Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00206544




Registration number
NCT00206544
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
24/10/2008

Titles & IDs
Public title
Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?
Scientific title
Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?
Secondary ID [1] 0 0
03T-415
Secondary ID [2] 0 0
APRC 77/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 0 0
Mania 0 0
Schizoaffective Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Progesterone
Other interventions - placebo

Active Comparator: 1 - Tamoxifen 40 mg daily

Active Comparator: 2 - Progesterone 20 mg daily

Placebo Comparator: 3 - Placebo daily


Treatment: Drugs: Tamoxifen
40 mg daily of adjunctive tamoxifen in oral capsule

Treatment: Drugs: Progesterone
20 mg daily of adjunctive progesterone in oral capsule

Other interventions: placebo
adjunctive placebo daily in oral capsule
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Scores on CARS-M Scale at trial completion
Timepoint [1] 0 0
Baseline and weeks 1, 2, 3 and 4
Secondary outcome [1] 0 0
Scores on PANSS at trial completion (4 weeks)
Timepoint [1] 0 0
Baseline and weeks 1, 2, 3 and 4
Secondary outcome [2] 0 0
Scores on MADRS at trial completion (4 weeks)
Timepoint [2] 0 0
Baseline and weeks 1, 2, 3 and 4
Secondary outcome [3] 0 0
Scores on Adverse Symptom Checklist at trial completion (4 weeks)
Timepoint [3] 0 0
Baseline and weeks 1, 2, 3 and 4
Secondary outcome [4] 0 0
Change in hormone levels over trial duration
Timepoint [4] 0 0
Baseline and weeks 1, 2, 3 and 4
Secondary outcome [5] 0 0
Scores on RBANS at trial completion (4 weeks)
Timepoint [5] 0 0
Baseline and week 4

Eligibility
Key inclusion criteria
- Female patients who have a current diagnosis of Bipolar Affective Disorder (Manic
phase) or Schizoaffective Disorder (Bipolar type in manic phase).

- Female patients who are able to give informed consent.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Female patients who are pregnant or lactating.

- Female patients with postpartum psychosis or related disorder.

- Female patients with known abnormalities in the hypothalamo-pituitary gonadal-axis,
thyroid dysfunction, central nervous system tumors.

- Female patients taking estrogen preparations such as the oral contraceptive pill.

- Female patients currently taking interacting drugs including warfarin,
aminoglutethimide, diuretics, methyldopa, theophylline, fluoxetine, calcium channel
blockers and non-steroidal anti-inflammatory drugs.

- Female patients whose psychotic illness is directly due to illicit drugs or who have a
history of substance abuse or dependence during the last 6 months.

- Females with any significant unstable medical illness such as cardiovascular disease,
renal disease, Addisons disease, thromboembolic disorders, epilepsy, diabetes etc.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Bayside Health - The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Stanley Medical Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
OBJECTIVE:

To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind,
placebo-controlled study in the treatment of acute mania/hypomania.

HYPOTHESIS:

That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and
more substantial decrease in manic symptoms over the course of the study than women receiving
adjunctive placebo.

STUDY POPULATION:

Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective
disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and
Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association.

STUDY MEDICATION:

Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen
at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to
maintain "blinding" of treatment arm.

Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral
Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain
capsule identical to that used with Tamoxifen.

Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo
(inert substance). The placebo substance will be administered within a plain capsule
identical to that used with Tamoxifen and Progesterone.

STUDY EVALUATIONS:

Data will be collected over a 28-day period for each patient. Visits will be performed at
baseline, and then at weekly intervals. A total of five visits will be completed for each
patient. The following evaluations will be performed:

- Psychiatric evaluation to determine diagnosis. (Baseline visit only)

- General clinical evaluation including medical history, current conditions and a
non-invasive physical examination, body weight, vital signs. (Baseline visit only)

- Medication history (baseline and evaluation visits).

- Demographics (baseline visits only).

- Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale
(BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle
Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint
(day 28) visit.

- Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH),
follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin,
dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and
evaluation visits).

- Inclusion/exclusion checklist (baseline visit only).

- Informed consent (baseline visit only).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00206544
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD
Address 0 0
Bayside Health / Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00206544