DepressionPhase 2NCT00000390
Antidepressant Treatment of AIDS Related Depression.
A Phase 2 study testing Imipramine hydrochloride in people with Depression, run by GEIGY Pharmaceuticals at 1 site in United States.
Trial summary
To test the effectiveness treating AIDS related depression with imipramine hydrochloride. Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Imipramine hydrochloride
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patient must be ambulatory and relatively good health. Even if unable to work at least able to partially care care for self and not demented.
- May have been alcoholic or drug abuser 6 months previous.
- Unspecified
- CD4 Unspecified.
Who cannot join
- Non ambulatory patients or those requiring extensive help in self care are excluded.
- Non ambulatory patients or those requiring extensive help in self care are excluded.
- Current alcohol or drug abuse.
- Unspecified
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Hosp - Cornell Med Ctr
New York, New York, 10021
About this study
To test the effectiveness treating AIDS related depression with imipramine hydrochloride.
Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status.
This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride.
Read the detailed description
To test the effectiveness treating AIDS related depression with imipramine hydrochloride.
Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status.
This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride.
- Conditions
- Depression
- Being tested
- Imipramine hydrochloride
- Keywords
- Adult, Acquired Immunodeficiency Syndrome, Depression, Female, Human, Imipramine, Male, Middle Age, Acquired Immunodeficiency Syndrome -- *complications, Depression -- *drug therapy, Depression -- etiology, Imipramine -- *therapeutic use
- Medical subject headings
- Depression, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imipramine hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2000 (estimated)
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.
- 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
Sponsor and investigators
- Lead sponsor
- GEIGY Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frances A, Study chairManning D, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000390
- Sponsor's protocol ID
- R01MH042952
- Other IDs
- 87-DEP
- Status last verified
- Apr 2000
- First submitted
- 17 Jan 2000
- Last updated
- 23 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidepressant Treatment of AIDS Related Depression.
- ClinicalTrials.gov ID
- NCT00000390
- Acronym / sponsor ID
- R01MH042952
- Conditions
- Depression
- Keywords
- Adult, Acquired Immunodeficiency Syndrome, Depression, Female, Human, Imipramine, Male, Middle Age
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- GEIGY PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 18 Jan 2000 (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.
To test the effectiveness treating AIDS related depression with imipramine hydrochloride.
Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status.
This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride.
Detailed description
To test the effectiveness treating AIDS related depression with imipramine hydrochloride.
Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status.
This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must be ambulatory and relatively good health. Even if unable to work at least able to partially care care for self and not demented.
- May have been alcoholic or drug abuser 6 months previous.
- Unspecified
- CD4 Unspecified.
Key exclusion criteria (4 listed)
- Non ambulatory patients or those requiring extensive help in self care are excluded.
- Non ambulatory patients or those requiring extensive help in self care are excluded.
- Current alcohol or drug abuse.
- Unspecified
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 hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 23 Apr 2015.
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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.
Frances A study chair
Manning D study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imipramine hydrochloride in people with Depression, run by GEIGY Pharmaceuticals 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 4 inclusion and 4 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 23 Apr 2015. 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 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?
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.
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 23 Apr 2015.