Major Depressive DisorderPhase 2NCT00593879
Flexible Dose Titration Add-on Study to Treat Major Depressive Disorder
A Phase 2 study testing Mecamylamine in people with Major Depressive Disorder, run by Targacept Inc..
Trial summary
Depressed patients will receive 6 weeks of citaloprma (20-40mg) therapy. Subjects who have an inadequate response (partial or non-responder) will be randomized to receive either mecamylamine (5-10mg) or placebo added to their citalopram for a further 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Mecamylamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Aug 2006
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open Phase
- Male or female subjects aged 18-70 years.
- Diagnosis of major depressive disorder (MDD) according to DSM-IV and confirmed via MINI diagnostic scale.
- Able to give written informed consent.
- HAMD-17 score greater than 21.
- CGI-Severity of Illness score greater than or equal to 4.
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- No clinically significant abnormality on physical examination, vital signs, ECG or laboratory tests (biochemical, hematological, urinary) at screening.
- Women of child bearing potential with a negative urine pregnancy test and willing to use acceptable methods of contraception.
- (B)Double Blind Phase:
- Subjects still to meet DSM-IV criteria for MDD.
- Subjects continue to meet all of the inclusion and exclusion criteria.
- HAMD-17 score greater than or equal to 14.
- CGI severity of illness score greater than or equal to 4.
- Women of child bearing potential with a negative urine pregnancy test and willing to use acceptable methods of contraception.
Who cannot join
- Aged below 18 years and above 70 years.
- Failure to meet DSM IV criteria for MDD.
- HAMD-17 less than or equal to 21 (open-label phase only).
- CGI Severity of Illness score less than 4.
- Clinically significant changes in physical examination, vital signs, ECG or laboratory tests at screening.
- Any other co morbid psychiatric illness confirmed by MINI diagnostic scale, especially bi-polar disorder, schizophrenia or dementia.
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- Subjects with significant suicidal risk upon clinical assessment.
- Subjects who have treatment resistant depression i.e. who have failed adequate course (daily dose and duration of treatment) of one or more antidepressants.
- History of alcohol or drug abuse over the last 6 months.
- History of seizures or seizure disorders.
- Seropositive for HIV or hepatitis B (antibody or antigen).
- Any other severe progressive and uncontrolled medical condition.
- For controlled other medical conditions, medication to be unchanged over the 2 months preceding screening, or else the patient will be excluded.
- Subjects with Glaucoma, Kidney Disease or Heart Disease.
- Known hypersensitivity to mecamylamine.
- Women of child bearing potential not taking adequate contraception and women breastfeeding.
- Other investigational drug in previous 30 days.
About this study
Official title: A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group, Flexible Dose Titration, Add-On Study of Mecamylamine 5.0 to 10 mg, in the Treatment of Major Depressive Disorder With Subjects Who Are Partial or Non- Responders to Citalopram Therapy.
Depressed patients will receive 6 weeks of citaloprma (20-40mg) therapy. Subjects who have an inadequate response (partial or non-responder) will be randomized to receive either mecamylamine (5-10mg) or placebo added to their citalopram for a further 8 weeks.
Read the detailed description
This is a double blind, randomized, placebo controlled, parallel group, flexible dose titration, add-on study. Male or female subjects aged 18-70 years suffering from Major Depressive Disorder according to DSM-IV, with a HAMD-17 score greater than 21 and a CGI-Severity of Illness score greater or equal to 4, will be started on open labeled citalopram treatment. The dose of citalopram may be increased form 20mg to 40mg over a six week period, depending on investigator assessment of tolerability and efficacy. At the end of this treatment, subjects with a HAMD-17 score greater or equal to 14 and a CGI-Severity of Illness score greater or equal to 4 will be considered as partial or non-responders and will be entered into the double blind phase of the study. Subjects will be randomized to either mecamylamine or placebo for a further 8 weeks. Citalopram medication will remain constant while mecamylamine (or placebo) can be increased from 5.0 to 7.5 to 10.0mg based on investigator assessment of tolerability and efficacy.
Plasma samples for citalopram assay will be collected at the start and end of the double blind phase to exclude any mecamylamine effect being due to a drug:drug interaction.
Approximately 500 subjects will be entered into the open-label phase of the study and approximately 160 into the double blind phase. The study will be conducted in India and the USA.
- Conditions
- Major Depressive Disorder
- Being tested
- Mecamylamine
- Keywords
- MDD, Depression, Mecamylamine, Add-on Therapy, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MecamylamineDrug
Also called Inversine
2.5mg mecamylamine Hcl, tablet form taken twice a day (total of 5.0mg). For 7.5 mg dose group, 2 tablets taken morning, one tablet evening. At 10.0mg, 2 tablets taken twice daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Mecamylamine |
| 2 | Experimental | Not described Receives: Drug: Mecamylamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMD-17 group mean change from baseline to endpoint and/or the proportion of subjects considered to be full responders or in remission with a HAMD-17 score less than or equal to 7 at the end of treatment.
Measured: 8 weeks
Secondary outcomes (3)
Montgomery Asbery depression rating sclae, Clinical Global Impression Scale - Severity, Clinical Global Impression Sacle - Change, Sheehan irritability scale, Sheehan disability scale
Measured: 8 weeks
Blood biochemistry, urnie analysis, blood pressure, heart rate, ECG
Measured: 8 weeks
Citalopram plasma bloods at week 6 and 14.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startFeb 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targacept Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Geoffrey C Dunbar, MD, Study director, Targacept Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593879
- Sponsor's protocol ID
- TC-5231-023-CRD-003
- Status last verified
- Jan 2008
- First submitted
- 19 Dec 2007
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group, Flexible Dose Titration, Add-On Study of Mecamylamine 5.0 to 10 mg, in the Treatment of Major Depressive Disorder With Subjects Who Are Partial or Non- Responders to Citalopram Therapy.
- ClinicalTrials.gov ID
- NCT00593879
- Acronym / sponsor ID
- TC-5231-023-CRD-003
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Depression, Mecamylamine, Add-on Therapy, Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Targacept Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- Aug 2006 (actual)
- First posted
- 15 Jan 2008 (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.
Depressed patients will receive 6 weeks of citaloprma (20-40mg) therapy. Subjects who have an inadequate response (partial or non-responder) will be randomized to receive either mecamylamine (5-10mg) or placebo added to their citalopram for a further 8 weeks.
Detailed description
This is a double blind, randomized, placebo controlled, parallel group, flexible dose titration, add-on study. Male or female subjects aged 18-70 years suffering from Major Depressive Disorder according to DSM-IV, with a HAMD-17 score greater than 21 and a CGI-Severity of Illness score greater or equal to 4, will be started on open labeled citalopram treatment. The dose of citalopram may be increased form 20mg to 40mg over a six week period, depending on investigator assessment of tolerability and efficacy. At the end of this treatment, subjects with a HAMD-17 score greater or equal to 14 and a CGI-Severity of Illness score greater or equal to 4 will be considered as partial or non-responders and will be entered into the double blind phase of the study. Subjects will be randomized to either mecamylamine or placebo for a further 8 weeks. Citalopram medication will remain constant while mecamylamine (or placebo) can be increased from 5.0 to 7.5 to 10.0mg based on investigator assessment of tolerability and efficacy.
Plasma samples for citalopram assay will be collected at the start and end of the double blind phase to exclude any mecamylamine effect being due to a drug:drug interaction.
Approximately 500 subjects will be entered into the open-label phase of the study and approximately 160 into the double blind phase. The study will be conducted in India and the USA.
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 |
|---|---|---|
| 1 | Placebo comparator | Drug: MecamylaminePlacebo |
| 2 | Experimental | Drug: Mecamylamine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Open Phase
- Male or female subjects aged 18-70 years.
- Diagnosis of major depressive disorder (MDD) according to DSM-IV and confirmed via MINI diagnostic scale.
- Able to give written informed consent.
- HAMD-17 score greater than 21.
Key exclusion criteria (17 listed)
- Aged below 18 years and above 70 years.
- Failure to meet DSM IV criteria for MDD.
- HAMD-17 less than or equal to 21 (open-label phase only).
- CGI Severity of Illness score less than 4.
- Clinically significant changes in physical examination, vital signs, ECG or laboratory tests at screening.
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 |
|---|---|---|
| MecamylamineAlso: Inversine2.5mg mecamylamine Hcl, tablet form taken twice a day (total of 5.0mg). For 7.5 mg dose group, 2 tablets taken morning, one tablet evening. At 10.0mg, 2 tablets taken twice daily. | Drug | 1, 2 |
Primary outcome
HAMD-17 group mean change from baseline to endpoint and/or the proportion of subjects considered to be full responders or in remission with a HAMD-17 score less than or equal to 7 at the end of treatment.
Time frame: 8 weeks
3 secondary outcomes
Montgomery Asbery depression rating sclae, Clinical Global Impression Scale - Severity, Clinical Global Impression Sacle - Change, Sheehan irritability scale, Sheehan disability scale
Time frame: 8 weeks
Blood biochemistry, urnie analysis, blood pressure, heart rate, ECG
Time frame: 8 weeks
Citalopram plasma bloods at week 6 and 14.
Time frame: 8 weeks
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 2008.
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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.
Geoffrey C Dunbar, MD study director
Targacept Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mecamylamine in people with Major Depressive Disorder, run by Targacept Inc..
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 14 inclusion and 17 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 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
HAMD-17 group mean change from baseline to endpoint and/or the proportion of subjects considered to be full responders or in remission with a HAMD-17 score less than or equal to 7 at the end of treatment. (time frame: 8 weeks). 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 2008.