Depressive Disorder and Dysthymia, run by Columbia Northwest Pharmaceuticals at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sheehan-Suicidality Tracking Scale (S-STS) (time frame: 4 weeks; from Baseline to Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01189812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2011.