DepressionPhase 4NCT00227955
Comparing Various Treatments for Achieving and Maintaining Remission of Depression
A Phase 4 study testing Imipramine and Interpersonal Psychotherapy in people with Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of five combinations of drug therapy and psychotherapy in maintaining remission of depression symptoms in people with recurrent major depression. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Imipramine and Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1987to Dec 1993
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of recurrent major depression
Who cannot join
- Unstable medical illness
- Any other simultaneous psychiatric or medical illness of greater concern than depression (index episode of depression is not primary)
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Cinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Maintenance Therapies in Recurrent Depression-Study I
This study will evaluate the effectiveness of five combinations of drug therapy and psychotherapy in maintaining remission of depression symptoms in people with recurrent major depression.
Read the detailed description
Depression is a serious illness that can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that once were pleasurable. It is characterized by several symptoms, such as the following: persistent sad, anxious, or "empty" mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. If left untreated, depression symptoms can last for years, and may worsen as time goes on. Even with treatment, however, it is possible for depression to recur. Remission is a main goal in the treatment of depression and it may be accomplished through various strategies. This study will evaluate the effectiveness of five combinations of treatments, including medication therapy and psychotherapy, in maintaining remission of depression symptoms.
All participants in this study will first be treated with imipramine for 7 to 11 months. Once remission of depression symptoms has been achieved and maintained for 20 weeks, participants will be randomly assigned to one of the following five maintenance treatments for 36 months: psychotherapy plus imipramine; psychotherapy plus placebo; psychotherapy alone; medication clinic treatment plus imipramine; or medication clinic treatment plus placebo. Assessments will be made at Weeks 12 and 20 and Months 7, 11, and 36, and will include the time it takes for depression symptoms to recur, as well as scores on depression and mania severity scales.
- Conditions
- Depression
- Being tested
- Imipramine, Interpersonal Psychotherapy
- Keywords
- Major depression
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImipramineDrug
Interpersonal PsychotherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence of depression symptoms
Secondary outcomes (1)
Measured at Months 7, 11, and 36: Score on the Raskin Depression and Mania Severity Scales
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startDec 1987
- Study completionDec 1993
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
- 200 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Ellen Frank, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227955
- Sponsor's protocol ID
- 871250
- Status last verified
- Jun 2013
- First submitted
- 26 Sep 2005
- Last updated
- 25 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapies in Recurrent Depression-Study I
- ClinicalTrials.gov ID
- NCT00227955
- Acronym / sponsor ID
- 871250
- Conditions
- Depression
- Keywords
- Major depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Dec 1987
- Study completion
- Dec 1993
- First posted
- 28 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 study will evaluate the effectiveness of five combinations of drug therapy and psychotherapy in maintaining remission of depression symptoms in people with recurrent major depression.
Detailed description
Depression is a serious illness that can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that once were pleasurable. It is characterized by several symptoms, such as the following: persistent sad, anxious, or "empty" mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. If left untreated, depression symptoms can last for years, and may worsen as time goes on. Even with treatment, however, it is possible for depression to recur. Remission is a main goal in the treatment of depression and it may be accomplished through various strategies. This study will evaluate the effectiveness of five combinations of treatments, including medication therapy and psychotherapy, in maintaining remission of depression symptoms.
All participants in this study will first be treated with imipramine for 7 to 11 months. Once remission of depression symptoms has been achieved and maintained for 20 weeks, participants will be randomly assigned to one of the following five maintenance treatments for 36 months: psychotherapy plus imipramine; psychotherapy plus placebo; psychotherapy alone; medication clinic treatment plus imipramine; or medication clinic treatment plus placebo. Assessments will be made at Weeks 12 and 20 and Months 7, 11, and 36, and will include the time it takes for depression symptoms to recur, as well as scores on depression and mania severity scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of recurrent major depression
Key exclusion criteria (2 listed)
- Unstable medical illness
- Any other simultaneous psychiatric or medical illness of greater concern than depression (index episode of depression is not primary)
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 |
|---|---|---|
| Imipramine | Drug | – |
| Interpersonal Psychotherapy | Behavioural | – |
Primary outcome
Time to recurrence of depression symptoms
1 secondary outcome
Measured at Months 7, 11, and 36: Score on the Raskin Depression and Mania Severity Scales
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 25 Jun 2013.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
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
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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, PhD 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 Imipramine and Interpersonal Psychotherapy in people with 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 1 inclusion and 2 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 25 Jun 2013. 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?
Time to recurrence of depression symptoms. 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 25 Jun 2013.