Major DepressionPhase 4NCT00177996
Pharmacotherapy in Depression With Panic Spectrum
A Phase 4 study testing sertraline hydrochloride in people with Major Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
This research study is being conducted to find out if certain individuals benefit from taking medication for their depression with a low dose of the antidepressant medication Zoloft. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depression
- What is being tested?
- sertraline hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female ages 18-60;
- Current diagnosis of major depression, and a rating of ³15 on the HRS-D-25; - -Presence of significant, co-existing panic-agoraphobic spectrum symptoms,
- Absence of ongoing therapy with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications
- Physically healthy,
- Female participants of childbearing potential must be practicing a medically acceptable form of double-barrier birth control or using oral contraceptives such as birth control pills, implants, or injections;
Who cannot join
- Females who are pregnant or breast-feeding;
- History of suicide attempt in the 6 months prior to entry, active suicidal ideation, or significant suicide risk;
- History of hypersensitivity to or current use of sertraline;
- Unstable or untreated medical conditions,
- Participants who do not wish to discontinue current, ineffective antidepressant treatment;
- Participants who have recently begun psychotherapy (less than 3 months prior to study entry);
- Diagnosis of current panic disorder, psychosis, substance or alcohol abuse, anorexia, bulimia, dissociative, bipolar disorder, or any other psychiatric or medical illness that would interfere with the best treatment strategy for the potential participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Insititue and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
This research study is being conducted to find out if certain individuals benefit from taking medication for their depression with a low dose of the antidepressant medication Zoloft.
Read the detailed description
Researchers at the University of Pittsburgh Medical Center Health System are currently recruiting men and women, ages 18 to 60, to examine the effectiveness of the FDA-approved medication sertraline (Zoloft) for major depression.
Participants will be randomly assigned to one of two groups. Each group will begin and continue taking Zoloft at different doses. A physician will follow eligible participants weekly for approximately 12 weeks
- Conditions
- Major Depression
- Being tested
- sertraline hydrochloride
- Keywords
- depression, anxiety
- Medical subject headings
- Depressive Disorder, Major, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertraline hydrochlorideDrug
Also called sertraline hydrochloride low versus high dose titration
The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of sertraline. The doses and titration schedules used in this study are consistent with recommended FDA guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Sertaline high dose titration | Active comparator | The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of Sertraline hydrochloride. The doses and titration schedules used in this arm (Sertaline high dose titration) are consistent with recommended FDA guidelines. Receives: Drug: sertraline hydrochloride |
| Sertaline low dose titration | Active comparator | The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of Sertraline hydrochloride. The doses and titration schedules used in this arm (Sertaline low dose titration) are consistent with recommended FDA guidelines. Receives: Drug: sertraline hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatic Symptoms Scale (SSC)
Scale to evaluate somatic and panic like symptoms
Measured: 1 week
Secondary outcomes (2)
Hamilton Rating Scale For Depression- 25 item (HRSD 25)
scale to evaluate depressive symptoms
Measured: 1 week
Global Assessment of Functioning (GAF)
scale to evaluate ability to function
Measured: past week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2001
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Fagiolini, University of Pittsburgh
- Investigators
- Andrea Fagiolini, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177996
- Sponsor's protocol ID
- 010403
- Status last verified
- Jan 2016
- First submitted
- 13 Sep 2005
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacotherapy in Depression With Panic Spectrum
- ClinicalTrials.gov ID
- NCT00177996
- Acronym / sponsor ID
- 010403
- Conditions
- Major Depression
- Keywords
- depression, anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2001
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being conducted to find out if certain individuals benefit from taking medication for their depression with a low dose of the antidepressant medication Zoloft.
Detailed description
Researchers at the University of Pittsburgh Medical Center Health System are currently recruiting men and women, ages 18 to 60, to examine the effectiveness of the FDA-approved medication sertraline (Zoloft) for major depression.
Participants will be randomly assigned to one of two groups. Each group will begin and continue taking Zoloft at different doses. A physician will follow eligible participants weekly for approximately 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertaline high dose titration | Active comparator | Drug: sertraline hydrochlorideThe study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of Sertraline hydrochloride. The doses and titration schedules used in this arm (Sertaline high dose titration) are consistent with recommended FDA guidelines. |
| Sertaline low dose titration | Active comparator | Drug: sertraline hydrochlorideThe study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of Sertraline hydrochloride. The doses and titration schedules used in this arm (Sertaline low dose titration) are consistent with recommended FDA guidelines. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female ages 18-60;
- Current diagnosis of major depression, and a rating of ³15 on the HRS-D-25; - -Presence of significant, co-existing panic-agoraphobic spectrum symptoms,
- Absence of ongoing therapy with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications
- Physically healthy,
- Female participants of childbearing potential must be practicing a medically acceptable form of double-barrier birth control or using oral contraceptives such as birth control pills, implants, or injections;
Key exclusion criteria (7 listed)
- Females who are pregnant or breast-feeding;
- History of suicide attempt in the 6 months prior to entry, active suicidal ideation, or significant suicide risk;
- History of hypersensitivity to or current use of sertraline;
- Unstable or untreated medical conditions,
- Participants who do not wish to discontinue current, ineffective antidepressant treatment;
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 |
|---|---|---|
| sertraline hydrochlorideAlso: sertraline hydrochloride low versus high dose titrationThe study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of sertraline. The doses and titration schedules used in this study are consistent with recommended FDA guidelines. | Drug | Sertaline high dose titration, Sertaline low dose titration |
Primary outcome
Somatic Symptoms Scale (SSC)
Time frame: 1 week
Scale to evaluate somatic and panic like symptoms
2 secondary outcomes
Hamilton Rating Scale For Depression- 25 item (HRSD 25)
Time frame: 1 week
Global Assessment of Functioning (GAF)
Time frame: past week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Individual participant dataSharing planned: Undecided
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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.
Andrea Fagiolini, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sertraline hydrochloride in people with Major Depression, run by University of Pittsburgh at 1 site 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 5 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 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Somatic Symptoms Scale (SSC) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2016.