DepressionPhase 4NCT00073697
Treatment of Depression in Adults
A Phase 4 study testing Escitalopram, Interpersonal Psychotherapy and Escitalopram plus IPT in people with Depression, run by University of Pittsburgh at 2 sites in 2 countries.
Trial summary
This study will determine how certain features of depressed individuals affect their responses to depression treatment. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram, Interpersonal Psychotherapy and Escitalopram plus IPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2003to Oct 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 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Major depression
Who cannot join
- History of manic or hypomanic episodes
- History of schizophrenia or schizoaffective disorder
- Diagnosis of anorexia nervosa or bulimia nervosa
- Current psychosis
- Drug and/or alcohol dependence or abuse within 3 months prior to study entry. Participants with episodic abuse related to mood disorders will not be excluded.
- Diagnosis of antisocial personality disorder
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- Diagnosis of organic affective syndrome and uncontrolled medical illness
- Pregnancy
- Require inpatient treatment for suicidal risk or psychosis
- History of an inability to tolerate any of the study treatments
- Currently receiving treatment with an effective antidepressant
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Western Psychiatric Institute and Clinic - Depression Prevention Program
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Depression: The Search for Treatment-Relevant Phenotypes
This study will determine how certain features of depressed individuals affect their responses to depression treatment.
Read the detailed description
Major depression is a serious condition that can have devastating functional consequences. Although numerous depression studies have been conducted, understanding of how best to achieve long-term recovery remains limited. This study will assess the mood, personality, pharamcokinetic and genetic characteristics of depressed participants to determine the effects of these features on treatment response.
This study will be conducted at two international treatment sites, including the University of Pittsburgh and the University of Pisa, Italy. Participants will be randomly assigned to receive either interpersonal psychotherapy (IPT) or escitalopram pharmacotherapy for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months; those who do not will have the second treatment added to their regimen until remission occurs. Clinical evaluations and questionnaires will be used to assess participants.
- Conditions
- Depression
- Being tested
- Escitalopram, Interpersonal Psychotherapy, Escitalopram plus IPT
- Keywords
- Psychotherapy, Depressive disorder, Antidepressive agents, Citalopram
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Participants will receive escitalopram for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months.
Interpersonal PsychotherapyBehavioural
Participants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months.
Escitalopram plus IPTOther
Participants whose symptoms become stabilized will continue the initial treatment for another 6 months. Those who do not will have the second treatment added to their regimen until remission occurs.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Interpersonal Psychotherapy Receives: Behavioral: Interpersonal Psychotherapy |
| 2 | Experimental | Escitalopram Receives: Drug: Escitalopram |
| 3 | Experimental | Escitalopram plus IPT Receives: Other: Escitalopram plus IPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression score
Measured: Measured at Months 8 and 14
Treatment-relevant phenotypes of depression
Measured: Measured at Months 8 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2003 (estimated)
- Study startMay 2003
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Ellen Frank, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073697
- Sponsor's protocol ID
- R01MH065376
- Other IDs
- R01MH065376, DSIR 83-ATAS
- Status last verified
- Jan 2012
- First submitted
- 2 Dec 2003
- Last updated
- 11 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression: The Search for Treatment-Relevant Phenotypes
- ClinicalTrials.gov ID
- NCT00073697
- Acronym / sponsor ID
- R01MH065376
- Conditions
- Depression
- Keywords
- Psychotherapy, Depressive disorder, Antidepressive agents, Citalopram
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 3 Dec 2003 (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 study will determine how certain features of depressed individuals affect their responses to depression treatment.
Detailed description
Major depression is a serious condition that can have devastating functional consequences. Although numerous depression studies have been conducted, understanding of how best to achieve long-term recovery remains limited. This study will assess the mood, personality, pharamcokinetic and genetic characteristics of depressed participants to determine the effects of these features on treatment response.
This study will be conducted at two international treatment sites, including the University of Pittsburgh and the University of Pisa, Italy. Participants will be randomly assigned to receive either interpersonal psychotherapy (IPT) or escitalopram pharmacotherapy for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months; those who do not will have the second treatment added to their regimen until remission occurs. Clinical evaluations and questionnaires will be used to assess participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Interpersonal PsychotherapyInterpersonal Psychotherapy |
| 2 | Experimental | Drug: EscitalopramEscitalopram |
| 3 | Experimental | Other: Escitalopram plus IPTEscitalopram plus IPT |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Major depression
Key exclusion criteria (11 listed)
- History of manic or hypomanic episodes
- History of schizophrenia or schizoaffective disorder
- Diagnosis of anorexia nervosa or bulimia nervosa
- Current psychosis
- Drug and/or alcohol dependence or abuse within 3 months prior to study entry. Participants with episodic abuse related to mood disorders will not be excluded.
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 |
|---|---|---|
| EscitalopramParticipants will receive escitalopram for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months. | Drug | 2 |
| Interpersonal PsychotherapyParticipants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months. | Behavioural | 1 |
| Escitalopram plus IPTParticipants whose symptoms become stabilized will continue the initial treatment for another 6 months. Those who do not will have the second treatment added to their regimen until remission occurs. | Other | 3 |
Primary outcome
Hamilton Rating Scale for Depression score
Time frame: Measured at Months 8 and 14
Treatment-relevant phenotypes of depression
Time frame: Measured at Months 8 and 14
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 11 Jan 2012.
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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.
Ellen Frank principal investigator
University of Pittsburgh
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram, Interpersonal Psychotherapy and Escitalopram plus IPT in people with Depression, run by University of Pittsburgh at 2 sites in 2 countries.
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 1 inclusion and 11 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 11 Jan 2012. 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, Italy. 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?
Hamilton Rating Scale for Depression score (time frame: Measured at Months 8 and 14). The study lists 2 primary outcomes in all. 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 11 Jan 2012.